COVID-19 Research Newsletter Highlight & Updated Handout!

Email Newsletter Archive | Friday, March 11, 2021

Read the Newsletter Here

 

Hello,

We’re excited to reach out to you with what we hope will become a new tradition… a research newsletter from Evidence Based Birth®!

From now on, instead of our regular COVID-19 research updates, we’re going to combine that info with news from other pregnancy and childbirth-related research!! So basically, you’re getting a behind-the-scenes look at the types of research, history, and anti-racism info we are always sharing in our private Research Team meetings.

And by the way… we’d love to introduce you to our EBB Research Team! Those of us who will be putting this newsletter together include:

  • Rebecca Dekker, PhD, RN (she/her) is the founder and CEO of Evidence Based Birth®. She’s been writing research articles that start with “The Evidence on..” at EBB for 10 years now! Dr. Dekker lives in Lexington, Kentucky, with her family and pets. Her favorite article from EBB is the “Evidence and Ethics on Circumcision,” although the “Evidence on Vitamin K” was also one that put EBB in the spotlight (and generated a lot of heat!)
  • Ihotu Ali, LMT, MPH (she/her) is a former maternal mortality researcher with the United Nations in Africa, Asia, and the Caribbean. She turned to holistic birth and womb care over the last 10 years as a doula, prenatal and Maya Abdominal massage therapist, and chiropractic physician-in-training. She calls Minnesota, New York City, and Nigeria home, and loves Minnesota summers (short as they are!) with family and friends. She also hosts retreats and teaches with the MN Healing Justice Network and Oshun Center for Intercultural Healing.
  • Erin Wilson, MPH (she/her) is a clinical researcher turned birth doula and childbirth educator. She worked for 10 years running clinical trials in a hospital setting before making the switch to full-time birth work. After living that on-call doula life for many years, she is so happy to have found a home here at Evidence Based Birth®–a place where she can combine her experience in research and passion for quality, evidence-based care! Erin lives in the mountains of Colorado with her family and pets. She loves to cook, hike, and try to keep her chickens alive.

​Since our last COVID-19 newsletter, we’ve noted several updates in the research. We’ve also been interested to see more vaccine research that focuses specifically on pregnant people!


COVID-19 Research Update

​Written by Erin Wilson, MPH

New Research About the Effectiveness of COVID Vaccines in Pregnancy

On February 15, 2022, new information from a CDC-led research study was published online in their Morbidity and Mortality Weekly Report (MMWR). While previous studies have demonstrated that protective antibodies pass from people vaccinated in pregnancy to their babies, this important research is the first to look at whether these antibodies could actually prevent illness in babies.

In this study, researchers from the CDC looked at the medical records of 379 infants who were hospitalized for various reasons in 17 states from July 1, 2021 through January 17, 2022. Of the infants hospitalized with COVID-19, 84% had birth parents who did not receive a COVID vaccine in pregnancy (Halasa, Olson, Staat, et al. 2022).

Fully vaccinated in this study was defined as having two doses of an mRNA COVID-19 vaccine (Moderna or Pfizer) during pregnancy. The researchers did not look at the Johnson and Johnson vaccine or at booster doses of any vaccine. The calculated decrease in relative risk was 61%, meaning that babies born to parents vaccinated in pregnancy were 61% less likely to be hospitalized within the first 6 months of life from SARS-CoV-2 infection.

You can read NPR’s summary of this study here or check out the full MMWR here.

More Details on Antibody Response in Infants Born to Vaccinated Parents

Another related recent study, published in February 2022 as a research letter in the Journal of the American Medical Association (JAMA), gives a more detailed picture of the protective antibodies that pass from both vaccinated and infected pregnant parents to their babies.

In this study, researchers looked at the antibody levels present in babies at the time of birth, 2 months, and 6 months postpartum. Patients could be included in the study if they received a COVID vaccine or had natural SARS-CoV-2 infection between 20 and 32 weeks of pregnancy. This window was chosen because previous studies have shown that antibody transfer from vaccines is highest during this time (Shook, Atyeo, Yonker, et al. 2022).

The study included patients from two academic medical centers in Boston, Massachusetts who consented to participate and complete follow-up visits with their infants. Some of the group did not come back for follow-up, possibly because it was difficult to come to an in-person research visit with an infant in a pandemic. In total, there were 77 people who received vaccines in pregnancy and 12 pregnant people with natural infection in the study group.

All 77 participants had cord blood samples taken shortly after birth to check the antibody levels that were transferred to their babies. At 2 months, 49 infants born to vaccinated pregnant study participants had their antibody levels checked through a small blood sample. At 6 months, 28 of these infants had their blood drawn a second time, and 12 infants born to study participants with natural infections also had their blood drawn.

At the blood draw immediately postpartum, the vaccinated group had significantly higher antibody levels than the natural infection group. At two months, 98% of the infants in the vaccinated group still had protective antibodies in their blood sample. Please note that at two months there was not a blood draw for the natural infection group-this was due to a wave of infection in Boston and the unavailability of study participants during this window. At six months, 57% of the infants in the vaccinated group still had protective antibodies in their blood sample as compared to 8% of the infants in the natural infection group.

This study adds to the growing body of evidence that COVID vaccination in pregnancy causes an immune response in the pregnant parent that is transferred to the baby in utero. Some limitations of this research are the small sample size, which is typical in studies that involve human samples, and the lack of follow-up at two months for the natural infection group. The researchers note that the study provides important evidence about immunity in babies 6 months and younger– a group that has a disproportionate amount of severe illness, and for whom vaccines are not currently being developed.

Here is a link to the research letter if you would like to learn more.

COVID Vaccine for Children and Adolescents-Decreasing Efficacy in the Omicron Era

New research, that is not yet peer-reviewed and has been released only on a pre-print server at this time, is showing that the efficacy of the Pfizer COVID-19 vaccine is decreasing over time, particularly for 5 to 11-year-olds. Estimates using data from the medical records of over 1.2 million children and adolescents in New York are showing that, although severe disease and hospitalization are still largely prevented by the vaccines, their efficacy at preventing infection has significantly dropped against Omicron.

One possible theory is that the decreasing efficacy is due to the dosing of the pediatric vaccine (for children ages 5-11), which is 1/3 the dose of the adult version. This could explain the more dramatic decrease in efficacy in the younger age group as compared to the adolescent group. Researchers suggest that alternate dosing should be studied for 5 to 11-year-olds along with the continued use of other prevention strategies (Dorabamila, Hoefer, Bauer, et al. 2022).

Here is a summary of the results from December 13, 2021-January 30, 2022:

One other important note: when researchers separated the children and adolescents by years of age, they found the biggest difference in efficacy was between the 11-year-olds, who received the smaller pediatric dose, and 12-year-olds, who received the adult dose. From data collected the week of January 24-30, vaccine efficacy for 11-year-olds in the study was 11% and vaccine efficacy for 12-year-olds in the study was 67%. This huge difference in efficacy is more evidence of probable issues with the dosing of the pediatric vaccine.

This is a major setback in the campaign to vaccinate children and adolescents against COVID-19. It comes just weeks after Pfizer and the FDA decided to delay pursuing an emergency use authorization for the youngest children aged 6 months to 4 years. More data on this age group will be reviewed in the coming weeks. Here is a summary of this information from NPR if you’d like to read more.

  • This article summarizes a recent study, published in The Journal of Obstetrics and Gynecology, in which researchers analyzed blood samples from 1,359 pregnant people who received a COVID-19 vaccine shortly before or during pregnancy (Yang et al., Dec. 2021).
  • The goal of this study was to get a clearer picture of the immunity that passes from a vaccinated pregnant person to their baby. Researchers wanted to understand if there is a relationship between when the vaccine is given in pregnancy (the gestational age) and the immune response the vaccine causes. In other words: is there is an ideal time to get vaccinated during pregnancy?
  • Study participants were included if they received a vaccine from 6 weeks prior to conception through 41 weeks in pregnancy. There was also a group who had natural COVID-19 infection and a small sample (20 people) who received booster doses. Participants were included in the final analysis if they gave birth at or beyond 34 weeks and did not have an active COVID-19 infection at the time they were admitted to the hospital for delivery.
  • Researchers collected blood samples from pregnant people as well as from their baby’s umbilical cord. They measured each participant’s immune response by comparing the antibody levels found in these two samples.
  • Antibodies against COVID-19 were found in all blood samples, regardless of when patients received their vaccine.
  • The highest level of antibodies in the cord blood, and thus passing on to babies, was found in pregnant people who became fully vaccinated in their third trimester or who received a booster dose in their third trimester.
  • The lowest levels (though still detectable) were found in pregnant people who received their vaccines pre-pregnancy or in the first trimester and did not receive a booster dose.
  • The researchers caution that their results should not cause pregnant people to delay vaccination until the third trimester.
  • Rather, they emphasize the importance of a fully completed vaccine series in pregnancy, stating that vaccination at any stage generates valuable immune protection from a potentially serious disease (Yang et al., 2021).
  • You can read the full text of the article here.

That concludes this month’s COVID-19 update from Evidence Based Birth®.

Sincerely,

The Evidence Based Birth® Research Team

Receive more updates on COVID-19 and other birth topics when you sign up for our NEW monthly Research Newsletters!

 

View the Scientific References Here

COVID-19 References:

Halasa Natasha, Olson Samantha, Staat Mary, et al. (2022). Effectiveness of Maternal Vaccination with mRNA COVID-19 Vaccine During Pregnancy Against COVID-19-Associated Hospitalization in Infants Aged < 6 months-17 States, July 2021-January 2022. MMWR early release published online February 15, 2022. Click here.

Shook Lydia, Atyeo Caroline, Youker Lael, et al. (2022). Durability of Anti-Spike Antibodies in Infants After Maternal COVID-19 Vaccination or Previous Maternal Infection. JAMA. Published online February 7, 2022. Click here.

Ismailora Inara, Sokol Robert, Gudicha Dereje, et al. (2022). Racial Disparities and Risk for COVID-19 Among Pregnant Patients: Results from the Michigan Statewide Collaborative. AJOG. 01 Jan 2022. Click here.

Dorabamila Vajeera, Hoefer Diana, Bauer E, et al. (2022). Effectiveness of the BNT162b2 vaccine among children 5-11 and 12-17 years in New York after the Emergence of the Omicron Variant. MedRxiv pre-print published online February 28, 2022. Click here.

A SPECIAL MESSAGE FROM DR. REBECCA DEKKER

Founder and CEO of Evidence Based Birth®

 Hi Everyone,

It’s Rebecca, here. We made it through the past two years of a global pandemic! We discovered that through it all our goal remains the same: to provide you with friendly, accessible, evidence based information so that you can make informed decisions.

As we move forward, our goal is more important than ever.

At Evidence Based Birth®, we now offer a FREE monthly newsletter where our research team is examining the best available data for not only COVID-19 but a more robust body of evidence topics related to pregnancy and birth. We will keep this page updated with resources and relevant information for both pregnant parents and birth professionals.

I can’t wait for you to sign up to read this month’s research newsletter topics!

Wishing you all the best,

Rebecca

VIRTUAL CHILDBIRTH EDUCATION FOR BIRTHING FAMILIES DURING COVID-19

Evidence Based Birth® has moved its pioneering Childbirth Class completely online, taught by our Evidence Based Birth® Instructors. The best way to get enrolled in our completely online Childbirth Class is to click on the button below!

Archives of Past Evidence Based Birth® Research Updates on COVID-19

Research Update for February 11, 2022

Hello,

We’re excited to reach out to you with what we hope will become a new tradition… a research newsletter from Evidence Based Birth®!

From now on, instead of our regular COVID-19 research updates, we’re going to combine that info with news from other pregnancy and childbirth-related research!! So basically, you’re getting a behind-the-scenes look at the types of research, history, and anti-racism info we are always sharing in our private Research Team meetings.

And by the way… we’d love to introduce you to our EBB Research Team! Those of us who will be putting this newsletter together include:

  • Rebecca Dekker, PhD, RN (she/her) is the founder and CEO of Evidence Based Birth®. She’s been writing research articles that start with “The Evidence on..” at EBB for 10 years now! Dr. Dekker lives in Lexington, Kentucky, with her family and pets. Her favorite article from EBB is the “Evidence and Ethics on Circumcision,” although the “Evidence on Vitamin K” was also one that put EBB in the spotlight (and generated a lot of heat!)
  • Ihotu Ali, LMT, MPH (she/her) is a former maternal mortality researcher with the United Nations in Africa, Asia, and the Caribbean. She turned to holistic birth and womb care over the last 10 years as a doula, prenatal and Maya Abdominal massage therapist, and chiropractic physician-in-training. She calls Minnesota, New York City, and Nigeria home, and loves Minnesota summers (short as they are!) with family and friends. She also hosts retreats and teaches with the MN Healing Justice Network and Oshun Center for Intercultural Healing.
  • Erin Wilson, MPH (she/her) is a clinical researcher turned birth doula and childbirth educator. She worked for 10 years running clinical trials in a hospital setting before making the switch to full-time birth work. After living that on-call doula life for many years, she is so happy to have found a home here at Evidence Based Birth®–a place where she can combine her experience in research and passion for quality, evidence-based care! Erin lives in the mountains of Colorado with her family and pets. She loves to cook, hike, and try to keep her chickens alive.


COVID-19 Research Highlight and Handout Update!

Written by Erin Wilson, MPH


Today, along with this newsletter, we are also releasing an updated version of our Vaccines in Pregnancy Handout. The handout contains some new research as well as any approvals and recommendations that have been released since our last handout version from December 2021.

You can download the updated handout here!

Here is a summary of the changes we’ve made to the handout:

  • Mention of the full FDA approval of the Moderna mRNA vaccine
  • Discussion of the submission of clinical data on a lower-dose Pfizer/BioNTech mRNA vaccine for children ages 6 months to 4 years old
  • More information on if and when this vaccine will be available under an Emergency Use Authorization (EUA) is expected after the FDA Advisory Committee meets next week on February 15, 2022
  • Updated CDC tracker numbers on people who received a vaccine during pregnancy
  • Updated booster shot recommendations for all people ages 12 and up–this includes pregnant and lactating people as well as those trying to become pregnant or wanting to become pregnant soon

Some interesting new research focused on fertility has recently been published in the American Journal of Epidemiology. While several studies have debunked theories about COVID-19 vaccines and infertility, new research suggests a link between SARS-CoV-2 infection and a temporary decrease in male fertility (Wesselink, 2022).

In this study, investigators looked back in time at the medical records of over 2000 U.S. and American couples trying to conceive without fertility treatments. The couples in the study were all heterosexual and identified as male-female partnerships. Participants completed surveys every 8 weeks until they conceived, or for up to 12 months if they did not conceive. Here is a summary:

  • Study data came from PRESTO (Pregnancy Study Online), an online pregnancy study looking at whether lifestyle factors such as diet, exercise, and medications have an impact on fertility and pregnancy. The database is run by Boston University’s School of Public Health.
  • Study participants completed questionnaires about their medical and reproductive history and indicated whether either partner received any COVID-19 vaccines or had natural SARS-CoV-2 infection.
  • As has been seen in other research, there were no major differences in conception rates per menstrual cycle in vaccinated and unvaccinated study participants. However, when the male partner had SARS-CoV-2 infection within 60 days of a given menstrual cycle, the couples were 18% less likely to conceive during that cycle.
  • The decreased fertility was temporary, and when SARS-CoV-2 infection occurred more than 60 days before a given menstrual cycle, conception rates were not affected.
  • One theory about the decrease in fertility is fever, which is a common symptom of SARS-CoV-2 and can impact sperm count and motility (movement). Another possible explanation is inflammation of the testes and surrounding tissue and erectile dysfunction, which can both occur after SARS-CoV-2 infection.
  • Here is a summary of this study from the National Institutes of Health (NIH) and here is a link to the PRESTO database if you would like to learn more or consider enrolling.

We have received some questions in our private Pro Member forums (in the “Ask our Research Team” feature for Pro Members) about the use of monoclonal antibodies to treat SARS-CoV-2 in pregnancy. We wanted to provide some information on that topic.

First, anti-spike monoclonal antibodies were approved by the FDA under an Emergency Use Authorization (EUA) to treat mild-to-moderate COVID-19 in people with certain pre-existing conditions. In May 2021, this definition was expanded to include pregnant people.

Data on the use of monoclonal antibodies in pregnancy are, so far, limited. A research letter published in the January 2022 issue of Obstetrics and Gynecology reviews the cases of 51 pregnant people with mild-to-moderate COVID-19 who received this treatment. Here is a summary of that information:

  • In this review, investigators looked back in time at the medical records of pregnant people who received monoclonal antibodies as a treatment for COVID-19 at a single medical center over a one-year period. 51 people met inclusion criteria for the study.
  • All the patients received their monoclonal antibody infusion in an outpatient area and were observed for one hour following the procedure. None of the patients had adverse reactions during the observation period.
  • During the 28-day study period following their treatment, 10 patients sought care at the emergency room. Only one of these visits was due to COVID-19 symptoms, the rest were for unrelated pregnancy concerns. None of the patients required further COVID-related care or had major pregnancy complications.
  • Although these results are reassuring, the investigators caution that more studies are needed to study larger and more diverse populations as well as longer follow-up periods for pregnant people and babies.
  • Here is a link to the summary.

Some other interesting and related links:

  • Here is a link to the FDA’s press release about the potential for another EUA to be approved in the coming weeks for a lower-dose vaccine for young children ages 6 months to 4 years.
  • Here is a link to the CDC’s Omicron page, which contains updated information about the variant and how the vaccines are impacting the current surge.
  • This is a link to a fascinating, recent episode of the NY Times’ podcast, The Daily. It summarizes the results of a poll of 4,400 people in the U.S. and how they feel about COVID-19 at this point in the pandemic.
    • For many people in the U.S., Omicron is a turning point and the results may really surprise you!
    • There are many differences in viewpoint and the responses mostly align around three factors: age, political party, and vaccination status.
    • Disclaimer: the results are not always in line with science or evidence but are very thought provoking and, we hope, can help us all understand each other a little more!
    • Here is a link to the poll if you prefer to read the results directly.

That concludes this month’s COVID-19 update from Evidence Based Birth®.

Sincerely,

The Evidence Based Birth® Research Team

Receive more updates on COVID-19 and other birth topics when you sign up for our NEW monthly Research Newsletters!

COVID-19 References

  • Wesselink Amelia, Hatch Elizabeth, Rothman Kenneth, et al. (2022). A prospective cohort study of COVID-19 infection, SARS-CoV-2 infection, and fertility. American Journal of Epidemiology. 20 January 2022. Read here.
  • Thilager, Bright, Ghosh Aditya, Nguyen Jerome, et al. (2022). Anti-Spike Monoclonal Antibody Therapy in Pregnant Women with Mild-to-Moderate Coronavirus Disease 2019 (COVID-19). Research Letter, Obstetrics and Gynecology. 13 January 2022. Read here.

Research Update for January 14, 2022

Hello,

We’re excited to reach out to you with what we hope will become a new tradition… a research newsletter from Evidence Based Birth®!

From now on, instead of our regular COVID-19 research updates, we’re going to combine that info with news from other pregnancy and childbirth-related research!! So basically, you’re getting a behind-the-scenes look at the types of research, history, and anti-racism info we are always sharing in our private Research Team meetings.

And by the way… we’d love to introduce you to our EBB Research Team! Those of us who will be putting this newsletter together include:

  • Rebecca Dekker, PhD, RN (she/her) is the founder and CEO of Evidence Based Birth®. She’s been writing research articles that start with “The Evidence on..” at EBB for 10 years now! Dr. Dekker lives in Lexington, Kentucky, with her family and pets. Her favorite article from EBB is the “Evidence and Ethics on Circumcision,” although the “Evidence on Vitamin K” was also one that put EBB in the spotlight (and generated a lot of heat!)
  • Ihotu Ali, LMT, MPH (she/her) is a former maternal mortality researcher with the United Nations in Africa, Asia, and the Caribbean. She turned to holistic birth and womb care over the last 10 years as a doula, prenatal and Maya Abdominal massage therapist, and chiropractic physician-in-training. She calls Minnesota, New York City, and Nigeria home, and loves Minnesota summers (short as they are!) with family and friends. She also hosts retreats and teaches with the MN Healing Justice Network and Oshun Center for Intercultural Healing.
  • Erin Wilson, MPH (she/her) is a clinical researcher turned birth doula and childbirth educator. She worked for 10 years running clinical trials in a hospital setting before making the switch to full-time birth work. After living that on-call doula life for many years, she is so happy to have found a home here at Evidence Based Birth®–a place where she can combine her experience in research and passion for quality, evidence-based care! Erin lives in the mountains of Colorado with her family and pets. She loves to cook, hike, and try to keep her chickens alive.


Research Update


Since our last COVID-19 newsletter, we’ve noted several updates in the research. We’ve also been interested to see more vaccine research that focuses specifically on pregnant people!

New Research on Vaccine Timing in Pregnancy:

 

  • This article summarizes a recent study, published in The Journal of Obstetrics and Gynecology, in which researchers analyzed blood samples from 1,359 pregnant people who received a COVID-19 vaccine shortly before or during pregnancy (Yang et al., Dec. 2021).
  • The goal of this study was to get a clearer picture of the immunity that passes from a vaccinated pregnant person to their baby. Researchers wanted to understand if there is a relationship between when the vaccine is given in pregnancy (the gestational age) and the immune response the vaccine causes. In other words: is there is an ideal time to get vaccinated during pregnancy?
  • Study participants were included if they received a vaccine from 6 weeks prior to conception through 41 weeks in pregnancy. There was also a group who had natural COVID-19 infection and a small sample (20 people) who received booster doses. Participants were included in the final analysis if they gave birth at or beyond 34 weeks and did not have an active COVID-19 infection at the time they were admitted to the hospital for delivery.
  • Researchers collected blood samples from pregnant people as well as from their baby’s umbilical cord. They measured each participant’s immune response by comparing the antibody levels found in these two samples.
  • Antibodies against COVID-19 were found in all blood samples, regardless of when patients received their vaccine.
  • The highest level of antibodies in the cord blood, and thus passing on to babies, was found in pregnant people who became fully vaccinated in their third trimester or who received a booster dose in their third trimester.
  • The lowest levels (though still detectable) were found in pregnant people who received their vaccines pre-pregnancy or in the first trimester and did not receive a booster dose.
  • The researchers caution that their results should not cause pregnant people to delay vaccination until the third trimester.
  • Rather, they emphasize the importance of a fully completed vaccine series in pregnancy, stating that vaccination at any stage generates valuable immune protection from a potentially serious disease (Yang et al., 2021).
  • You can read the full text of the article here.

New Report from the CDC on COVID-19 Vaccination in Pregnancy:

  • On January 7, 2022, the CDC released their latest Morbidity and Mortality Weekly Report (MMWR), which focused on COVID-19 vaccination in pregnancy. The report summarizes the results of a medical records review of more than 40,000 pregnant people, about 10,000 of whom received one or more COVID-19 vaccines during pregnancy.
  • While it is already known that pregnant people with COVID-19 are at an increased risk of more severe disease as well as adverse birth outcomes, such as small-for-gestational-age babies and preterm birth, vaccination rates among pregnant people remains low.
  • In this study, researchers looked back in time at births that occurred in eight different Vaccine Safety Datalink (VSD) healthcare centers across the United States to look for a possible link between COVID-19 vaccination and adverse birth outcomes. The rates of small-for-gestational-age babies and preterm birth were compared in pregnant people who received COVID-19 vaccines and pregnant people who did not. The rates of these adverse outcomes were not significantly different between the two groups.
  • Some limitations of this study are that not many people received their vaccines in the first trimester of pregnancy and that, because of the timing of the study, booster doses were not included in the analysis.
  • Per the CDC, this research strengthens the growing body of evidence that COVID-19 vaccines are safe in pregnancy. The CDC recommends COVID-19 vaccination for pregnant and lactating people as well as those who want to become pregnant soon.

Important Vaccination Study from Scotland:

  • A high-quality, population-level study from Scotland was published in Nature Medicine yesterday! (Stock et al., 2022). We anticipate this study to get a lot of media attention.
  • [Content warning: discussion of stillbirths and newborn deaths]
  • This paper came out of the COVID-19 Pregnancy in Scotland study, a prospective national study that links information about COVID-19 vaccinations, pregnancies, pregnancy outcomes, and COVID-19 PCR testing results.
  • Pregnant people in the study were categorized as unvaccinated, partially vaccinated, or fully vaccinated. Booster doses were not recommended until the very end of the study, so that info was not included in vaccination status.
  • Pregnant people were significantly less likely than non-pregnant people to be vaccinated for COVID-19. Only 32% of pregnant people in the study were fully vaccinated.
  • Looking at data from December 2020 onward, there were 4,950 confirmed SARS-CoV-2 infections in the sample of 87,694 pregnant people. Approximately 17% of these infections were associated with a hospitalization, and 2% were associated with a critical care admission. Rates of hospitalization and critical care admission were highest in the third trimester, second highest in the second trimester, and lowest in the first trimester.
  • The researchers found that COVID-vaccination during pregnancy was linked with significantly decreased SARS-CoV-2 infection rates—77.4% of all infections during pregnancy occurred in non-vaccinated pregnant people, vs. 11.5% of infections in partially vaccinated and 11.1% in fully vaccinated pregnant people.
  • Vaccination was also linked with significantly decreased hospitalization and critical care admission rates among pregnant people. Fully vaccinated pregnant people with SARS-CoV-2 had a 5.1% hospitalization rate and 0.2% critical care admission rate, compared to a 19.5% hospitalization rate and 2.7% critical care admission rate among pregnant people with SARS-CoV-2 who were not vaccinated.
  • Finally, the researchers found that all the perinatal deaths (defined as stillbirths or newborn deaths within the first 28 days of life) that occurred after SARS-CoV-2 infection (19 deaths out of 2,364 births), took place solely among pregnant people who were unvaccinated at the time of SARS-CoV-2 infection.
  • In contrast, zero stillbirths or newborn deaths occurred in pregnant people who were infected with SARS-CoV-2 but were vaccinated at the time of infection.
  • The authors did not have access to detailed hospitalization records to determine whether SARS-CoV-2 infection directly or indirectly contributed to these perinatal deaths.
  • However, 14 of the perinatal deaths took place among 620 unvaccinated pregnant people who were <28 days out from the onset of infection, making that a perinatal mortality rate of 22.6 per 1,000 births among unvaccinated pregnant people with a recent diagnosis of SARS-CoV-2 infection. This is in comparison to a perinatal mortality rate of 5.6 per 1,000 births for all pregnant people during the same time period who were not infected with SARS-CoV-2.
  • These findings reflect results from vaccination during a time in which Alpha and Delta variants were dominant in Scotland.
  • You can read the full text of the study here.

Booster Update:

    • One final update we have for you is regarding eligibility for booster doses, which has expanded since our last COVID-19 newsletter.
    • On January 7, 2022, the CDC expanded its eligibility requirements to include adolescents aged 12-15. The new recommendations include anyone age 12 and older who was vaccinated 5 months or more ago.
    • The CDC states that mRNA vaccines are preferred in most situations, though Johnson and Johnson vaccines may also be used as booster doses in some specific scenarios including allergic reactions to mRNA vaccines, vaccine availability, and personal preference.
    • Here is a link to the CDC’s booster shot guide.

That concludes this month’s COVID-19 update from Evidence Based Birth®.

Sincerely,

The Evidence Based Birth® Research Team

Receive more updates on COVID-19 and other birth topics when you sign up for our NEW monthly Research Newsletters!

Research Update for December 17, 2021

Hello,

This month’s newsletter contains a summary of vaccine recommendations that have changed in the U.S. since our last newsletter/handout, as well as some preliminary information about Omicron, the newest COVID-19 variant of concern.

In addition, we wanted to provide an update and clarification about an article from the New England Journal of Medicine that we mentioned in the EBB Vaccines in Pregnancy Handout.

We made some slight adjustments to the EBB handout on COVID-19 Vaccination in Pregnancy, and we’ve attached the updated handout here.

The changes to the handout include an update on booster recommendations and the pediatric COVID-19 vaccine, as well as an updated reference from the study that examined COVID-19 vaccination in pregnant people (Shimabukuro et al., 2021). We explain more about the updated study results at the end of this newsletter.

**Feel free to share this email and/or handout with any friends, family, clients, or colleagues who might find it helpful. If you’re a healthcare worker, feel free to print this off to share with clients or co-workers! The handout will be updated from time to time. Let people know that anyone can subscribe to receive the latest version of the handout by visiting evidencebasedbirth.com/covid19.


Research Update

Numbers Update from Johns Hopkins University

There are more than 268 million confirmed and probable cases of COVID-19 around the world, with more than 5.2 million total deaths. The U.S. has both the highest number of total cases (49 million) and the highest cases from the past 28 days (2.7 million). The other countries with highest 28-day case rates are Germany (1.4 million), the United Kingdom (1.2 million), Russia (948,043), and France (850,991).

The Johns Hopkins COVID-19 Dashboard has a counter that tracks total and 28-day vaccine doses administered around the world. There have been more than 8.3 billion vaccine doses administered, with 888 million taking place in the past 28 days. There has been a huge uptick in vaccinations worldwide over the last couple of months (over 2 million in just the last 28 days), though inequity continues to be an issue. The U.S. has now approved booster doses for all individuals 16 and older while more vulnerable populations in other countries remain unvaccinated or partially vaccinated. Additionally, while the U.S. have begun vaccinating 5 to 11-year-olds, children and adolescents are unvaccinated in most of the world.

Vaccine Approval Updates

  • On November 2, 2021, the CDC recommended Pfizer BioNTech’s pediatric COVID-19 vaccine for children ages 5 to 11. Preliminary clinical trials show the vaccine to be 91% effective at preventing infection. The most common side effect seen in children was a sore arm. Here is a link to their press release.
  • Booster shots have been recommended for vulnerable populations for a couple of months in the U.S. but, on December 9, 2021, this recommendation was extended to all people 16 years and older. Per a webinar we attended on December 1, 2021, taught by Kara Polen at the CDC, this recommendation includes pregnant and lactating people as well as those hoping to become pregnant soon (Polen, 2021). Here is link to a booster shot guide and further information from CDC.
  • Another endorsement of booster shots for this population comes from the American College of Obstetricians and Gynecologists (ACOG), who updated their Practice Advisory on December 3, 2021, recommending booster doses for pregnant and recently pregnant people. You can read the full statement here.

Omicron Variant

  • On November 26, 2021, the World Health Organization (WHO) announced a new SARS-CoV-2 Variant of Concern (VOC) named Omicron. The VOC was identified in South Africa due to an especially rapid spread of the virus, particularly among younger age groups. Thanks to the quick and accurate work of South African scientists, Omicron was identified, sequenced, reported to the WHO, and named a VOC in rapid succession (Petersen, 2021).
  • While the public health community applauds South African scientists for their swift response and willingness to make this information public right away, this scenario highlights several areas of concern. First, only 5-10% of people on the African continent (24% in South Africa) have received their first COVID-19 vaccine dose. This huge inequity in vaccine access, paired with high rates of immune suppression due to HIV (human immunodeficiency virus) in Africa, has raised concerns about the potential for high infection rates there.
  • Another concern is that abrupt travel bans to and from the African continent may cause social and economic instability. Many scientists believe that other unidentified cases of Omicron were already established in other countries before being identified in South Africa, and that travel bans are unwarranted and will not be able to contain the spread of this new VOC.
  • Genetic sequencing of Omicron shows about 50 mutations, including over 30 mutations that are on the spike protein. This is a potential cause for concern because our immune response (whether from natural infection or induced by a vaccine) depends on our antibodies’ ability to target the spike protein (Karim, 2021).
  • Limited early data about Omicron suggest that this variant is more easily transmissible though not clinically more severe (we are still awaiting further data to understand the potential severity of Omicron). In response to this information, vaccine manufacturers are working on vaccines to specifically target Omicron.
  • On December 15, 2021, President Biden’s top medical advisor, Dr. Anthony Fauci, announced preliminary research showing that a booster dose from a mRNA vaccine is likely to offer significantly higher protection against the new and highly transmissible Omicron variant, versus the two initial doses alone. Dr. Fauci emphasized that there is not a need for a specific Omicron-targeted booster shot at this time and encouraged people to become fully vaccinated/receive booster doses in light of this new VOC. You can read a summary of the press conference here.
    • This is in line with new recommendations that came out from the CDC on December 17, 2021, recommending the mRNA vaccines over the Johnson and Johnson vaccine for both boosters and initial doses. Here is a link to the CDC’s Media Statement.

Updated Study on COVID-19 Vaccination in the First Trimester

  • We received several follow-up comments and questions regarding one of the references in our Vaccines in Pregnancy Handout. The article that we cited, “Preliminary findings of mRNA COVID-19 Vaccine Safety in Pregnant Persons” by Shimabukuro et al., was originally published in the New England Journal of Medicine in April 2021.
  • Several commenters pointed out that there was missing data for study participants who were vaccinated pre-conception or in their first trimester. This discrepancy was also addressed in a letter to the editor of the New England Journal of Medicine in October (Sun, 2021). The authors subsequently issued an updated version of the article explaining that, because of the timing of the study period, follow-up interviews had not yet occurred for 905 of the participants who received their vaccines early in pregnancy or during the pre-conception period. Researchers later contacted these participants and updated Table 4 of their paper to include the outcomes of these pregnancies.
  • In summary, 1,224 study participants received at least one dose of an mRNA vaccine before conception or prior to 20 weeks of pregnancy. In this group, the early miscarriage rate was 14.1%. Once this rate was standardized by age (adjusted to include the age of the pregnant person, since older age carries a higher risk of miscarriage), the overall miscarriage rate was 12.8%. Both rates are consistent with the early miscarriage rate in the general population. A correction was published to include this new data in October 2021 (Shimabukuro, 2021).

That concludes this month’s COVID-19 update from Evidence Based Birth®. We’ll touch base with you as needed in 2022!

Sincerely,

The Evidence Based Birth® Research Team

*A note from EBB: The research on vaccines (including the research on booster doses) is rapidly changing, and new studies may be published that update some of the current evidence written about in this handout. Below is a list of resources that may be helpful to pregnant people and those trying to conceive in navigating vaccination decisions: 

COVID-19 and Pregnancy CDC Page 

NIH-How COVID-19 Affects Pregnancy 

Preg-CoV Trial Information 

References for the December 17, 2021 Update

  • Polen, Kara. (2021). Pregnant During a Pandemic: Updates on COVID-19 and Vaccination During Pregnancy. [Power Point Presentation]. COVID-19 Vaccines & Pregnancy & Lactation: What Midwives Need to Know, National Association of Certified Professional Midwives, virtual conference.
  • Karim S, Karim Q (2021). Omicron SARS-CoV-2 Variant: a new chapter in the COVID-19 pandemic. Lancet. 2021 Dec 11. Click here
  • Petersen E, Ntoumi F, Hui D, et al. (2021). Emergence of new SARS-CoV-2 Variant of Concern Omicron (B.1.1.529)-highlights Africa’s research capabilities, but exposes major knowledge gaps, inequities of vaccine distribution, inadequacies in global COVID-19 response and control efforts. Int J Infect Dis. 2022 Jan (published online Dec 1, 2021). Click here
  • Sun H (2021). On Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons [letter to the editor]. NEJM. 2021 Oct 14. Click here
  • Shimabukuro T, Kim S, Myers T, et al. (2021). Preliminary Findings of mRNA COVID-19 Vaccine Safety in Pregnant Persons. New England Journal of Medicine. 2021 Oct 14. Click here

 

Research Update for October 29, 2021

 

Hello,

Read on for some important news about a BRAND NEW, free printable handout we’ve attached to this newsletter

It’s hard to believe, but we’ve been writing COVID-19 and Pregnancy newsletters here at EBB for more than a year and a half now!

Our first newsletter went out on March 13, 2020, and at that time there were only a few small case reports on COVID-19 and pregnancy/birth. Back then, professionals and researchers had very little idea of how to prevent and treat COVID-19 infection in pregnancy. Around the same time, we began hearing reports of infected parents being separated from their newborns immediately after birth, doulas not being allowed in hospitals, high levels of anxiety, and in-person childbirth education classes being cancelled everywhere.

It’s interesting to think about how much has changed since that time. A massive amount of research has been published in the past year and a half, and one of the biggest advances in the research has been with the development, testing, and approval of vaccines for COVID-19.

This October 2021 newsletter will be a bit different because it is primarily an announcement that we’ve completed a free handout on COVID-19 vaccines in pregnancy. We’ve spent the past few months working hard on this handout, and we hope that you find it helpful.

You can download the COVID-19 Vaccine in Pregnancy PDF handout for free here.

**Feel free to share this email and/or handout with any friends, family, clients, or colleagues who might find it helpful. If you’re a birth worker or health care worker, feel free to print off the vaccine handout to share with clients or co-workers! The handout will be updated from time to time. Let people know that anyone can subscribe to receive the latest version of the handout by visiting evidencebasedbirth.com/covid19

The archive of this newsletter will also be posted on that page.

To ask a question for consideration for future newsletters, submit your question here.

Don’t forget that our COVID-19 resource & pregnancy page includes archives of these newsletters (including past Q & A’s), a sample informed consent form to refuse parent-newborn separation, a free birthing crash course, a link to find our comprehensive EBB Childbirth Class online, and other info you might find useful.

You can access that page here.


Research Update for October 29, 2021


Numbers Update from Johns Hopkins University

  • There are more than 243 million confirmed and probable cases of COVID-19 around the world, with more than 4.9 million total deaths. The U.S. has both the highest number of total cases (45 million) and the highest cases from the past 28 days (2.5 million). The other countries with highest 28-day case rates are the United Kingdom (1.1 million), Turkey (812,305), Russia (799,887), and India (510,988).
  • The Johns Hopkins COVID-19 Dashboard has a counter that tracks total and 28-day vaccine doses administered around the world. There have been more than 6.8 billion vaccine doses administered, with 689 million taking place in the past 28 days. Global vaccine inequities continue to be an issue—while the U.S. administered its first doses about 10 months ago and is now providing boosters and preparing to vaccinate children, people in many other countries are just now getting their first doses or do not yet have access.

Vaccine Approval Updates

  • On September 21, 2021, the FDA announced the Emergency Use Authorization (EUA) of booster doses of the Pfizer/BioNTech via press release. Here is a link to the full statement. The EUA includes people over 65, immunocompromised individuals, and adults living or working in high-risk environments.
  • Then, on October 20, 2021, the FDA announced the EUA of booster doses for Moderna and Johnson and Johnson vaccine recipients as well. The approval applies to the same, more vulnerable population and also allows for the mixing of vaccines, such that the booster dose may be a different brand than the primary vaccine dose(s). Here is that press release.
  • On September 20, 2021, Pfizer announced results from its phase 2/3 clinical trial in children ages five to eleven. Favorable safety and efficacy data from 2,268 participants ages five to eleven-years-old shows a robust immune response and that the vaccine is well-tolerated in children. The vaccine, which is a two-dose regimen of 10 milligrams per dose (as compared to 30 milligrams per dose in the adult version) administered 21 days apart, has initial efficacy of 90.7%. Here is a link to the press release from Pfizer.
  • Then, on October 26, 2021, the FDA’s independent advisory committee recommended approval of Pfizer/BioNTech’s COVID-19 vaccine for children ages five to eleven. This is the first step in the formal approval process and subsequent FDA and CDC meetings are scheduled in the coming days.
  • Here is an NPR link if you would like to read or listen to the United States’ plans for vaccines for kids.

Vaccine Handout from EBB

As we mentioned earlier, we have spent quite a bit of time compiling a free handout all about the research evidence on COVID-19 vaccination in pregnancy and lactation. You can download that handout here!

The handout will also be housed on our COVID-19 in Pregnancy Resource page, here. (It will be posted later today.)


This concludes the research update for October 29, 2021. We hope you found it helpful!

If you would like to submit a follow-up question for our consideration to include in upcoming newsletters, you can submit your question here.

Sincerely,

Rebecca Dekker, PhD, RN
Erin Wilson, MPH

Research Update for August 27, 2021

 

Hello,

It’s been a few months since our last COVID-19 and pregnancy newsletter. Since that time, we have been tracking new information regarding the Delta variant as well as the latest research on vaccines during pregnancy and lactation. There is not a lot of published research specific to the Delta variant and pregnancy. However, there is a lot of news circulating on this topic. We expect the amount of research on this topic to grow over the next few months.

In this edition of the newsletter, we will focus on the Delta variant in pregnancy. We discuss the available evidence on the severity of hospitalizations for pregnant people, vaccination while lactating, and the association between pre-term labor and COVID-19 infection. We also review the recent guidance issued by several professional organizations regarding pregnancy and COVID-19 vaccination. As usual, at the end of the newsletter, we will cover some questions sent to us by readers.

**Feel free to forward this email to any friends, family, clients, or colleagues who might find it helpful. If you’re a healthcare worker, feel free to print this off to share at the nurse’s station! Anyone can subscribe to receive these updates by visiting evidencebasedbirth.com/covid19

The archive of this newsletter will also be posted on that page.

Today’s questions (answered in a Q&A section at the bottom of this email) include:

  • Are the components of the COVID-19 vaccine passed through human milk?
  • Are more babies being hospitalized with COVID-19 infection? Is transmission from pregnant people to their babies happening more frequently with the Delta variant?
  • What further research is upcoming regarding pregnancy and the COVID-19 vaccine?


To ask a question for consideration for future newsletters, submit your question here.

Don’t forget that our COVID-19 resource & pregnancy page includes archives of these newsletters (including past Q & A’s), a sample informed consent form to refuse parent-newborn separation, a free birthing crash course, a link to find our comprehensive EBB Childbirth Class online, and other info you might find useful. You can access that page here.


Research Update for August 27, 2021


Numbers Update from 
Johns Hopkins University

As of August 27, 2021, there are more than 214 million confirmed and probable cases of COVID-19 around the world, with more than 4.4 million total deaths. The U.S. has both the highest number of total cases (38 million) and the highest cases from the past 28 days (3.6 million). The other countries with highest 28-day case rates are India (1 million), Iran (1 million), Brazil (837,000), and the United Kingdom (832,000).

The Johns Hopkins COVID-19 Dashboard now has a counter that tracks total and 28-day vaccine doses administered around the world. There have been more than 5 billion vaccine doses administered, with 1.1 billion taking place in the past 28 days. Global vaccine inequities continue to be an issue—while the U.S. administered its first doses 8-9 months ago and is beginning to provide boosters, people in many other countries are just now getting their first doses or do not yet have access.

Readers who live in the U.S. may find the covidestim website helpful. This epidemiology project contains state and county-level maps and graphs (using data from Johns Hopkins) that depict infection rates (per 100,000), total number of infections, the reproduction number, and percent ever infected. The graphs can be helpful for detecting after infections have peaked in a local surge (however, hospitalizations may continue to increase after a peak). The covidestim website is a joint project from researchers at Yale School of Public Health, Harvard T. H. Chan School of Public Health, and Stanford Medicine.

FDA Vaccine Approval Update

On August 23, 2021, the FDA issued full approval of Pfizer’s COVID-19 vaccine, replacing the emergency authorization that was issued in December 2020. Some researchers and public health professionals think that full approval may decrease vaccine hesitancy. In a June 2021 poll, the Kaiser Family Foundation found that 31% of unvaccinated people said they would be more likely to receive a vaccine once one receives full FDA approval. NPR also reports that full approval may make it easier for employers, school systems, and the military to issue vaccine mandates.

Research on the Delta Variant in Pregnancy

global health warning has been issued in response to a new study, carried out by the National Institute for Health Research (NIHR) and the University of Oxford, that shows increasing severity of COVID-19 infection in pregnant people hospitalized with the Delta variant-particularly in those who are unvaccinated (Vousden, 2021).

  • This study, released as a preprint version, reviewed the medical records of 3,371 pregnant people admitted to the hospital due to active COVID-19 infection from the beginning of the pandemic through July 11, 2021.During the first wave of infection, 24% of hospitalized pregnant people had moderate to severe symptoms.
  • During the Alpha variant wave, 36% of hospitalized pregnant people had moderate to severe symptoms. So far, 45% of pregnant people admitted with the Delta variant have had moderate to severe symptoms
  • In February 2021, as vaccines became more widely available for pregnant people living in the United Kingdom, vaccination status was added to the data collected for this study. Of the 742 pregnant people admitted to the hospital with COVID-19 since February 2021, 738 (99.5%) were unvaccinated. Four participants who were admitted to the hospital with COVID-19 had received 1 dose of vaccine, and none of the hospitalized pregnant patients were fully vaccinated.
  • The NIHR stated that pregnant people hospitalized with the Alpha variant were more likely to require respiratory support, develop pneumonia and be admitted to the intensive care unit (ICU) as compared to those infected during the first wave.
  • Those with the Delta variant were at an even higher increased risk for respiratory support, pneumonia, and ICU admission. So far, the rate of infants admitted to the neonatal intensive care unit (NICU) has remained relatively stable.
  • In response to this worrying rise in severity of infection for unvaccinated pregnant people, the Chief Midwifery Officer of England is urging expectant parents to receive COVID-19 vaccination as soon as possible.


New Research on Vaccination during Pregnancy


An upcoming article, to be published in the American Journal of Obstetrics and Gynecology, followed 1,328 pregnant people who gave birth at St. George’s University Hospitals in London from March 2021 through July 2021. The purpose of this study was to evaluate vaccine safety and outcomes data during pregnancy. Please note that because this data is not officially published yet, there may be slight changes because of peer review or other updates (Blakeway, 2021).

  • Out of the 1,328 people who gave birth, 141 had received at least one dose of the vaccine and 1,187 were completely unvaccinated. We do not have data on how many participants were fully vaccinated. Almost all vaccinated people (85.8%) received their vaccine in the third trimester of pregnancy. Most (90.8%) received an mRNA vaccine (Moderna or Pfizer), and 9.2% received a viral vector vaccine (Astra Zeneca). All three vaccines are two-dose regimens.
  • The vaccinated and unvaccinated groups had similar rates of adverse outcomes such as stillbirth, fetal abnormalities, postpartum hemorrhage, cesarean section, and neonatal or intensive care unit admission.
  • Younger study participants were less likely to have received the vaccine, as well as those of lower socio-economic status and non-white ethnicity. There was a higher rate of vaccination in participants with Type I or Type II diabetes, possibly because this group became eligible for vaccination earlier in the study. The researchers concluded that this study has important implications for improving vaccine uptake by identifying facilitators and barriers to vaccination (AJOG).
  • One limitation of this study is that not everyone enrolled was eligible to receive a vaccine until June 2021 (some participants became eligible in April, and others in May). Another, related limitation is that the median time from vaccination to giving birth was only about one month—most vaccines were given in the third trimester of pregnancy. Additionally, those that had been fully vaccinated before pregnancy were excluded from the study. It is also important to note that this is a small sample size of pregnant, vaccinated people (141 total). More research on first and second trimester vaccination, longer-term outcomes following vaccination at any time in pregnancy, and a larger sample size is needed for continued study.
  • Note from EBB: For more information on vaccination in pregnancy, please see below:
    • We discussed the v-safe vaccine pregnancy registry at length in the May 25, 2021, edition of this newsletter, available at our COVID-19 resource page here.
    • As of August 23, 2021, the CDC notes that 153,400 people in the U.S. indicated they were pregnant in the v-safe app at the time of their COVID-19 vaccination, and more than 5,000 had enrolled in the official v-safe vaccine pregnancy registry.
    • We’ve seen some people on social media become confused by the difference between VAERS (a reporting system that is only used by people who experience potential adverse effects; although it can be helpful for identifying potential safety issues, it cannot be used to determine risk/benefit percentages), v-safe (a health checker app) and the v-safe vaccine pregnancy registry (a study that people are enrolled in after they are vaccinated during pregnancy, and has the capability to determine safety, potential benefits, and the absolute risk of adverse effects). The first study from the v-safe vaccine pregnancy registry was published in the New England Journal of Medicine (and discussed in our May 2021 newsletter).
    • To learn more about v-safe and the v-safe vaccine pregnancy registry, visit the CDC website here.
    • To read the newest pre-print analysis of the CDC v-safe pregnancy registry (that includes study data from more than 2,500 people vaccinated before 20 weeks of pregnancy), click here.

New Research on Pre-term birth and COVID-19 infection

A study published July 30, 2021, in Lancet Regional Health- Americas, looks at the association between COVID-19 infection and pre-term birth (Karasek, 2021).

  • In this study, researchers analyzed the California Vital Statistics birth certificate records of 240,157 live births that occurred in California between July 2020 and January 2021. In this sample, 3.7% of participants had a COVID-19 diagnosis in pregnancy. COVID-19 diagnosis was defined as either confirmed or probable. Confirmed cases were verified by a CDC lab, and probable cases were verified by a state or local lab. For analysis purposes, researchers divided pre-term birth into these categories: very pre-term birth (VPTB, or less than 32 weeks pregnant), pre-term birth (PTB, or less than 37 weeks pregnant), and early term birth (37 to 38 weeks and 6 days pregnant).
  • Researchers found a 60% relative risk increase in very pre-term birth in participants with a COVID-19 diagnosis. Additionally, there was a 40% relative risk increase in pre-term birth, and a 10% relative risk increase in early term birth in participants with a COVID-19 diagnosis.
  • Pregnant people with a COVID-19 diagnosis as well as high blood pressure, diabetes, and/or a BMI greater than 30, had even slightly higher increased rates in the pre-term and very pre-term birth categories compared to people with COVID-19 who did not have these factors.
  • In the study population, COVID-19 diagnosis rates increased across all race/ethnicity groups but was disproportionately higher among Latinx, American Indian/Alaska Native, and Native Hawaiian/Pacific Islander birthing people as well as among people with public insurance. The most striking disparity was in the Latinx study population, who represented 47% percent of the pregnant participants but 72% of the positive COVID-19 cases.
  • Researchers concluded that it is important to continue this work “to understand the full impact of COVID-19 diagnosis on pre-term birth and to address the increased prevalence of COVID-19 diagnosis in groups already facing inequities in birth outcomes as a result of structural racism” (The Lancet).

 

Professional Guidance

Over the past few weeks, several major organizations have revised their guidance to suggest that all pregnant people get vaccinated against COVID-19. These recommendations are in response to evidence that the Delta variant is causing more severe disease in pregnant people, as well as increasing data showing the safety and efficacy of COVID-19 vaccines in pregnancy and lactation.

  • On July 30, 2021, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) put out a statement recommending COVID-19 vaccination for pregnant individuals. In a news release, they stated that their “recommendation in support of vaccination during pregnancy reflect evidence demonstrating the safe use of COVID-19 vaccines during pregnancy from tens of thousands of reporting individuals over the last several months, as well as the current low vaccination rates and concerning increase in cases.” You can read the full statement here.
  • The CDC also released updated guidance on August 11, 2021. This recommendation comes after a new, pre-print data analysis of the CDC’s v-safe pregnancy registry. In this, the medical records of nearly 2500 people who received an mRNA COVID-19 vaccine before 20 weeks in pregnancy were reviewed. The study found no increase in the rate of miscarriage in people who received the vaccine as compared to the general population (the miscarriage rate of those studied was 13%, and the national average is 11-16%). The research is available in pre-print form here.
  • Previous data from the CDC’s monitoring systems did not find any safety concerns for people vaccinated later in pregnancy. Per the CDC, the combination of this data, combined with the known severe risks of COVID-19 infection in pregnancy show that the benefits of vaccination outweigh the risks. You can read the CDC’s press release here.
  • On August 12, 2021, the American College of Nurse Midwives (ACNM), along with many other obstetric care provider groups, endorsed a joint ‘Statement of Strong Medical Consensus for Vaccination of Pregnant Individuals Against COVID-19’. The statement encourages vaccination considering the increasing severity of infection for pregnant people with the Delta variant. It also focuses on the increasing evidence of vaccine safety for pregnant people as well as for those wanting to conceive. You can read the statement from ACNM here.

 

Links to Other Research you may find Interesting:

  • The CDC published a report on new COVID-19 cases and hospitalizations in New York, by vaccination status, from May to July 2021. You can read it here. A similar report for Los Angeles County is available here.
  • A research letter titled “Short-term Reactions Among Pregnant and Lactating Individuals in the First Wave of the COVID-19 Vaccine Rollout” was published in JAMA Network Open. You can access the letter here.
  • A pre-publication research article titled, “SARS-CoV-2 Antibodies in Breast Milk After Vaccination” is available in Pediatrics, the official journal of the American Academy of Pediatrics. You can access that study here.

 


Q & A Section

Question: Are the COVID-19 vaccine components passed through human milk?

A new, small study from researchers at the University of California San Francisco (Golan, 2021) offers the first direct data of whether vaccine components can be passed to infants through human milk. In this study, researchers examined milk samples from seven lactating individuals prior to and at various times up to 48 hours post COVID-19 vaccination. All seven participants received mRNA vaccines (Moderna or Pfizer). There were no components of the vaccine present in any of the samples of milk. Although this study sample was small, it is typical for biological sample studies to be comprised of small samples (due to the cost and intensity of repeatedly collecting and analyzing biological samples). We will keep our eyes open for further studies on this topic.

In our May 2021 newsletter, we reviewed a study published in JAMA that shows the successful transfer of antibodies from participants to their infants through cord blood and human milk samples. You can find our May 2021 newsletter on our COVID-19 resource page here.

So, although the first research on this topic found that vaccine components were not directly transferring through human milk, there is evidence from prior research that babies are receiving some immunity from vaccinated, lactating parents. More research is coming on the best timing to vaccinate someone in pregnancy to optimize immunity for infants. Further down in this Q & A we will talk about the upcoming Preg-CoV study, which will analyze this and other questions about vaccination in pregnancy.

Question: Are more infants being hospitalized with COVID-19 infection? Is transmission from pregnant people to their babies happening more frequently with the Delta variant?

We could not find any evidence yet that transmission from pregnant people to their newborns (i.e. perinatal transmission in utero or during birth) is increasing with the Delta variant. There is also not published research indicating an increased severity for young children. Rather, it is thought that the increase in hospitalizations in children (and the reports of strained pediatric ICU units) is due to the increased transmissibility of the Delta variant as well as the virus having a bigger impact on unvaccinated populations, which includes young children (NPR). It’s thought that the higher transmission leads to more children being infected, so there is a bigger pool of children who could eventually develop symptoms requiring hospitalization.

In contrast, as mentioned at the beginning of this newsletter, there is evidence that the Delta variant is causing more severe disease in pregnant people. Hospital staff, such as those at the University of Alabama at Birmingham [trigger warning: maternal mortality], have been interviewed about the increased number of pregnant women being admitted to ICUs in the U.S.

Question: What new research is upcoming regarding pregnancy and vaccines?

A new study in the United Kingdom called “Preg-CoV” will be the first randomized, controlled COVID-19 vaccination trial specific to pregnancy. Participants will be randomly assigned to either receive the vaccine pre-pregnancy, or in the first, second, or third trimester. For the first phase of the study, the team plans to recruit 600 participants across 13 sites in England. This research will help determine the best gap between doses, as well as the optimal timing for vaccination in pregnancy.

Researchers will also explore any potential benefits or side effects on infants after they are born. Thus far in the pandemic, pregnant people have been excluded from randomized, controlled vaccine trials. This research will provide information specific to vaccination in pregnancy in much greater detail (Health Policy Watch).


This concludes the research update for August 27, 2021. We hope you found it helpful!

If you would like to submit a follow-up question for our consideration to include in upcoming newsletters, you can submit your question here.

Sincerely,

The EBB Research Team

Research Update for May 25, 2021

It’s been several months since our last COVID-19 and pregnancy newsletter, and since then we’ve been tracking and collecting the information on the COVID-19 vaccine in pregnancy.

In this special edition of the Evidence Based Birth® COVID-19 Newsletter, we focus on the new information coming out about pregnancy and the COVID-19 vaccine. We share key information about preliminary findings of mRNA vaccine COVID-19 safety in pregnancy, the first study to examine the impact of the COVID-19 vaccines on the placenta, and research on vaccine response in pregnancy and lactation. Finally, we share links to professional guidelines on the vaccine in pregnancy and lactation.

We know that the COVID-19 vaccine is controversial. Here at EBB, we are not taking a stance on particular vaccines—we’re simply describing the research findings on this topic. We hope this information will be helpful, especially because many people are considering whether to receive the vaccine during pregnancy.

**Feel free to forward this email to any friends, family, clients, or colleagues who might find it helpful. If you’re a healthcare worker, feel free to print this off to share at the nurse’s station! Anyone can subscribe to receive these updates by visiting evidencebasedbirth.com/covid19

The archive of this newsletter will also be posted on that page.

Today’s questions (answered in a Q&A section at the bottom of this email) include:

  • Do the vaccines have any effect on fertility?
  • What strategies in the U.S. are helping to close racial and income gaps in vaccination rates?
  • What did the researchers find in the adolescent trials?

To ask a question for consideration for future newsletters, submit your question here.

Don’t forget that our COVID-19 resource & pregnancy page includes archives of these newsletters (including past Q & A’s), a sample informed consent form to refuse parent-newborn separation, a free birthing crash course, a link to find our comprehensive EBB Childbirth Class online, and other info you might find useful. You can access that page here.

Research Update for May 25, 2021

Numbers Update from Johns Hopkins University 

As of May 25, 2021, there are more than 167 million confirmed and probable cases of COVID-19 around the world. The highest number of total cases is still in the U.S. (33 million) followed by India (27 million), Brazil (16 million), France (5.6 million), Turkey (5.2 million), Russia (4.9 million), and the United Kingdom (4.5 million). In our last research update in late March 2021, we shared at that time that there were 66 million cases in the world and 15 million in the U.S. So, the numbers have nearly tripled worldwide but only doubled in the U.S., reflecting the slowdown in U.S. cases.

Our hearts are with India as they are amid the current epicenter of the pandemic. Here’s a list of places you can donate to help India during its COVID-19 surge. These organizations fund and provide medical supplies like oxygen and PPE, and some focus on serving India’s marginalized communities (e.g., India’s Muslim community, children in shelters, and transgender Indians).

Research on Receiving the Vaccine during Pregnancy and Lactation

Preliminary findings of mRNA vaccine COVID-19 safety in pregnant people

  • Since pregnant people were not included in the clinical trials, there are limited safety data for mRNA COVID-19 vaccines during pregnancy. However, many pregnant people in the general population have received these vaccines outside of clinical trials, and researchers can assess safety outcomes in this group.
  • A study published April 21 in the New England Journal of Medicine found no evidence of safety concerns among pregnant people who received the mRNA vaccines (Shimabukuro et al. 2021).
  • The study used data from three U.S. vaccine safety monitoring systems: the “v-safe after vaccination health checker” surveillance system (a voluntary smartphone app, discussed in our March 30 research update), the v-safe pregnancy registry (a telephone-based survey that collects detailed info), and the Vaccine Adverse Event Reporting System (VAERS).
  • Between December 14, 2020 and February 28, 2021, a total of 35,691 v-safe participants identified as pregnant. Most people in the sample (about 75%) identified as non-Hispanic white.
  • Vaccine-related side effects were mostly similar between pregnant and nonpregnant v-safe participants; however, pregnant participants were more likely to report injection site pain and less likely to report headache, myalgia (muscle pain), chills, and fever.
  • Out of nearly 4,000 participants in the v-safe pregnancy registry, 827 had a completed pregnancy (86% had a live birth, 13% had a miscarriage, 0.1% had a stillbirth, and around 1% had an induced abortion or ectopic pregnancy).
  • Most of the participants who had a completed live birth had received their mRNA COVID-19 vaccines in the third trimester. There were no newborn deaths. About 9% of the babies were born preterm and about 3% were small for gestational age.
  • During the study period, the VAERS processed 221 reports of adverse events involving COVID-19 vaccination among pregnant people. About 30% of these adverse events were considered pregnancy or newborn-related. The most frequently reported pregnancy or newborn-related adverse events were miscarriage (37 in the first trimester, 2 in the second trimester, and 7 unknown or not reported), followed by stillbirth, premature rupture of membranes, and vaginal bleeding, with 3 reports for each. No congenital anomalies were reported to the VAERS, a requirement under the vaccine emergency use authorizations (EUAs).
  • Although the researchers couldn’t directly compare vaccinated pregnant people to pregnant people who did not receive the COVID-19 vaccine, the rates of adverse events appear to be similar to the rates in studies of pregnant people before the pandemic. In other words, there is no evidence to date that COVID-19 vaccination during pregnancy increases the risk of any of these adverse events. For example, 13% of pregnant people who received the vaccine experienced a miscarriage (pregnancy loss before 20 weeks of pregnancy). The published rate of miscarriage in studies before the pandemic is 10 to 26% (Dugas and Slane, 2021).
  • Importantly, the v-safe pregnancy registry does not yet include anyone who was vaccinated early in pregnancy and then had a live birth. So, although these preliminary findings are reassuring, there is still very little data on COVID-19 vaccination in the first trimester; follow-up is ongoing.

The impact of the COVID-19 vaccines on the placenta

  • The first study to examine the impact of the COVID vaccines on the placenta was recently published (Shanes et al. 2021).
  • Growing evidence shows the increased severity of COVID-19 for pregnant people, and a study from May 2020 found the placentas of those who tested positive for the virus to have significantly higher rates of placental injury (abnormal blood flow between mother and baby in utero), compared to a control group (Shanes, Mithal, Otero et al. 2020). This new study in 2021, by many of the same authors, is the first to examine if the risk of placental injury is also elevated for individuals who have taken the COVID-19 vaccine.
  • The study includes 84 vaccinated patients and a control group of 116 unvaccinated patients, all between the ages of 30 and 37, and who gave birth at Prentice Women’s Hospital in Chicago. Most patients had received either Moderna or Pfizer vaccines during their third trimester.
  • Patients’ placentas were examined after birth, especially looking for abnormal blood flow between parent and fetus or for problems with fetal blood flow.
  • The results showed no increased likelihood of placental abnormalities from having taken COVID-19 vaccines in the third trimester. Compared to the increased risk for placental injury from contracting COVID-19, the new data suggest that the vaccine may be protective against this type of risk to the placenta.
  • These results are limited to a non-random sample, with possible baseline differences between the groups of vaccinated and unvaccinated individuals.
  • In the past, some members of our audience have complained that these types of studies that we are reporting are too small. It’s important to point out that biological studies (where biological tissues are studied) often have smaller samples than other types of studies because they’re much more time-consuming and expensive to conduct. So, a biological study of placentas from 84 vaccinated and 116 unvaccinated participants is actually a pretty decent sample size. However, to study a wide range of rarer placental abnormalities, a larger number of participants will be needed.
  • There is still no evidence on the placental impact from COVID-19 vaccination in the first or second trimester of pregnancy.

New research on vaccine response in pregnancy and lactation

  • On February 5, 2021, the first known case of an infant with antibodies to SARS-CoV-2 after maternal vaccination was posted on a preprint server (Gilbert and Rudnick, 2021). Then, in March, a study published in AJOG provided the first cohort data on maternal antibody response to COVID-19 vaccination. (Gray et al. 2021). We discussed the details of these studies in our research update from March 30, 2021, which you can access here on our COVID-19 resource & pregnancy page.
  • We now have more evidence on vaccine response in pregnancy and lactation.
  • In a study published May 13, 2021, in JAMA, researchers from Beth Israel Deaconess Medical Center studied the immune responses of a cohort of 103 individuals of child-bearing age who received either of the COVID-19 mRNA vaccines (Moderna or Pfizer). Of this group of 103 people, 30 were pregnant and 16 were lactating. The study group also included 28 unvaccinated people with confirmed COVID-19 infection. (Collier et. al, 2021).
  • All vaccinated study participants (both pregnant and non-pregnant) developed immune responses against COVID-19 and SARS-COV-2 variants of concern. Antibodies from the vaccine were present in the cord blood and human milk. Also of significance, the antibody response was more robust in people who had the vaccine than it was in the study participants who were not vaccinated but had previous COVID-19 infection.
  • This research suggests benefit from vaccination in pregnant people. This is significant because, while we know that COVID-19 infection in pregnancy carries an increased risk of morbidity and mortality, thus far pregnant people have been excluded from phase 3 vaccine trials.
  • There are some limitations of this study that should also be considered. First, the sample size is small (although as we mentioned in the above section, studies that include biological samples—such as cord blood—are usually smaller because of the expense and time involved in collecting and testing the samples). Second, this is a convenience sample rather than a randomized, placebo-controlled clinical trial. Third, while the researchers have demonstrated an immune response and the transfer of antibodies from pregnant person to baby via cord blood and human milk, this does not prove or disprove immunity in babies of vaccinated parents. More research needs to be done to make this determination.
  • Per the lead author Ai-ris Y. Collier, MD, “future research should focus on determining the timing of vaccination that optimizes delivery of antibodies through the placenta and breast milk to newborns.”

Professional Guidelines

The Royal College of Obstetricians and Gynecologists (RCOG) in the U.K. has an excellent, recently updated Q&A page on COVID-19 vaccines, pregnancy, and breastfeeding (May 14, 2021). They share the latest advice from the Joint Committee on Vaccination and Immunisation (JCVI) that “COVID-19 vaccines should be offered to pregnant women at the same time as the rest of the population, based on their age and clinical risk group.” The Royal College of Midwives’ page on COVID-19 vaccines and pregnancy also cites the JCVI advice.

The U.S. Centers for Disease Control and Prevention (CDC) states that getting vaccinated is a personal choice, and lactating people and pregnant people can receive a COVID-19 vaccine if they desire (May 14, 2021).

In the U.S., the American College of Obstetricians and Gynecologists (ACOG) recommends that pregnant individuals have access to COVID-19 vaccines and that lactating individuals be offered the vaccine similar to non-lactating individuals (April 28, 2021). They also state, “Pregnant patients who decline vaccination should be supported in their decision.”

On April 29, 2021, the U.S. Society for Maternal Fetal Medicine (SMFM) updated their guidance on “Provider Considerations for Engaging in COVID-19 Vaccine Counseling With Pregnant and Lactating Patients.” They strongly recommend that “pregnant and lactating people have access to the COVID-19 vaccines and that they engage in a discussion about potential benefits and unknown risks with their healthcare providers regarding receipt of the vaccine.”

The Society of Obstetricians and Gynecologists of Canada (SOGC) released a statement on COVID-19 vaccination and pregnancy on December 18, 2020 and reaffirmed it on May 4, 2021. They affirm, “Pregnant individuals should be offered vaccination at any time during pregnancy or while breastfeeding if no contraindications exist.”

The World Health Organization’s (WHO) Strategic Advisory Group of Experts on Immunization policy recommendations regarding the Pfizer BioNTech COVID-19 vaccine were last updated on April 20, 2021. They say that vaccination can be offered to a lactating person if they are part of a group recommended for vaccination. Regarding pregnancy, the WHO recommends, “Pregnant women may receive the vaccine if the benefit of vaccinating a pregnant woman outweighs the potential vaccine risks. For this reason, pregnant women at high risk of exposure to SARS-CoV-2 (e.g. health workers) or who have comorbidities which add to their risk of severe disease, may be vaccinated in consultation with their health care provider.”

Q & A Section

Question: Do the vaccines have any effect on fertility?

There has been no documented negative effect on fertility or pregnancy from the COVID-19 vaccines to date. Several vaccinated individuals from clinical trials became pregnant through the course of the study, so we know that blanket infertility from the vaccines is not possible. Fertility was not specifically studied in trials; however, no loss of fertility was observed in animal trials, nor has an increase in human infertility been reported in any monitoring and data collection efforts. In the United States, ACOG released a statement stating that “loss of fertility is scientifically unlikely.”

That said, there has been much online debate, questions and concern around this topic, including in parenting groups on social media. The source of most concerns can be traced back to December 2020, when German doctor Wolfgang Wodarg and a former Pfizer employee wrote a letter to the European Medicines Agency. They had noticed genetic sequencing similarities between the SARS-CoV-2 spike protein and another protein (Syncytin-1) that helps keep the placenta attached to the uterus in pregnancy.

They asked to delay the Pfizer/BioNTech approval to be sure the vaccine would not cause the body to attack its own placenta proteins, while targeting the intended spike protein. Other researchers have since confirmed that the SARS-CoV-2 spike protein and Syncytin-1 protein are not similar enough to cause harm. This is further confirmed by results from the study reviewed above (Shanes et al.) that showed no increased likelihood of placental injury after vaccination in late pregnancy.

For those concerned about the small sample size of the Shanes et al. study, the Mayo Clinic also explains that antibodies developed from the vaccine are the same as those from contracting the disease. If these antibodies, meant to target the spike protein, also had a negative impact on the placenta, a rise in miscarriages and infertility would be expected across the population of all those who tested positive for COVID-19 in the last 15 months. Such a rise has not been found.

We hope to see research in the future including individuals who gave birth after developing antibodies (either from natural infection or vaccination) in the preconception period or in early pregnancy. This would confirm the fertility in two groups that have no scientific reasons for concern yet have not been specifically studied.

Question: What strategies in the U.S. are helping to close racial and income gaps in vaccination rates?

Black leaders in health care have started clarifying an important difference between “vaccine hesitancy” and “vaccine inaccessibility,” especially for people of color, the elderly, and individuals with disability, low English skills, no internet access, multiple jobs, and those living in rural areas. The initial conversations about “vaccine hesitancy” tried to explain disparities in vaccination rates by telling critical histories of medical abuse – from Tuskegee syphilis experiments and gynecological experimentation on enslaved women like Anarcha, to ongoing realities like the Flint water crisis, sterilization without informed consent, and racism and obstetric violence in pregnancy and childbirth.

Sharelle Barber, a social epidemiologist at Drexel University, cautions however against a narrative assuming all Black people are opposed to vaccines. “That then puts the blame on individuals and communities as opposed to actually planning for action and equity,” says Barber. This raises the possibility of incorrectly thinking that “If Black individuals aren’t gonna want to take it, we don’t have to actually allocate resources to actually improve access.”

Community-based groups like the Black Doctors COVID-19 Consortium, led by Dr. Ala Stanford in Philadelphia are making waves and raising funds for their unique approach of bringing vaccines to the people. Praised by President Biden as the “Community Corps,” groups around the country have started door knocking and bringing vaccines to homes, churches, workplaces, public parks, and parking lots. In areas with high rates of unvaccinated people, simple gestures make a difference, such as taking walk-ins, staying open 24 hours, removing residency requirements, taking reservations by phone, and asking National Guard staff to wear plainclothes instead of military uniforms.

Uber and Lyft are now offering free rides to vaccination sites until July 4th, and the Biden Administration has planned for $6 billion to health centers serving low-income populations, community outreach workers to arrange transportation and childcare, and tax breaks to businesses that give employees paid time off to be vaccinated.

Research also shows that health messages are more trusted by Black and Latinx patients, when delivered by doctors that share their racial identity. There are excellent resources online with Black doctors addressing common vaccine questions and concerns.

Finally, Black leaders have also emphasized that science – when used appropriately – is in line with a rich Black and African history of medical and scientific innovation. This includes the first smallpox vaccine, introduced to U.S colonists in 1716 by an enslaved African named Onesimus.

Question: What did the researchers find in the adolescent trials?

On May 10, the FDA announced in a news release that it has expanded its emergency use authorization of the Pfizer COVID-19 vaccine for adolescents aged 12-15 years. This is an extension of the previous emergency use authorization for teenagers aged 16-17.

The dosing and dosage are the same for adolescents and adults, which is 2 doses given 3 weeks apart. The vaccine should not be given to anyone with a history of a severe allergic reaction to any component of the vaccine.

The on-going safety data to support the emergency use authorization for adolescents comes from a randomized, placebo-controlled clinical trial of 2,600 participants aged 12-15 in the United States. Of this group, about half received the vaccine and half received the placebo. Greater than 50% of the total study population was followed for at least two months post vaccine.

As with adult and older teenage populations who received the vaccine, the most common side effects were pain at the injection site, tiredness, headache, chills, muscle pain, fever, and joint pain.

It’s important to point out that the vaccination of young adolescents raises concerns about equity in global vaccine access. While the U.S. vaccinates its teens, other countries are not able to vaccinate their highest-risk adults. The United States currently has a surplus of vaccine (with some states resorting to hosting cash lotteries to convince more people to get the vaccine), while only 0.3% of all vaccines administered worldwide have gone to low-income countries (Stone, 2021).

With countries like Nepal now experiencing 50% positivity rates, help is needed to lessen the strain on these fragile medical systems and to stop the spread of new strains of the virus. As infectious disease specialist Dr. Stone put it, “Viruses do not recognize borders. No one is safe until we all are.”

This concludes the research update for May 25, 2021. We hope you found it helpful! We do not have a specific date for our next COVID-19 research update, but we plan on releasing another update in the fall.  

If you would like to submit a follow-up question for our consideration to include in upcoming newsletters, you can submit your question here.

Sincerely,

The EBB Research Team

 

References

Collier AY, McMahan K, Yu J, et al. (2021). Immunogenicity of COVID-19 mRNA Vaccines in Pregnant and Lactating Women. JAMA. Published online May 13, 2021. Click here.

Dugas C and Slane VH (2021). Miscarriage. In: StatPearls. Treasure Island, FL: StatPearls Publishing, 2021. Click here.

Gilbert P. and Rudnick C. (2021). Newborn antibodies to SARS-CoV-2 detected in cord blood after maternal vaccination. medRxiv [preprint]. Click here.

Gray K., Bordt E., Atyeo C., et al. (2021). COVID-19 vaccine response in pregnant and lactating women: a cohort study. AJOG. 2021 Mar 25 [Articles in press]. Click here. 

Shanes ED, Otero S, Mithal LB, et al. (2021). Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccination in Pregnancy: Measures of Immunity and Placental Histopathology. Obstet Gynecol. 2021 May 11. Click here.

Shanes, E. D., Mithal, L. B., Otero, S., Azad, H. A., Miller, E. S., & Goldstein, J. A. (2020). Placental Pathology in COVID-19. American journal of clinical pathology154(1), 23–32. Click here.

Shimabukuro TT, Kim SY, Myers TR; CDC v-safe COVID-19 Pregnancy Registry Team (2021). Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons. N Engl J Med. 2021 Apr 21. Click here.

Research Update for March 30, 2021

In this edition of the Evidence Based Birth® COVID-19 Newsletter, we provide key details from new research on COVID-19 and pregnancy. We’ll be discussing findings from the v-safe COVID-19 Vaccine Pregnancy Registry, evidence on the COVID-19 vaccine response in pregnant and lactating people, the first update of the Allotey et al. “living systematic review,” a systematic review of guidelines on COVID-19 and pregnancy, and links to other interesting research that has come out over the last few weeks.

 Today’s questions (answered in a Q&A section at the bottom of this email) include:

  •  I plan to get the COVID-19 vaccine even though I am currently lactating. Will I need to pump and dump for a while after getting the vaccine?
  • How does access to COVID-19 vaccination vary across the world?
  • Could you share more info on the 1-shot COVID-19 vaccine?

 To ask a question for consideration for future newsletters, submit your question here.

 **Feel free to forward this email to any friends, family, clients, or colleagues who might find it helpful. If you’re a healthcare worker, feel free to print this off to share at the nurse’s station! Anyone can subscribe to receive these updates by visiting evidencebasedbirth.com/covid19

 The archive of this newsletter will also be posted on that page.

 Don’t forget that our COVID-19 resource & pregnancy page includes archives of these newsletters (including past Q & A’s), a sample informed consent form to refuse mother-newborn separation, our virtual doula directory, a free birthing crash course, a link to find our comprehensive EBB Childbirth Class online, and other info you might find useful. You can access that page here.

 Research Update for March 30, 2021

 Numbers Update from Johns Hopkins University

 As of March 30, 2021, there are over 127 million confirmed and probable cases of COVID-19 around the world. The highest number of cases is still in the U.S. (over 30 million), followed by Brazil, India, France, Russia, the United Kingdom, Italy, Spain, Turkey, and Germany.

 The v-safe COVID-19 Vaccine Pregnancy Registry

 Note from EBB: Pregnant and lactating people have been excluded from all of the vaccine trials to date. Data from animal studies and a small number of pregnant people who were inadvertently enrolled in the vaccine trials have not shown harmful effects. So, there have been no safety concerns or “red flags,” but the evidence is limited. More data will be available in the coming weeks and months.

  • The v-safe pregnancy registry is one of several vaccine monitoring systems that the U.S. CDC and FDA have put in place to capture info about COVID-19 vaccination during pregnancy.
  • As of March 22, over 60,000 people have self-reported they were pregnant at the time of vaccination to CDC’s v-safe After Vaccination Health Checker. Nearly 4,000 of these pregnant vaccine recipients have been enrolled in the v-safe pregnancy registry.
  • Everyone in the v-safe registry was either pregnant at the time of receiving the vaccine or within 30 days of vaccination. Participants are contacted once per trimester, after birth, and when the infant is 3 months old. Phone surveys are conducted and maternal and infant medical records are reviewed. The outcomes of interest include miscarriage, stillbirth, pregnancy complications, maternal ICU admission, poor birth outcomes, newborn death, infant hospitalizations, and birth defects.
  • The CDC will present data from the v-safe registry at Advisory Committee on Immunization Practices (ACIP) meetings. The next ACIP meeting is planned for May 5. You can view the most recent ACIP meeting presentation slides here. On March 1, Dr. T Shimabukuro gave a covid-19 vaccine safety update that included a report on the v-safe pregnancy registry. The report was based on 1,815 participants who had received either the Pfizer or the Moderna vaccines; there were 275 completed pregnancies, including 232 live births.
  • They compared rates of pregnancy outcomes, pregnancy complications, and newborn outcomes in the v-safe registry participants to estimates of background rates in the population. So far, there is no evidence of excess adverse events with vaccination. The U.S. CDC report concluded, “No unexpected pregnant or infant outcomes have been observed related to COVID-19 vaccination during pregnancy.”

 COVID-19 vaccine response in pregnant and lactating people

 On February 5, the first known case of an infant with antibodies to SARS-CoV-2 after maternal vaccination was posted on a preprint server (Gilbert and Rudnick, 2021). Preprints report the very latest medical research, but since they have not yet been peer-reviewed, they should not be used to guide clinical practice.

  • In this case report, a healthy full-term infant was born after a spontaneous vaginal birth to a mother who had received a single dose of the Moderna mRNA vaccine for SARS-CoV-2 three weeks prior to giving birth (at 36 weeks, 3 days). Researchers were able to detect antibodies (IgG) in cord blood.
  • This finding was not surprising; maternal influenza and TDaP vaccination is known to provide newborn protection by placental passage of antibodies.
  • Note from EBB: Although there appears to be infection risk reduction for the newborn with maternal vaccination, we still do not know to what extent newborns born to vaccinated mothers remain at risk of infection. We also do not know how long protection could be expected to last.
  • Another study was published in AJOG on March 25, 2021 (Gray et al. 2021). This study provides the first cohort data on maternal antibody response to COVID-19 vaccination.
  • This prospective cohort study compared vaccine response in 131 reproductive-age vaccine recipients (84 pregnant, 31 lactating, and 16 non-pregnant). Equivalent numbers of participants received the Pfizer/BioNTech and Moderna vaccines. Of pregnant participants, the average gestational age at first vaccine dose was 23.2 weeks; 13% received their first vaccine dose in the first trimester, 46% in the second trimester, and 40% in the third trimester.
  • They detected a robust immune response in pregnant and lactating individuals, comparable to non-pregnant controls. Vaccine-induced maternal antibody titers did not differ by trimester of vaccination. Immune protection from vaccine-generated antibodies transferred to newborns via placenta and human milk (antibodies were detected in umbilical cord blood and human milk). Interestingly, the vaccine generated higher antibody levels than seen after natural SARS-CoV-2 infection in pregnancy.
  • You can read more coverage of this study in a Harvard news piece here.

 First update of the Allotey et al. living systematic review and meta-analysis

 **Content warning: Statistics related to maternal mortality**

  • In our research update from September 8, 2020 we shared findings from the original Allotey et al. living systematic review and meta-analysis that was published in the BMJ on September 1, 2020. You can access an archive of that newsletter on our COVID-19 resource page here. The reason it is called a “living systematic review” is because the authors plan to update it regularly for up to two years after the original publication to reflect emerging evidence. Since they published the first version of their review, over 150 reviews have been published on COVID-19 and pregnancy. These reviews vary widely in quality and even the most rigorous reviews become quickly outdated. At EBB, we’ve been tracking this high-quality review. It comes from a research collaborative (called the PregCOV-19 Living Systematic Review Consortium) which coordinated with the World Health Organization (WHO), the Cochrane Centre, and other key groups to conduct a first-rate systematic review in a framework that allows them to quickly update the findings as new data emerge.
  • The original review included 77 studies. Of these, 26 were from the United States (U.S.), 24 from China, seven from Italy, six from Spain, three each from the United Kingdom (U.K.) and France, and one each from Belgium, Brazil, Denmark, Israel, Japan, Mexico, the Netherlands, and Portugal.
  • Update 1 was published in the BMJ on March 10, 2021. This update includes 192 studies with over 64,000 pregnant and recently pregnant people. So, this new version added 115 new studies to the review. Of the 192 studies, 58 were from the United States; 31 from China; 17 from Italy; 15 from Spain; eight from Turkey; seven each from the U.K. and India; five each from Brazil, France, and Mexico; three each from Iran and Portugal; two each from Belgium, Denmark, the Netherlands, Peru, and Sweden; and one each from Bangladesh, Chile, Estonia, Israel, Japan, Germany, Ireland, Kuwait, Pakistan, Qatar, Romania, Russia, and Switzerland.
  • Findings: Compared to the original review, the proportion of pregnant and recently pregnant people with COVID-19 remained the same (there was no difference in the prevalence of COVID-19). Overall, about 1 in 10 pregnant or recently pregnant people who were admitted to the hospital for any reason (i.e. illness, childbirth) were diagnosed as having suspected or confirmed COVID-19. Note that these findings only apply to pregnant people admitted to a hospital at some point during pregnancy or postpartum. Also, hospitals used different screening strategies, with some testing only people with symptoms and others testing everyone upon admission (universal testing).
  • The most common clinical signs/symptoms of COVID-19 in pregnancy were fever (40%) and cough (41%). Pregnant and recently pregnant people with COVID-19 were significantly less likely to have any symptoms compared to non-pregnant women of the same age. They were less likely to report symptoms of fever, muscle pain, or shortness of breath.
  • Pregnant people continued to be at increased risk of severe COVID-19, although the absolute rates of poor outcomes were low.
  • Compared to non-pregnant women of the same age with COVID-19, pregnant and recently pregnant people with COVID-19 were more likely to be admitted to an intensive care unit (ICU, 1.8% vs. 1.7%), receive invasive ventilation (0.8% vs. 0.6%), and receive extra corporeal membrane oxygenation (ECMO aka life support, 0.1% vs. 0%). Sadly, 339 mothers with confirmed COVID-19 died (from any cause). However, there was no significant difference in the odds of maternal death between those who were pregnant and not-pregnant with COVID-19.
  • Compared to pregnant people without COVID-19, the odds of maternal death (0.7% vs. 0.2%), maternal ICU admission (4.2% vs. 0.1%), stillbirth (0.9% vs. 0.5%) newborn ICU admission (25.6% vs. 11.3%), and preterm birth <37 weeks (12.4% vs. 7.8%) were significantly higher for pregnant people with COVID-19. There was no significant difference in newborn death, abnormal Apgar score at 5 min, or fetal distress. Pregnant people with and without COVID-19 had similar Cesarean rates (36%) based on 21 studies from many different countries.
  • The latest review shows evidence of significant racial disparities in the risk of severe COVID-19. Non-white ethnicity was linked to increased odds of diagnosis of COVID-19 in pregnancy, severe COVID-19, maternal death with COVID-19, and invasive ventilation with the disease. The multifaceted contributors to this disparity all stem from systemic racism and need to be thoroughly investigated.
  • Risk factors that continue to be significantly linked to severe COVID-19 in pregnancy include maternal age 35 and older, body mass index (BMI) 30 and above, having any pre-existing maternal health problem (including chronic high blood pressure and diabetes), and pre-eclampsia. Having any of these risk factors put pregnant people at increased relative risk of serious complications, ICU admission, invasive ventilation, and death, although absolute rates remain low.
  • You can read the WHO’s news coverage of this research study here.

 A systematic review of guidelines on COVID-19 and pregnancy

 Guidance for pregnant people and new parents in the context of the COVID-19 pandemic remains varied. The authors of a recent systematic review summarized all available recommendations for three areas: infant feeding, post-partum social distancing, and decontamination (DiLorenzo et al. 2021).

  • The analysis included 74 articles (unfortunately, this review was limited to publications in English). Some of the included articles were systematic reviews or narrative reviews with suggested guidelines, and others were case-reports with recommendations. Guidelines came from international organizations such as the WHO and FIGO, as well as specific countries and professional clinician groups.
  • Decontamination recommendations were mostly consistent. They focused on masks, hand hygiene, and proper surface cleaning.
  • Most guidelines emphasized shared decision-making around infant feeding and post-partum social distancing.
  • The majority (including the WHO, FIGO, and RCOG) recommended direct breastfeeding/chestfeeding with enhanced precautions. It is now better understood that COVID-19 is primarily transmitted through aerosols, and viral transmission to the newborn via human milk is very unlikely.
  • Post-partum social distancing recommendations varied, but they noticed that articles published more recently tended to recommend keeping the birthing person and newborn in the same room when possible. The more recent recommendations (including those of the WHO) advocate for skin-to-skin care because of its many known benefits. During rooming-in, it was generally recommended that a two-meter distance and a physical barrier remain between the infected parent and the newborn when the newborn was not being held. Other recommendations to reduce exposure in the post-partum period were timely discharge from the hospital (ideally 24 hours after vaginal birth and 48-96 hours after a Cesarean), social distancing from those outside immediate family, and telehealth if feasible.
  • In their conclusion, the review authors emphasized the importance of shared decision-making. However, the stated, “while the decision making ultimately lies with the parents and providers, we strongly encourage direct breastfeeding and co-habitation of the mother and newborn in the immediate post-partum period.”

 Links to additional recent research we found interesting:

 Corticosteroids Use in Pregnant Women with COVID-19: Recommendations from Available Evidence

 Q and A Section

 Question: I plan to get the COVID-19 vaccine even though I am currently lactating. Will I need to discard my milk for a while after getting the vaccine? 

Answer: No, there is no need to “pump and dump” after getting the COVID-19 vaccine.  

 The Royal College of Obstetricians and Gynecologists (RCOG) states, “Although there is lack of safety data for these specific vaccinations in breastfeeding, there is no plausible mechanism by which any vaccine ingredient could pass to your baby through breast milk. You should therefore not stop breastfeeding in order to be vaccinated against COVID-19.”

 In a statement, the Academy of Breastfeeding Medicine (ABM) also does not recommend cessation of breastfeeding for individuals who are vaccinated against COVID-19. They mentioned that there is a biologically plausible benefit from continuing to breastfeed after vaccination, saying, “Antibodies and T-cells stimulated by the vaccine may passively transfer into milk. Following vaccination against other viruses, IgA antibodies are detectable in milk within 5 to 7 days. Antibodies transferred into milk may therefore protect the infant from infection with SARS-CoV-2.” Indeed, as we mentioned above, there is new evidence from Gray et al. (2021) that vaccine-generated antibodies transferred to newborns via human milk.

 Question: How does access to COVID-19 vaccination vary across the world?

 Answer: More than 540.9 million vaccines have been administered globally, which is around 7 doses for every 100 people (The New York Times).  As expected, the data show that COVID-19 vaccination is not being equitably distributed around the world. Higher-income countries are vaccinating their populations well ahead of lower-income countries. Many countries have yet to vaccinate anyone.

 Israel is the country with the highest percentage of its population fully vaccinated (53%). Meanwhile, the U.S. has fully vaccinated 15% of its population, the U.K. 5%, Brazil <2%, Canada < 2%, and India <1%.

 Tracking vaccination rates by continent, North America has given 26 doses per 100 people, Europe 15 per 100, South America 7.9 per 100, Asia 4.9 per 100, Oceania 1.3 per 100, and Africa 0.7 per 100.

 Question: Could you share more info on the 1-shot (“one and done”) COVID-19 vaccine?

 Answer: Most of the COVID-19 vaccines currently in use require two doses to be fully vaccinated. In February, the U.S. FDA authorized a 1-shot vaccine by Johnson & Johnson (Janssen) for emergency use, making it the third COVID-19 vaccine available in the U.S. It is also available for emergency use in Bahrain, Canada, the E.U., Iceland, Liechtenstein, Norway, Switzerland, and Thailand (The New York Times).

 The Johnson & Johnson vaccine is a viral vector vaccine developed by a U.S. company called the Beth Israel Deaconess Medical Center in Boston, MA. The official vaccine name is Ad26.COV2.S. Unlike the mRNA vaccines, the J & J vaccine uses a method that has been tested for many years. They use inactivated adenovirus (a virus that can cause the common cold, aka the vector) to deliver genetic info to cells. It does not contain live virus and does not integrate into the recipient’s DNA.

 In the U.S., the J & J vaccine was found to have around 72% efficacy. J & J is also studying the effects of two doses of their vaccine, and those results should be available in late 2021. They are planning to launch a Phase 2 study with pregnant participants, as well as studies with newborns, adolescents, and people with compromised immune systems.

 This concludes the research update for March 30, 2021. We hope you found it helpful! Our next research update will come out in May 2021.

 If you would like to submit a follow-up question for our consideration to include in upcoming newsletters, you can submit your question here.

 References

 Allotey J, Stallings E, Bonet M, et al. (2020). Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis BMJ 2020; 370 :m3320. Click here. Free full text!

 DiLorenzo MA, O’Connor S, Ezekwesili C, et al. (2021). COVID-19 guidelines for pregnant women and new mothers: A systematic evidence review. Int J Gynaecol Obstet. 2021 Mar 4. Click here.

 Gilbert P. and Rudnick C. (2021). Newborn antibodies to SARS-CoV-2 detected in cord blood after maternal vaccination. medRxiv [preprint]. Click here. Free full text!

 Gray K., Bordt E., Atyeo C., et al. (2021). COVID-19 vaccine response in pregnant and lactating women: a cohort study. AJOG. 2021 Mar 25 [Articles in press]. Click here. Free full text!

Research Update for February 17, 2021

Hi, everyone. On today’s podcast, we’re going to talk about the updated evidence on COVID-19 and pregnancy. Welcome to the Evidence Based Birth® podcast. My name is Rebecca Dekker and I’m a nurse with my PhD and the founder of Evidence Based Birth®. Join me each week as we work together to get evidence-based information into the hands of families and professionals around the world. As a reminder, this information is not medical advice. See ebbirth.com/disclaimer for more details.

Hi everyone. It has been a while since we published a comprehensive update on the evidence on COVID-19 and its effects on pregnancy. So Anna Bertone, our research editor at Evidence Based Birth®, and I, decided it was time to put together a thorough overview of what we now know about COVID-19 and pregnancy. And we know a lot more than we did a year ago.

So now let’s talk about the updated research on COVID-19 and pregnancy. It’s interesting to think how we all have been so impacted by this pandemic and how much has changed in the last year. I know many of you have been personally impacted or the indirect impacts of economies, schools and other businesses being shut down. A lot has changed in the last year. And one thing that we have now that we didn’t have a lot of a year ago, is information. If you all think back to the beginning of the pandemic, when we were terrified to touch anything, we were wiping down groceries, afraid to go outside, and now we know a lot more about how the virus transmits and how we can help prevent transmission. We even have vaccines on the market, which is something a year ago that seemed so out of reach.

Here at Evidence Based Birth® we’ve been sharing research updates on COVID-19 and pregnancy in our email newsletter since about mid-March of 2020. You can visit evidencebasedbirth.com/covid19 to subscribe to our newsletters and view archives of our old newsletters. I’m giving you this interim update in February, but our next written research update will come out in March. So you’ll get some updated information right now, and then you’ll get some written information by email in March.

Our current global situation was that at the beginning of February. The World Health Organization reported 3.7 million new cases the previous week, which is a 13% decline compared to the week before. That was the third consecutive week showing a decline in cases. The World Health Organization also reported that there were 96,000 new deaths, which was a 1% decline in deaths compared to the prior week. At the time I’m recording this about a few days before this podcast comes out, there have been more than 106 million cases around the globe and 2.3 million deaths from COVID-19. These cases and deaths have been reported from 222 countries and territories.

In all of the World Health Organization regions, except Southeast Asia, reported a decline in new cases. And although I said, new deaths declined globally by 1%, they did rise in the Western Pacific, Eastern Mediterranean and the Americas. I encourage you to go to the Johns Hopkins website and you can see a COVID-19 dashboard that they’ve created, that shows the number of global cases and ranks the number of cases by country, region or sovereignty. The countries reporting the highest number of new COVID-19 cases continue to be the United States, Brazil, the United Kingdom, France and Russia.

The World Health Organization has also put out charts that show the epidemic curve of confirmed COVID-19. Just out of curiosity, we pulled up the report from April, 2020 and looked at it compared to January, 2021. It’s really fascinating to see that April of 2020, when everyone around the world was freaking out and extremely scared to leave their houses, is now just a tiny blip in the overall curve. So the number of cases that were happening back then are just a fraction of what has been going on around the world recently.

In the beginning of the pandemic, we talked a lot about flattening the curve, and flattening the curve means that the trend line of total cases is flat. To get their countries must have a downward trend in the number of daily new cases. The seven day average daily confirmed new cases are going down in the United States, Brazil, United Kingdom, Russia and Spain, but it’s going up in France and Italy. By February eight of 2021, epidemiologists believe that the worst of the latest surge of the pandemic seems to be subsiding. However, experts fear new, more contagious virus variants could reverse gains that we’ve been making over the past month.

Unfortunately, some epidemiologists say that what we are seeing right now might be described as the eye of the hurricane and that although we’re seeing encouraging results right now, we don’t know the effect of these new variants. In particular, we don’t necessarily know how efficacious all of the vaccines will be against the new variants. Now, the fact that some experts say were in, what they describe as the eye of the hurricane, it sounds very dire and depressing, but the truth is we don’t know what the future holds, experts can speculate and make guesses and have expert opinions based on past pandemics. But for right now, we are not certain what next fall and winter will look like.

Some people are wondering if the decline in cases could be due to vaccine rollout. However, epidemiologists believe in general, that it’s too early to be seeing population effects from the vaccine rollout. Vaccines are not expected to have a large impact on viral spread until many more people have received the vaccine. So right now we’re all still focused on prevention, especially, prevention during pregnancy, because that’s one of our focuses here at Evidence Based Birth®, is pregnancy, and birth, and postpartum. Current recommendations from the CDC in the United States, state that pregnant people should follow the same recommendations as non-pregnant people for avoiding exposure to SARS-CoV-2, the virus that causes COVID-19 illness.

Recommendations from the CDC include wearing a mask over your nose and mouth, staying six feet away from people who don’t live in your household, avoiding crowded places, meeting in outdoor spaces when possible, and trying to ventilate indoor spaces, washing your hands often, cover coughs and sneezes, clean and disinfect frequently touched surfaces, and be alert for symptoms of COVID-19.

Fortunately, pregnancy has not been shown to increase the risk of catching an infection with COVID-19. It may increase the risk of severe illness, which I’ll talk about in a little bit. In terms of COVID-19 prevention with vaccines, many vaccines are being developed around the world, but pregnant and lactating individuals have been excluded from every single trial so far. This means that as of early February or mid-February, we still do not have any data yet on the maternal fetal or newborn effects of these vaccines. There have been some concerns from people in social media that vaccines might affect fertility, there’s no evidence on this topic yet, but scientists do not think it’s biologically possible that the vaccines for COVID-19 would affect fertility.

And currently guidelines in the United States in the United Kingdom, do not advise vaccine recipients to delay pregnancy after they’re vaccinated. We’re expected to see pregnant people included in vaccine trials sometime this year in 2021. But here at Evidence Based Birth®, we haven’t seen any data reported on that yet. In a news conference, Dr. Fauci, in the United States said on January 21st, that 20,000 pregnant women had received the COVID-19 vaccine with no red flags, and quote, but here at EBB, we have not seen the data on this or any research studies or press releases from studies published on this topic.

Right now, if a vaccine is offered to you, getting vaccinated is a personal choice, especially during pregnancy. Without any data on the vaccine in pregnancy guidance from professional groups has been vague due to the lack of evidence of vaccine efficacy and safety during pregnancy. Guidance that these organizations are issuing must balance the risk of COVID-19 infection to pregnant and lactating people with the potential or theoretical risks from the vaccine. At the time I’m recording this ACOG, the American Congress of Obstetricians and Gynecologists has stated that the vaccine for COVID-19 should not be withheld from pregnant people if you are in a recommended group to receive the vaccine.

A consult with the clinician is not required, there’s no need to test for the pregnancy before the vaccine and they also state that they support those who decline the vaccine when pregnant. In terms of recommendations for lactating individuals, ACOG says that it should be offered the same as to non lactating individuals when you’re in an eligible group to receive the vaccine that the theoretical safety concerns do not outweigh the potential benefits, and there’s no need to avoid breastfeeding or chestfeeding when you’re having the vaccine. While the CDC says people who are pregnant and part of a group currently recommended to receive the COVID-19 vaccine may choose to be vaccinated. They also state that there’s no data on the safety or the effects of the vaccine and lactation, but the mRNA vaccines are not thought to be a risk to the breastfeeding or chestfeeding infant.

In the United States, as in other countries, the vaccine rollout is not necessarily standardized, in the United States it’s different state to state, depending on where you live. However, the CDC divided people up into phases. In Phase 1a, included healthcare workers and residents at long-term care facilities. Phase 1b, included frontline essential workers and people aged 75 and older and the US Phase 1c is people aged 65 to 74 years, as well as people aged 16 to 64 years with underlying medical conditions, which increase the risk of serious life threatening complications from COVID-19 as well as other essential workers.

So just people who work in transportation and logistics, food service, housing construction and finance, information technology, communications, energy, law, media, public safety, and public health. Right now, pregnancy is not explicitly listed as being part of either of these phases, 1a, 1b or 1c. However, if you are pregnant and you fall into one of these categories, for example, if you’re a healthcare worker or you’re another essential worker, then you may be offered the vaccine in the United States as part of that phase rollout.

If you’re looking for, evidence-based kind of condensed easy to read information about the vaccine in pregnancy, I recommend the handout from the Royal College of Obstetricians and Gynecologists in the United Kingdom. They have a handout that was published on January 12th and in the United Kingdom, the vaccine is only currently being offered to pregnant people with high risk medical conditions and health or social care workers. With the World Health Organization, at first, the WHO recommended against COVID vaccination in pregnancy, except in select circumstances. However, a few days later on January 29, they revised their statement using more permissive language saying that, quote, pregnant women at high risk of exposure to SARS-CoV-2, e.g. health workers, or who have co-morbidities, which add to their risk of severe disease, maybe vaccinated in consultation with their healthcare provider, in quote, there are so many vaccines in development and we covered the type of vaccines, the company that’s making them and more information about how they work in one of our past newsletters, which you can find archived on our COVID-19 resource page.

There are at least 89 vaccines that are being investigated in animal studies. 67 vaccines are in clinical trials with 20 in phase three trials, which are the largest kind of the last trial before you can apply for public use. Six vaccines have been authorized for early or limited use in certain countries and four vaccines have been approved for full use in certain countries. The Pfizer-BioNTech vaccine is approved in Bahrain, Saudi Arabia, and Switzerland, and authorized for emergency use in many countries, including the US, Canada, Australia, Mexico, the Philippines and the United Kingdom. The Moderna vaccine is approved in Switzerland and is authorized for emergency use in many countries, including the US, Canada, the EU and the UK. Here in the United States, where I’m located the two vaccines that are currently authorized and recommended to prevent COVID-19 are the Pfizer-BioNTech vaccine and the Moderna vaccine.

These are both messenger RNA vaccines that do not contain live virus. Three more vaccines, the AstraZeneca vaccine, the Novavax vaccine, and the Janssen Biotech vaccine also known as Johnson & Johnson are in large phase three clinical trials in the United States. The US FDA has scheduled a public meeting of its advisory committee to discuss the request for emergency use authorization for the Janssen Biotech, aka, Johnson & Johnson vaccine on February 26. So we should have more information about the Johnson & Johnson vaccine at the end of February. As far as testing and diagnosis goes, that’s something else that has changed a lot in the last year. I don’t know if you remember, how people who were sick a year ago, had a hard time getting tested anywhere around the world. Now COVID-19 diagnosis is done with Nucleic Acid Amplification Testing, NAAT, most commonly using a reverse transcription Polymerase Chain Reaction assay abbreviated, RT-PCR, which detects SARS-CoV-2 RNA from the upper respiratory tract.

These PCR tests are considered the gold standard for testing for COVID-19. Antigen tests are another type of diagnostic test. They detect a specific protein in SARS-CoV-2. Antigen tests are sometimes used first, they’re often found in rapid tests, but these tests are less sensitive. So negative antigen tests should usually be confirmed with a PCR test, if there is a clinical suspicion of COVID-19. The majority of rapid tests on the market so far have been antigen tests. However, there are now some rapid PCR based tests available in some care settings. False negative tests are possible, so even with the PCR test, which is more sensitive, a negative PCR tests may need to be repeated if there’s a high clinical suspicion of COVID-19. Also false positives have been reported, but they’re thought to be less common than false negatives.

One of the things we started seeing in April of 2020 was universal testing implemented on labor and delivery units when people came in to give birth. Facilities have sometimes considered a universal testing strategy, because they’re worried about the potential for asymptomatic patients presenting to labor and delivery units. Particularly in parts of the world where there’s a high prevalence of COVID-19. In one study carried out in Queens, New York, a total of 126 obstetrics patients were universally screened at their hospital for SARS-CoV-2 between March 29 and April 22 of 2020, of these patients, 37% were positive and of those who tested positive, 72% were asymptomatic at the time of testing. Meaning there was a high prevalence of asymptomatic COVID in New York city at the time they were doing this universal testing strategy.

It’s possible that people who develop a fever during labor or after birth may need to be tested or retested, especially if they also have respiratory symptoms. Throughout the pandemic the CDC has been updating their considerations for inpatient obstetric healthcare settings in the US and these considerations apply to facilities providing obstetric care for pregnant people with confirmed COVID-19 or those who are considered persons under investigation in inpatient settings, including triage units in OB, labor and delivery recovery and inpatient postpartum settings.

So you can visit the CDC website or just Google “CDC Considerations for Inpatient Obstetrics,” and you can find their guidelines there. During the pandemic there have been several registries for people who are pregnant and developed COVID-19 so that we can gather more information and understand more about the course of this infection during pregnancy. Moving forward, these registries will give us better evidence as analysis of the data are published.

The PRIORITY study in the US is the official United States registry led by the University of California at San Francisco. There’s also the International Registry of Coronavirus Exposure in Pregnancy or IRCEP. This is a registry led by an international group of investigators. In the United Kingdom, all cases of COVID-19 and pregnancy should be reported to the UK Obstetric Surveillance System, or UKOSS. They’re trying to register all pregnant people with COVID-19 admitted to the hospital between March, 2020 and March, 2021. There’s also an international registry called COVI-PREG led by a Swiss researcher. So we are beginning to get some research evidence from these pregnancy registries, which is super helpful.

One interesting finding from a large registry is about COVID symptoms during pregnancy. I already mentioned the US PRIORITY study. This is an ongoing prospective nationwide study in the US of pregnant or recently pregnant people. They found that symptoms of COVID-19 are similar between pregnant and non-pregnant patients. However, some symptoms do appear to be less common during pregnancy such as fever, especially if you’re outpatient and not admitted to the hospital. Another interesting finding from the US PRIORITY study was that half of everyone in the study had their symptoms resolved by 37 days, but symptoms of COVID-19 lasted for eight weeks or longer in 25% of pregnant PRIORITY participants. That’s a significant amount of time to be experiencing symptoms of COVID-19.

In this study, 95% of participants were outpatients, meaning they were not admitted to the hospital. The researchers in this registry pointed out for that most people acetaminophen or Tylenol is the preferred pain reliever and fever reducer to use during pregnancy. And they stated that it’s important to control fever during pregnancy, especially during the first trimester. There Was another dataset published by the Centers for Disease Control, it was much larger than the PRIORITY group. And it reflects more severe cases of COVID compared to PRIORITY. Results from this dataset were published by Zimbrano et al, in 2020.

In this report, they found that more hospitalized pregnant people with COVID-19 show increased rates of symptoms compared to non-hospitalized pregnant people with COVID-19. In this dataset, they included more than 23,000 pregnant people in over 386,000 non-pregnant females of reproductive age, all with symptomatic laboratory confirmed SARS-CoV-2 infection. So this dataset is reflecting more severe cases of COVID compared to PRIORITY.

In this report, looking at the people who are pregnant, 50% had a cough, 32% fever, 37% muscle aches, 24% chills, 43% headache, 26% had shortness of breath, 28% had a sore throat, 14% diarrhea, 20% nausea and vomiting, 8% abdominal pain, 13% runny nose, 22% reported new loss of taste or smell, and 14% had fatigue, 2% wheezing and 4% chest pain. A report by Berghella and Hughes in 2021 found that most people infected during pregnancy more than 90% will recover before they give birth and without needing hospitalization for COVID-19. And they stated that it is reassuring that the majority of pregnant people with COVID-19 either have no symptoms or, quote, mild illness in quote that does not require hospitalization.

However, mild illness can still feel very severe with terrible flu like symptoms on top of typical pregnancy symptoms. And mild illness can drag on for many weeks and even months, like what we saw in the US PRIORITY study, where the symptoms lasted for more than eight weeks in 25% PRIORITY participants. People are now calling this long COVID or long haulers. Mild illness may sound not that bad, but according to the national institutes of health, mild illness is considered symptoms without difficulty breathing or abnormal chest imaging. So you can still feel quite sick with a, quote, mild illness.

Moderate illness is defined as evidence of lower respiratory disease by clinical assessment or imaging and a saturation of oxygen of 94% or greater on room air at sea level. Severe illness is defined as respiratory frequency of greater than 30 breaths per minute, a pulse-ox of less than 94% on room air at level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen of less than 300, or long infiltrates of greater than 50%. And critical illness is defined as respiratory failure, septic shock and, or multiple organ dysfunction. Although I said earlier that pregnant people are not at any increased risk for catching SARS-CoV-2, researchers now see that pregnancy has been shown to increase the risk of severe or critical COVID-19. So if you do get COVID-19 pregnancy increases the risk of it being severe or critical. And I just gave you the definitions of severe or critical.

Given this growing evidence, the CDC now includes pregnant people and its, quote, increased risk, and quote, category for COVID-19 illness. According to the latest US surveillance data from the CDC with more than 400,000 symptomatic females of reproductive age, pregnant people with symptomatic COVID-19, appear to be at an increased risk for ICU admission, invasive ventilation, ECMO, a life support machine and death compared to non-pregnant females of the same age with symptomatic COVID-19. Unfortunately the evidence was limited by large amounts of missing data on pregnancy status, race and ethnicity in info on symptoms and underlying medical conditions. Also, these data were collected through passive surveillance, so they may have been subject to reporting bias, possibly favoring the reporting of severe cases.

Overall, even though the risks are higher in pregnancy, the absolute risk or overall risk of severe or critical illness and death for pregnant patients is low, even lower than the absolute risk of these outcomes during the H1N1 influenza pandemic. In the CDC analysis published by Zimbrano et al the absolute risks for invasive ventilation and death for pregnant versus non-pregnant people of the same age and sex. More 2.9 per 1000 versus 1.1 per 1001, and 1.5 per 1000 versus, 1.2 per 1000 respectively. ECMO was used rarely, but at a higher rate in pregnancy, 0.7 versus 0.3 per 1000. The absolute risk of ICU admission was notably increased, 10.5 versus 3.9 per 1000.

However, this may be due in part to differences in care management during pregnancy. Remember these absolute risks apply to people with lab confirmed symptomatic COVID-19. We don’t know if the risk of these outcomes is increased during pregnancy for people with asymptomatic infection or with symptoms that are so tolerable that they do not seek medical care or get tested. Risk factors for severe or critical COVID-19 during pregnancy are similar to the risk factors in the general population. These include age of 35 and older, BMI of 30 or higher, hypertension and diabetes, both pre-existing and also possibly gestational diabetes.

Importantly, Black, Latina, and indigenous pregnant, and non-pregnant individuals are bearing a disproportionate burden of the pandemic. These groups have higher rates of COVID-19 infections, hospitalizations, and severe outcomes including death. Racial and ethnic health inequities in the pandemic are due to systemic racism that puts Brown and Black bodies at increased risk of getting sick and dying, or having their symptoms ignored or undertreated. When we look at treatment for COVID-19, there’s very little data on medications that can treat COVID-19 during pregnancy. Studies have shown that corticosteroid treatment significantly lowers the 28 day mortality rate or death rate among COVID patients.

And we now know that corticosteroids should not be withheld for treatment of severe or critical COVID-19 if you’re pregnant. The evidence for dexamethasone, a corticosteroid comes from the recovery trial, a large multicenter randomized trial for patients hospitalized with COVID-19 in the United Kingdom. This study was published by the recovery collaborative group in 2020. The randomized trial showed that dexamethasone resulted in a lower 28 day death rate among people receiving either mechanical ventilation or oxygen, but not among those receiving no respiratory support. Even though only six pregnant people were included in the trial, guidance, supports, dexamethasone for use with infected pregnant patients who are receiving supplemental oxygen, or are mechanically ventilated because of possible life-saving benefits.

The recovery trial protocol for pregnancy recommended prednisolone, 40 milligrams orally once daily and in women unable to take oral medications, hydrocortisone 80 milligrams intravenously twice daily, instead of dexamethasone treatment. A prospective meta-analysis from the WHO rapid evidence appraisal for COVID-19 therapies or react study pooled data from seven trials that totaled about 1700 patients. 678 received corticosteroids and about 1,025 received usual care or placebo. In association between corticosteroids and reduce mortality was similar for dexamethasone and hydrocortisone. Suggesting the benefit is a general class effect of glucocorticoids or steroids.

The 28 day mortality rate, the primary outcome was significantly lower among patients who received corticosteroids. ACOG in the United States recommends that dexamethasone a corticosteroid be used for pregnant people with COVID-19 who are receiving supplemental oxygen, or are mechanically ventilated. And then dexamethasone should not be withheld for treatment of COVID-19 due to pregnancy status. Dexamethasone is used in a wide range of conditions for its anti-inflammatory and immunosuppressant effects.

Up-to-date guidance for clinicians advises that, quote, in pregnant women who meet criteria for use of glucocorticoids maternal treatment of COVID-19 and also meet criteria for use of antenatal corticosteroids for fetal maturity, we suggest administering the usual doses of dexamethasone, four doses of six milligrams given intravenously 12 hours apart. To induce fetal maturation and continue dexamethasone to complete the course of maternal treatment for COVID-19, six milligrams orally or IV daily for 10 days, or until discharge, whichever is shorter, and quote.

In terms of treatment for COVID 19, we’ve also seen compassionate use of remdesivir and antiviral in a study published by Berwick et al in 2020, among 86 pregnant and postpartum women with severe COVID-19 who received compassionate use remdesivir, recovery rates with high, with a low rate of serious adverse effects. It was used with severely ill pregnant patients without causing harm to the fetus. Something else we now know about COVID-19 that a year ago, we didn’t really understand, is that COVID-19 is linked to an increased risk of blood clotting and an increased risk of venous thromboembolism or VTEs. These are blood clots that are carried by the bloodstream and plug a blood vessel, especially in ICU patients.

Pregnancy is known to be a hypercoagulable state, meaning there’s an increased tendency towards blood clotting, so people who are pregnant or in the postpartum period have an increased risk to begin with of VTE or venous thromboembolism, compared with people who are not pregnant. In an article by Western Edge et al in 2021, they stated that clinicians should have a low threshold for investigating possible thromboembolic events in COVID-19 patients during pregnancy and postpartum.

Right now ACOG recommendations or the pregnant patients who are hospitalized with severe or critical COVID-19 may be treated with prophylactic dose anticoagulation if there are no contraindications to its use. We are not aware of any evidence to support using anticoagulants to prevent blood clots among pregnant people with a past history of COVID-19 earlier in pregnancy, but who do not have any other clinical indications for the treatment. People with active COVID-19 infections during pregnancy, particularly those with severe or critical disease may benefit from anticoagulants, but the treatment is only recommended right now for those who are hospitalized because of COVID-19.

People hospitalized because of COVID-19 infections may be advised to continue taking the preventive medications following hospital discharge, if they’re still sick from their infection, but say you had COVID-19 in early pregnancy and it did not require hospitalization and it’s a couple months later, if your doctor is recommending anticoagulants, it’s probably because you have non COVID related risk factors for blood clots.

One of the big questions we got last year that we had difficulty answering at the time, but now we have more data on, is that, there’s no evidence suggesting an increased risk of congenital anomalies or any problems with the baby’s development if you develop COVID-19 during pregnancy. There’s also no evidence yet suggesting the infection and early pregnancy increases the risk of miscarriage. However, data on first and second trimester infections are limited at this point. We do know though that maternal COVID-19 has been linked to an overall increased risk of preterm birth, especially among pregnant patients who develop pneumonia, although individual countries have reported seeing decreased rates of preterm birth or no change in rates of preterm birth.

A systematic review of 77 studies from more than a dozen countries that included more than 11,000 pregnant and recently pregnant people with suspected or confirmed COVID-19 estimated that about 17% of their births were pre-termed. This is a three times greater risk of preterm birth with COVID-19 compared to those without the disease. However, most of these preterm births were medically caused or what we call iatrogenic. The spontaneous preterm birth rate in this study was only 6%, which is similar to the rate observed before the pandemic. It’s thought that the complications from COVID-19 such as pneumonia increased the risk of cesarean and preterm birth because providers intervene and cause an early delivery and hopes of improving the maternal respiratory condition.

However, in a paper by Berghella and Hughes published in 2020, they stated that there’s no evidence that planned early birth improves maternal outcomes with severe or critical COVID-19. A study published by Woodworth et al in 2020, looked at US surveillance data of pregnant people with laboratory confirmed COVID-19 infection and they found that of those people with laboratory confirmed COVID-19, 12.9% of them had a preterm birth before 37 weeks. This rate is higher than the reported 10.2% rate of preterm birth among the general US population, which was last reported in 2019. The US PRIORITY registry study so far has not detected a difference in report outcomes, including preterm birth, NICU admission and respiratory disease between infants born to birthing parents testing positive versus those testing negative.

However, the data on that topic only comes from 263 infants. Speaking of the timing of birth with COVID-19 guidelines are pretty consistent in stating that the timing of birth with COVID-19 should be individualized. And that infection is not an indication for cesarean, induction of labor or an operative vaginal birth with forceps or vacuum. When possible it’s best to wait to give birth until after testing negative, then there’s a less chance of passing the infection to healthcare workers into the newborn and in the postpartum period.

However, the decision to postpone birth such as postponing a cesarean or an induction because of COVID must be individualized. People with term pregnancies who have mild COVID-19 might wish to give birth sooner rather than later to avoid the risk of giving birth with more severe COVID-19 should the disease worsen. Severely ill patients who are at least 32 to 34 weeks pregnant with COVID-19 pneumonia may benefit from an early birth, but it’s not clear whether giving birth improves the birthing person’s respiratory disease. Also guidelines state that COVID-19 infection does not change the way labors are cared for with regard to medically indicated procedures, including the need for fetal monitoring or epidurals.

And ACOG state that for patients with a diagnostic test for COVID-19 that was confirmed negative, nitrous oxide or laughing gas may continue to be offered as an option for pain relief. We have seen an increased risk of cesarean though with COVID-19. A report from the UK obstetric surveillance system on pregnant people admitted to the hospital with confirmed COVID-19 in the United Kingdom, found that 59% of them gave birth by cesarean. About half of these were from maternal or fetal compromise and half were for other obstetric reasons, such as slow progress in labor or planned repeat cesarean. And another large systematic review they estimated that about 65% of pregnant people with suspected or confirmed COVID-19 gave birth by cesarean, this paper was published by [inaudible 00:36:29] et al in 2020.

However, many of the studies in this review came from China, where the cesarean rate with COVID-19 was very high early in the pandemic in early 2020. Something else that we know a lot more about now is vertical transmission. Vertical transmission is transmission from the pregnant person to the baby before or during the birth. This has been reported in a few cases, but it’s thought to be extremely rare. Researchers still do not understand how or why a vertical transmission might occur. A few placental infections and a few very early newborn infections have been reported in the research. However, most placenta studied so far from women who were positive for COVID-19 had no evidence of infection and the vast majority more than 95% of newborns born to infected parents are either asymptomatic or only have mild infection at birth.

There’s no evidence that the risk of the baby getting COVID-19 is affected by the mode of birth, the method of feeding the baby or rooming in versus separation. So far, it’s been really reassuring to see that severe or critical COVID 19 is very rare with newborns. Next, I’m going to talk about something that is really fascinating to me, and that is antibody transfer during pregnancy. Maternal antibodies that are transferred to the fetus through the placenta are going to be very important for newborn immunity to COVID-19. Until recently studies on transplacental transfer of maternal SARS-CoV-2 antibodies to newborns has been limited to case reports and small case series of pregnant people with symptomatic COVID.

In 2021, Flannery et al published a retrospective study that took place at a single hospital in Philadelphia. They included more than 1700 pregnant people and their newborns. The participants were all tested for COVID at the time of admission for birth and or tested during pregnancy due to symptoms or potential exposure. The researchers analyze the maternal blood and the cord blood of the baby from the time of birth, looking for antibodies to SARS-CoV-2. They were specifically looking at IgG and IgM antibodies. Let me explain a little bit about that.

Immunoglobulin M or IgM antibodies are typically only detected soon after an infection, later in an infection the immune response changes over to produce IgG antibodies. IgG antibodies can pass through the placenta, IgM antibodies are too big to pass the placenta unless the placenta is damaged. Thus, if you had COVID-19 while you were pregnant, IgG antibodies would be the first type of antibodies to reach the fetus. In most cases, if IgM antibodies were found in a newborn, it would mean that they had been infected with coronavirus from the parent in utero, and that the fetus probably produce its own IgM. However, there is some controversy about the possibility of IgM antibodies crossing over with a very damaged placenta. In this study by Flannery et al, they detected IgG, and or, IgM antibodies to COVID and 6% of the birthing people.

Of the people who had antibodies present only about half had ever tested positive for COVID and most had had asymptomatic cases. They found that 87% of newborns born to people with antibodies also had antibodies to COVID as newborns. It didn’t make a significant difference whether the parent was asymptomatic or symptomatic, regardless, most parents who had antibodies to COVID were passing their protective antibodies to the baby in utero, all the antibodies that they detected in the newborns were IgG antibodies. None of the babies in the study were found to have IgM antibodies.

The fact that they did not find IgM antibodies in the newborn is more evidence that babies rarely get infected in utero. Interestingly, the researchers also observed that the longer, the time period between the start of a pregnant person’s COVID infection and the birth, the more antibodies were transferred to the baby. So if you were infected in the first trimester, they would have detected more antibodies at the time of birth in both the baby and in you. It’s possible that this could have implications for when we should time vaccination and pregnancy, but that’s speculative at this time. In this study, by Flannery et al, maternal infections within two to three weeks of birth were much less likely to result in antibody transfer to the newborn.

Studies have also shown that protective antibodies to COVID can pass through human milk. So researchers have detected antibodies in human milk and in cord blood for babies who’ve had infected parents who are not vaccinated. This is good news because this means that babies are getting antibodies in utero, and that’s probably why they’re rarely getting infected after birth even if their parent has an infection while they’re pregnant, or even if they’re birthing parent is experiencing asymptomatic or mild infections. Right now, the CDC does recommend testing for all newborns, born to mothers with suspected or confirmed COVID-19 regardless of whether or not the baby is showing symptoms of infection, the tests should be performed at approximately 24 hours of age. If the initial test results are negative or not available, testing should be repeated at 48 hours of age.

For newborns who do not have symptoms of infection and if it’s expected that they’re going to be discharged at less than 48 hours, a single test can be performed prior to discharge between 24 to 48 hours of age. It’s important to understand that delayed cord clamping or physiological cord clamping is still best practice, even when the birthing parent has COVID-19. Delayed cord clamping is defined as the cord remaining unclamped for up to five minutes or until cord pulsation ceases and the cord turns white. There’s no evidence that delayed cord clamping increases the risk of giving the virus to the baby and there are substantial known risks to early cord clamping in the first 30 to 60 seconds. Also, we now know that there are antibodies to COVID-19 in cord blood when the birthing parent has been infected.

When it comes to breastfeeding or chestfeeding, the virus has been found in some breast milk samples, but these are very rare case reports. It’s not known whether COVID-19 can be transmitted through human milk, or if any potential viral components if transmitted are even infectious. Right now, professional organizations consider COVID-19 infection, even with symptoms to still be a situation where parents who wish to breastfeed can do so with precautions taken to prevent transmission through respiratory droplets.

Now, I do want to talk a little bit about the implications of the pandemic on the birth experience when it comes to the support people you have at the birth. The Royal College of Obstetricians and Gynecologists in the United Kingdom states that birthing people should be supported and encouraged to have a birth partner present with them during their labor and birth if they wish, they state that the birth partners must not have any symptoms, which could suggest COVID-19 in the proceeding 10 days. And that birth partners should wear a face covering and remained by the birthing person.

Although in general, we have seen that birth partners are allowed in many hospitals around the world during the pandemic. Whereas, first in the beginning, they were not allowed in many places. There are still some problematic parts of the world and even parts of the United States where it’s not guaranteed that you’ll be able to have your partner with you. For example, some hospitals in Massachusetts are not permitting birth partners to be with you during the cervical ripening portion of an induction, which can last several days. Some hospitals will not let birth partners with you during the triage process. Other hospitals are not letting birth partners in during a cesarean, it’s also possible if your birth partner gets infected or develop symptoms of COVID-19 in the week or two leading up to the birth that they might not be permitted to be there.

However, in general, after a huge backlash against disallowing or not permitting in the hospital, it seems that many places around the world are permitting hospitals and during labor and birth, with some notable exceptions. Hospital policies on permitting doulas, however, are much more variable, whether or not doulas are permitted in a hospital, varies from hospital to hospital and policies may change with little or no notice. Unfortunately, even after the pandemic began to slow down last summer, and again, in the last few weeks, hospitals have been reluctant to let doulas back in.

Some governors in the United States have issued statements or rules saying that doulas are not visitors, that they are part of the healthcare team, but even in those situations sometimes hospitals still find ways to keep doulas out of the room. I was curious what’s going on among our members, we have several thousand professional members at Evidence Based Birth® from around the world, as well as instructors who are very in touch with what’s going on. These Evidence Based Birth® instructors as part of their role, they keep track of statistics and local hospital policies.

We also have a large following on Facebook. So out of curiosity, the week before this podcast came out, I posted questions in various venues trying to figure out what’s going on with doula policies in hospitals around the world. You can check out the Evidence Based Birth® Facebook page to see one of those conversations where we received hundreds of comments and submissions about what’s going on in people’s communities.

Interesting thing is that even though in the United States, most labor and delivery staff have been offered the vaccine and many have had both doses of either the Moderna or Pfizer vaccine. There’s still a lot of hospitals that are not letting doulas in, even though doulas are theoretically no longer a risk to the hospital staff who were vaccinated. For example, some areas in Missouri, all of the hospitals are still closed to doulas. In Alabama many hospitals are not open to doulas. All hospitals in the country of Ireland are still closed to doulas. Someone in the Philadelphia area said that the suburbs there are hit or miss, that one of the more progressive hospitals has not allowed doulas in, since March 2020, and their cesarean rates are sky high right now. In contrast, New Jersey hospitals near Philadelphia have been amazing and supportive of doulas being back in the hospital. And the DC Metro area, Virginia hospitals are open to doulas while Maryland hospitals are close to a second support person, such as a doula.

And the DC hospitals, one just reopened to doulas and the others are still closed to doulas. In some parts of the country, such as Tennessee and North Carolina, some hospitals are allowing doulas, but you have to be approved on a list that they’re cultivating, proof of being a certified doula is sometimes requested, which makes it difficult for doulas in training or doulas who choose not to certify because they have a disagreement with their certification organization about philosophical issues. And it also makes it more difficult for community-based doulas many of whom are Black and Brown and serve those communities to get access to these hospitals.

I’m sometimes shocked to see of hospitals with famous names, such as the Mayo Clinic, still not letting doulas in, even though their staff are awfully vaccinated if they’ve accepted a vaccine. And the list just goes on and on in terms of which hospitals are allowing doulas, which ones are not, which ones have restrictions on doulas and require duals to do certain things. In general, these policies can be very harmful to families, especially to Black and Brown families, for whom having an extra advocate in the room can be extremely important, given the American maternity crisis. Some people who are hiring a doula are choosing to labor at home as long as possible with their doula.

However, this only works if you have a spontaneous labor, if you’re having an induction and they don’t permit you to do the induction outpatient, then you may be looking at a two or three-day long labor in the hospital without any extra support. I encourage you to check out the post on our Facebook page at Evidence Based Birth® to see if you can find more about the hospitals near you, you can also check out at Birth Monopoly, they have a hospital policy tracker where you can search local hospital policies on doulas and visitors during the pandemic. And that’s available at birthmonopoly.com/COVID-19.

If you’re going to be birthing during this pandemic, it’s important for you to understand your human rights. It is a human right to have a companion with you during labor, that includes during the cervical ripening process, if you’re having an induction, it’s also a human right to be able to keep your baby with you after the birth. After the birth, the hospital should not separate you from your baby without your explicit permission. Unfortunately, these rights are still being violated in some cases, particularly with people who are admitted to the hospital for labor and they have confirmed or suspected COVID-19.

I would recommend finding out if your hospital requires separation from your partner or your new born postpartum. If you happen to test positive for COVID-19 when you come in, in labor, there are major safety concerns with people being left to labor alone, or to recover alone postpartum without a partner present. Fortunately, the CDC is no longer recommending newborn separation like they did in the beginning of the pandemic. As of December 2020, the CDC was saying, quote, early in close contact between the mother and neonate has many well-established benefits. The ideal setting for care of a healthy term newborn while in the hospital is in the mother’s room commonly called rooming-in.

Current evidence suggests the risk of a neonate acquiring SARS-CoV-2 from its mother is low. Further, data suggests that there is no difference in risk of SARS-CoV-2 infection to the neonate, whether a neonate is cared for in a separate room or remains in the mother’s room in quote. So what changes have you seen during the pandemic when it comes to pregnancy or birth related care. We’ve seen more tele-health visits and some changes to prenatal care schedules. We’ve also seen more self collection for group B strep screening, so swabbing yourself at the end of pregnancy for group B strep. We’ve also seen a reduction in ultrasounds that are not for evidence-based indications. Fewer people are being admitted in early labor, and we’re seeing more community births where that is an option for people. Home birth midwives have been very busy during the pandemic.

For the most part, when I talked to people around the world, I’m hearing reports that there might be more inductions happening than before. In some locations, there may be fewer inductions because they’re trying to decrease elective procedures, but in general providers seem to be trying to schedule births more often, either through inductions or planned cesareans. In many of our professional members at Evidence Based Birth® have been alarmed at the increased cesarean rates in hospitals near them. Wider implications of the pandemic include an increased risk of mental health distress among pregnant people and intimate partner violence. Care providers need to be on heightened alert for these issues and look for ways to help clients manage stress, anxiety, and depression. We’ve also seen more privacy and fewer staff present during childbirth, no visitors during the postpartum periods, so that it’s a bit quieter when you’re recovering from having your baby and early discharge is often being encouraged.

Many different organizations are issuing professional guidance about labor and delivery care during the pandemic. You can access professional guidelines at acog.org, smfm.org, rcog.org.uk and uptodate.com. UpToDate is a website that publishes literature reviews and there’s something that you have to pay for. You have to buy a membership or do a trial. But during the pandemic uptodate.com has made their COVID-19 content free and they have a page devoted to COVID-19 in pregnancy. There is some good news, hopefully with more and more labor and delivery staff becoming fully vaccinated, some restrictions in labor and delivery units might eventually ease up, especially, if consumer or community pressure is applied to those hospitals. Exposing them and highlighting when they are not allowing doula support or partner support.

Also, I hear amazing birth stories all the time. People are still having beautiful empowering births during this pandemic, babies are still being born and bringing joy in a ray of sunshine to what has been for many people a dark year. Another shift I’ve seen is that more than ever before, expecting parents or educating themselves and learning about the importance of self advocacy. Here at Evidence Based Birth® we have never been so busy. We’ve had record traffic to our website, downloads to our podcasts and visits to our social media pages.

The Evidence Based Birth® instructors who teach the official Evidence Based Birth® childbirth class are busier than ever as evidenced by the constant orders coming in for workbooks for the childbirth class, which we were able to shift online, in early March of 2020, within a matter of just a couple of days. Also, doulas, midwives and childbirth educators that have been able to shift to providing more virtual support are finding themselves very busy because as parents anxiety levels go up, they are reaching out for more support and more and more people are learning about options like doula care, childbirth education and community birth.

There’s also been an increasing emphasis in the United States on highlighting the work of Black and Brown doulas, midwives, doctors, nurses, researchers, and public health experts. Legislators, who a few years ago, didn’t even realize that there was a maternal mortality crisis in our country are now proposing bills and legislation and working with Black and Brown doulas and midwives to craft these ideas. At the same time, we’ve seen alarming research come out about the impact of the pandemic around the world, on women and femmes, particularly, in how it relates to their ability to work. Their stress level and their anxiety levels. Unfortunately, although we are seeing signs of hope, this is going to still be a long slow process to dig ourselves out of this mess and I hope that you who are listening are finding ways to make your life sustainable, to find emotional support, mental health support, or whatever support you need to get through this, and to know that it’s okay to cut back or say no, and just focus on surviving.

Find joy and the ways that you can find joy, figure out the things that feed your soul and try to do those things as much as possible even if you have to shift or just how you do them. I’m grateful that we’ve been able to spend the past year putting out research, making this research on COVID-19 and pregnancy accessible. And we plan to continue doing this for as long as it’s necessary on behalf of our research team and the rest of the team at Evidence Based Birth®. I just want to let you know that our hearts go out to you and that we’re going to be with you along in this, continuing to put out the research, so that you can share with others and have a place to get evidence-based information.

That concludes this update on COVID-19 and pregnancy.

Research Update for January 21, 2021

It’s been 6 weeks since our last COVID-19 and pregnancy newsletter.

In this edition of the Evidence Based Birth® COVID-19 Newsletter, we provide an overview of the research on COVID-19 and pregnancy to date, focusing on key findings and recommendations.

**Feel free to forward this email to any friends, family, clients, or colleagues who might find it helpful. If you’re a healthcare worker, feel free to print this off to share at the nurse’s station! Anyone can subscribe to receive these updates by visiting evidencebasedbirth.com/covid19 

The archive of this newsletter will also be posted on that page.

Today’s questions (answered in a Q&A section at the bottom of this email) include:

  • Do we know what the overall pre-term birth rate was in the U.S. for 2020, and how that might compare to other years?
  • I have a history of COVID in early pregnancy, and now my doctor is recommending that I take either aspirin or an anticoagulant for the rest of pregnancy. Is there any research on this?

To ask a question for consideration for future newsletters, submit your question here.

Don’t forget that our COVID-19 resource & pregnancy page includes archives of these newsletters (including past Q & A’s), a sample informed consent form to refuse mother-newborn separation, our virtual doula directory, a free birthing crash course, a link to find our comprehensive EBB Childbirth Class online, and other info you might find useful. You can access that page here.

Research Update for January 21, 2021

  • Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes coronavirus disease 2019 (COVID-19).
  • Black, Latinx, and Indigenous pregnant and nonpregnant individuals are bearing the burden of the pandemic. These groups have higher rates of COVID-19 infections, hospitalizations, and severe outcomes, including death. Racial and ethnic health inequity in the pandemic is due to long-standing structural racism that put brown and black bodies at increased risk of getting sick and dying—not because of their biology, but because of discrimination in all sectors of life (aka systemic racism) 

Numbers Update from Johns Hopkins University 

As of January 21, 2021, there are over 96 million confirmed and probable cases of COVID-19 around the world. The highest number of cases is still in the U.S. (over 24 million), followed by India, Brazil, Russia, the United Kingdom, France, Italy, Turkey, Spain, and Germany.

Prevention

  • Pregnant people are advised to follow the same recommendations as nonpregnant people for avoiding exposure to SARS-CoV-2. These recommendations from the CDC include:
    • Wear a mask over your nose and mouth
    • Stay 6 feet away from people who don’t live in your household
    • Avoid crowded places
    • Meet in outdoor spaces when possible and try to ventilate indoor spaces
    • Wash hands often
    • Cover coughs and sneezes
    • Clean and disinfect frequently touched surfaces
    • Be alert for symptoms of COVID-19
  • Prenatal and postpartum care appointments are important to keep; however, depending on your individual circumstances, it might be appropriate to delay some appointments or meet virtually.
    • Elective ultrasounds are not recommended (ACOG, 2020).
    • GBS screening is still recommended between 36 weeks, 0 days and 37 weeks, 6 days of pregnancy. However, some care settings are giving pregnant people instructions on how to self-collect a vaginal-rectal swab to limit in-person exposure during the pandemic (ACOG, 2020).

Vaccines

  • Many vaccines are being developed, but pregnant and lactating individuals have been excluded from every trial so far. This means we do not have any data yet on the maternal, fetal, or newborn effects of these vaccines.
  • The two vaccines that are currently authorized and recommended to prevent COVID-19 in the U.S. are the Pfizer-BioNTech vaccine and Moderna’s vaccine. They are both messenger RNA (mRNA) vaccines that do not contain live virus.
  • In the U.S., the SMFM (12/21), ACOG (12/21), and the CDC (12/28) recommended that COVID-19 vaccines should not be withheld from pregnant/lactating individuals who are otherwise eligible for the vaccine and desire vaccination.
  • In the U.K., on December 3, the Joint Committee on Vaccination and Immunization initially stated “JCVI favours a precautionary approach, and does not currently advise COVID-19 vaccination in pregnancy.” However, the JCVI updated their guidance on December 30 and now advises that “extremely clinically vulnerable” pregnant people discuss the option of vaccination with their care provider. They listed specific underlying conditions that put pregnant people at very high risk of experiencing serious complications from COVID-19:
    • Solid organ transplant recipients
    • Those with severe respiratory conditions including cystic fibrosis and severe asthma
    • Those who have homozygous sickle cell disease
    • Those receiving immunosuppression therapies sufficient to significantly increase risk of infection
    • Those receiving dialysis or with chronic kidney disease (stage 5)
    • Those with significant congenital or acquired heart disease
  • The JCVI also now advises that pregnant health care workers and pregnant workers in residential facilities can discuss the option of vaccination. In addition, they say that breastfeeding/chestfeeding parents should be offered vaccination if they are otherwise eligible.
  • The Royal College of Obstetricians & Gynecologists released a handout on COVID-19 vaccination and pregnancy (1/12/21). You can access this vaccine info sheet here.

Clinical symptoms and testing

  • COVID-19 symptoms are similar between pregnant and nonpregnant patients; however, some symptoms with infection appear to be less common during pregnancy, especially fever.
  • The U.S. PRIORITY study (Pregnancy CoRonavIrus Outcomes RegIsTrY) is an ongoing prospective nationwide study in the United States of pregnant or recently pregnant people. The most common symptoms in 594 symptomatic patients who tested positive for SARS-CoV-2 infection were cough (20%), sore throat (16%), body aches (12%), and fever (12%) (Afshar et al. 2020). Half of everyone had their symptoms resolve by 37 days, but symptoms lasted for ≥8 weeks in 25% of PRIORITY participants. In the PRIORITY study, 95% of participants were outpatients. The researchers are working to increase enrollment of Latina, Black, and Native American patients. These groups are currently underrepresented in the study (60% of study participants are White) which limits generalizability.
  • Data from the CDC that included more hospitalized pregnant people with COVID-19 show increased rates of symptoms (50% had cough, 32% had fever, 37% had muscle aches, 24% has chills, 43% had headache, 26% head shortness of breath, 28% had sore throat, 14% had diarrhea, 20% had N/V, 8% had abdominal pain, 13% had runny nose, 22% had new loss of taste or smell, 14% had fatigue, 2% had wheezing, and 4% had chest pain (Zambrano et al. 2020).
  • To treat fever and pain, acetaminophen (Tylenol) is preferred over NSAIDs (aspirin, ibuprofen/Motrin/Advil) because of possible worsening of symptoms with COVID-19 (Berghella and Hughes, 2020). Low-dose aspirin is still recommended for preeclampsia prevention as medically indicated, but may not be appropriate for pregnant and recently pregnant patients with suspected or confirmed COVID; care should be individualized (ACOG, 2020).
  • Systematic reviews suggest that the majority of pregnant people who test positive during universal screening are without symptoms (most asymptomatic, but some pre-symptomatic) (Berghella and Hughes, 2020).
  • COVID-19 diagnosis is done with nucleic acid amplification testing (NAAT), most commonly with a reverse-transcription polymerase chain reaction (RT-PCR) assay, which detects SARS-CoV-2 RNA from the upper respiratory tract. PCR tests are considered the gold standard for testing.
  • Antigen tests are another type of diagnostic test. They detect a specific protein in SARS-CoV-2. Antigen tests are sometimes used first, but these tests are less sensitive, so negative antigen tests should usually be confirmed with NAAT if there is clinical suspicion of COVID-19. The majority of rapid tests so far have been antigen tests; however, there are now rapid PCR-based tests available in some care settings.
  • False-negative tests are possible, so a negative RT-PCR test may need to be repeated if there is high clinical suspicion of COVID-19.
  • False-positives have also been reported, but they are thought to be less common than false-negatives.

Maternal outcomes

  • There is no evidence that pregnancy increases the risk of getting infected with SARS-CoV-2.
  • Definitions according to the NIH:
    • Mild illness is considered symptoms without difficulty breathing or abnormal chest imaging.
    • Moderate illness is evidence of lower respiratory disease by clinical assessment or imaging and a saturation of oxygen (SaO2) ≥94% on room air at sea level.
    • Severe illness is respiratory frequency >30 breaths per minute, SaO2 <94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300, or lung infiltrates >50%.
    • Critical illness is respiratory failure, septic shock, and/or multiple organ dysfunction.
  • Most (>90%) of people infected during pregnancy recover before they give birth and without needing hospitalization for COVID-19 (Berghella and Hughes, 2020). It is reassuring that the majority of pregnant people with COVID-19 either have no symptoms or mild illness that does not require hospitalization.
  • However, pregnancy has been shown to increase the risk of severe or critical COVID-19. Given the growing evidence, the CDC now includes pregnant people in its “increased risk” category for COVID-19 illness. Unfortunately, the evidence in limited by large amounts of missing data on pregnancy status, race/ethnicity, and info on symptoms and underlying medical conditions (Zambrano et al. 2020).
  • According to the latest U.S. surveillance data from the CDC (with over 400,000 symptomatic females of reproductive age), pregnant people with symptomatic COVID-19 appear to be at increased risk for ICU admission, invasive ventilation, extracorporeal membrane oxygenation (ECMO, a life support machine) and death compared to nonpregnant females of the same age with symptomatic COVID-19 (Zambrano et al. 2020). Still, the absolute risk of severe or critical illness and death for pregnant patients is low—even lower than the absolute risk of these outcomes during the H1N1 influenza pandemic (ACOG, 2020).
  • In the CDC analysis, the absolute risks for invasive ventilation and death for pregnant versus nonpregant people of the same age and sex were 2.9 versus 1.1 per 1,000 and 1.5 versus 1.2 per 1,000, respectively. ECMO was used rarely but at a higher rate with pregnancy (0.7 versus 0.3 per 1,000). The absolute risk of ICU admission was noticeably increased (10.5 versus 3.9 per 1,000); however, this may be due in part to differences in care management during pregnancy.
  • Remember, these absolute risks apply to people with lab-confirmed, symptomatic COVID-19; we don’t know if the risk of these outcomes is increased during pregnancy for people with asymptomatic infection or with symptoms that are so mild they do not seek medical care.
  • Risk factors for severe or critical COVID-19 during pregnancy are similar to the risk factors in the general population (Westnedge et al. 2021). They include age ≥35 years, BMI ≥30, hypertension, and diabetes (preexisting and gestational) (Allotey et al. 2020; ACOG, 2020).
  • Importantly, Black and Hispanic individuals who are pregnant are disproportionately affected by COVID-19—not because of their biology, but because of systemic racism creating inequitable opportunities for health.
  • Timing of birth with COVID-19 should be individualized. Importantly, COVID-19 infection is not an indication for Cesarean, induction, or operative vaginal birth. When possible, it’s best to wait to give birth until after testing negative. Then, there is less chance of passing the infection to health care workers and to the newborn in the postpartum period.
  • However, people with term pregnancies who have mild COVID-19 may wish to give birth sooner rather than later to avoid the risk of giving birth with more severe COVID-19 (should the disease worsen).
  • Severely ill patients at least 32 weeks of pregnancy with COVID-19 pneumonia may benefit from early birth. But it’s not clear whether giving birth improves the birthing person’s respiratory disease (Berghella and Hughes, 2020).
  • Maternal COVID-19 is linked to an increased risk of A report from the UK Obstetric Surveillance System (UKOSS) on pregnant people admitted to the hospital with confirmed COVID-19 in the UK found that 59% of people gave birth by Cesarean (Knight et al. 2020). About half of these were for maternal or fetal compromise and half were for other obstetric reasons (e.g., progress in labor, planned repeat Cesarean).
  • A large systematic review estimated that about 65% of pregnant people with suspected or confirmed COVID-19 gave birth by Cesarean (Allotey et al. 2020). Many of the studies in this review (24/77) came from China, where the Cesarean rate with COVID-19 was very high early in the pandemic.
  • S. surveillance data of pregnant people with laboratory-confirmed SARS-CoV-2 infection reported that among nearly 4,000 birthing people, the overall Cesarean rate was 34%, which is slightly higher than the U.S. Cesarean rate in 2019 (32%) (Berghella and Hughes, 2020).
  • Wider implications of the pandemic for maternal health include increased risk of mental health distress and intimate partner violence. Care providers should be on heightened alert for these issues and look for ways to help clients manage stress, anxiety, and depression.

Newborn outcomes

  • Maternal COVID-19 has been linked to an overall increased risk of preterm birth, although individual countries have reported seeing decreased rates of preterm birth or no change in preterm birth rates.
  • A systematic review of 77 studies from more than a dozen different countries, including over 11,000 pregnant and recently pregnant people with suspected or confirmed COVID-19, estimated that about 17% of births were preterm (Allotey et al. 2020). This was a three times greater risk of preterm birth with COVID-19 compared to those without the disease. However, most of these preterm births were medically caused (iatrogenic). The spontaneous preterm birth rate was only 6%, which is similar to the rate observed before the pandemic. It’s thought that complications from COVID-19 (e.g., pneumonia) increase the risk of Cesarean and preterm birth because providers intervene in hopes of improving the maternal respiratory condition. However, there is no evidence that planned early birth improves maternal outcomes with severe or critical COVID-19 (Berghella and Hughes, 2020).
  • S. surveillance data of pregnant people with laboratory-confirmed SARS-CoV-2 infection reported that among 3,912 live births with known gestational age, 12.9% were preterm (<37 weeks) (Woodworth et al. 2020). This rate is higher than the reported 10.2% among the general U.S. population in 2019. Please see the Q&A section at the bottom of this newsletter for more discussion of pre-term birth rates during the pandemic.
  • The S. PRIORITY study has, so far, not detected a difference in poor outcomes, including preterm birth, NICU admission, and respiratory disease, between infants (n=263) born to birthing parents testing positive (n=179) versus those testing negative (n=84) (Flaherman et al. 2020). A study with more racial and ethnic diversity also did not detect a difference in poor outcomes (using a combined outcome of preterm birth, severe preeclampsia, or Cesarean for abnormal GHR) by maternal COVID-19 status (Adhikari et al. 2020).
  • There is no evidence suggesting an increased risk of congenital anomalies or any problems with the baby’s development.
  • There is also no evidence suggesting that infection in early pregnancy increases the risk of (Data on first and second trimesters are limited.)
  • Vertical transmission (transmission from the pregnant person to the baby before or during birth) has been reported in a few cases but it is thought to be rare. Researchers still do not understand the mechanisms by which vertical transmission occurs (Westnedge et al. 2021). A few placental infections and very early newborn infections have been reported; however, most placentas studied so far had no evidence of infection. Importantly, there is no evidence that the risk of vertical transmission is affected by mode of birth, method of feeding or rooming in. The vast majority (over 95%) of newborns born to infected parents have been asymptomatic or with only mild infection at birth. It is reassuring that severe or critical COVID-19 is rare with newborns (Westnedge et al. 2021).
  • A large U.S. observational study found that the rate of early newborn infection among infants born to a parent who tested positive was 3%; most of the infected babies were born to parents with no symptoms or mild symptoms (Adhikari et al. 2020).
  • There is no evidence that the risk of stillbirth increases with COVID-19 infection; however, the risk does appear to increase among patients hospitalized with a COVID-19 infection.
  • Analysis of hospitalization data from England did not show an increase in stillbirths in England during the pandemic when compared with the same months in the previous year (Stowe et al. 2020).
  • In the U.S., data from the CDC show a higher stillbirth rate among pregnant people hospitalized with COVID-19 compared to the overall population of pregnant people with lab-confirmed infection (3% versus 0.4%) (Panagiotakopoulos et al. 2020; Woodworth et al. 2020). For comparison, the overall rate of stillbirth in the U.S. is 0.6%. The increase in stillbirth among hospitalized COVID-19 patients may be related to maternal illness, medical intervention to treat COVID-19, and/or disruptions in prenatal care during the pandemic.
  • There have been reports of problems with placental function from COVID-19 infection. However, more data is needed before we know how widespread a problem this is, and whether it’s clinically significant.

Treatment

  • Corticosteroid use with preterm birth is likely safe for pregnant people with COVID-19, and corticosteroid use for severe or critical maternal COVID-19 may also be beneficial (Westnedge et al. 2021).
  • ACOG recommends that dexamethasone, a corticosteroid, be used for pregnant people with COVID-19 who are receiving supplemental oxygen or are mechanically ventilated, and that dexamethasone should not be withheld for treatment of COVID-19 due to pregnancy status.
  • Similarly, UpToDate guidance for clinicians advises that “In pregnant women who meet criteria for use of glucocorticoids for maternal treatment of COVID-19 and also meet criteria for use of antenatal corticosteroids for fetal maturity, we suggest administering the usual doses of dexamethasone (four doses of 6 mg given intravenously 12 hours apart) to induce fetal maturation and continue dexamethasone to complete the course of maternal treatment for COVID-19 (6 mg orally or intravenously daily for 10 days or until discharge, whichever is shorter).”
  • The evidence for dexamethasone treatment comes from the RECOVERY trial, a large, multicenter, RCT for patients hospitalized with COVID-19 in the U.K. (RECOVERY Collaborative Group et al. 2020). The trial showed that dexamethasone resulted in lower 28-day mortality among people receiving either mechanical ventilation or oxygen but not among those receiving no respiratory support. Even though only six pregnant people were included in the trial, guidance supports dexamethasone for use with infected pregnant people who are receiving supplemental oxygen or are mechanically ventilated because of possible life-saving benefits.
  • Pregnancy is a hypercoagulable state (meaning there is an increased tendency toward blood clotting), so people who are pregnant or in the postpartum period have increased risk of thromboembolism (a blood clot that is carried by the blood stream and plugs a blood vessel) compared with nonpregnant people (ACOG, 2020). COVID-19 is also linked to increased blood clotting and increased risk of thromboembolism, especially in ICU patients. Therefore, recommendations are that pregnant patients hospitalized with severe or critical COVID-19 should be treated with prophylactic-dose anticoagulation, if there are no contraindications to its use (ACOG, 2020; Berghella and Hughes, 2020). Clinicians should also have a low threshold for investigating possible thromboembolic events in COVID-19 patients during pregnancy and postpartum (Westnedge et al. 2021). Please see the Q&A section at the bottom of this newsletter for more discussion of anticoagulant drugs.
  • Remdesivir, an antiviral medication, is recommended for pregnant patients who would otherwise be candidates for the treatment. It has been used with severely ill pregnant patients without causing harm to the fetus (Berghella and Hughes, 2020).

Giving birth

  • ACOG guidelines suggest, “In both the inpatient and outpatient settings, it is recommended that the number of visitors be reduced to the minimum necessary, for example, those essential for the pregnant individual’s well-being (emotional support persons).” Importantly, they say, “Labor, delivery, and postpartum support may be especially important to improve outcomes for individuals from communities traditionally underserved or mistreated within the health care system. In considering visitation policies, institutions should be mindful of how restrictions might differentially and negatively affect these communities, which in many areas are also disproportionately affected by COVID-19.”
  • Professional guidelines acknowledge that it may not be feasible to wear a mask during labor, especially during second stage labor (ACOG, 2020). Wearing a mask could make pushing difficult and forceful exhalation may also make the mask significantly less effective. For this reason, those caring for birthing people should use appropriate PPE.
  • Delayed cord clamping is still best practice when the birthing parent has COVID-19 (ACOG, 2020). The cord should remain unclamped for up to five minutes or when cord pulsation ceases. There is no evidence that delayed cord clamping increases the risk of giving the virus to the baby, and there are substantial known risks to early cord clamping. The care provider should wear appropriate PPE.

Rooming in and infant feeding

  • There are many established benefits to rooming in, including increased success breastfeeding and parent-infant bonding. Studies have not found a difference in the rate of transmission when newborns are separated from infected parents versus kept together in the same room. Guidelines now state that newborns should “ideally” be kept together with their infected parent, and that “Decisions about temporary separation should be made in accordance with the mother’s wishes.” (ACOG, 2020).
  • Birthing parents with COVID-19 should be encouraged to breastfeed/chestfeed, but should wear PPE (Westnedge et al. 2021). It is not known whether the virus can be transmitted through breastmilk. One case report detected SARS-CoV-2 RNA in breastmilk, but the viral particles may not have been infectious; most breastmilk samples from positive parents have been negative.
  • Healthy, uninfected birthing parents and newborns are advised to consider early hospital discharge after birth (after 1 day with uncomplicated vaginal births and after 2 days with Cesarean births depending on recovery status) (ACOG, 2020). 

Professional guidance and clinical recommendations

  • Several professional organizations have issued guidance on pregnancy issues during the pandemic. You can access professional guidance at acog.org, SMFM.org, and rcog.org.uk.
  • Also, UpToDate.com has made their COVID-19 content free. They have a page devoted to COVID-19 and pregnancy.

Q and A Section

Question: Do we know what the overall pre-term birth rate was in the U.S. for 2020, and how that might compare to other years?  

Answer: No, the most recent year of birth data from the U.S. Centers for Disease Control (CDC) is 2019. The CDC National Center for Health Statistics (NCHS) released their latest data brief (No. 387) in October 2020 with key findings from the 2019 data. The overall rate of preterm birth rose to 10.23% in 2019, an increase over the 2018 rate of 10.02%. 

We don’t know yet if the U.S. preterm birth rate rose in 2020, although early findings suggest that it may have. The CDC has been collecting info on pregnancy and infant outcomes among pregnant people with lab-confirmed infections through SET-NET (the Surveillance for Emerging Threats to Mothers and Babies Network). Among 3,912 live births to infected parents, 12.9% were preterm (<37 weeks) (Woodworth et al. 2020). As you can see, this is higher than the U.S. preterm birth rate among the general population in 2018 and 2019, and if enough pregnant people experienced infection, this could possibly contribute to a higher preterm birth rate in 2020.

 Individual studies have been mixed on whether they found a difference in preterm births during the pandemic. Decreases in preterm births have been reported in several European countries, sometimes alongside increases in stillbirth. But even within countries, the impact of the pandemic on preterm birth likely varies in sub-populations based on social and economic factors.

 Question: I have a history of COVID in early pregnancy, and now my doctor is recommending that I take either aspirin or an anticoagulant for the rest of pregnancy. Is there any research on this or guidelines to support this practice?

 Answer: We have not seen any evidence to support the prophylactic (preventative) use of aspirin among pregnant people with a history of COVID-19 earlier in pregnancy but without other clinical indications for the treatment. However, recommendations mention that aspirin should continue to be offered to pregnant and postpartum parents as medically indicated during the pandemic (ACOG, 2020). Perhaps your doctor is recommending aspirin for a non-COVID related medical indication? Low-dose aspirin is most commonly recommended during pregnancy to pregnant people at moderate to high risk of preeclampsia.

 As we mentioned earlier in this newsletter, aspirin may not be appropriate for pregnant people with suspected or confirmed COVID-19 because of evidence that NSAIDs (including aspirin) potentially worsen COVID symptoms.

 We are also not aware of any evidence (yet) to support thromboprophylaxis with anticoagulants among pregnant people with a history of COVID-19 earlier in pregnancy but without other clinical indications for the treatment. People with active COVID-19 infections during pregnancy (particularly with severe or critical disease) may benefit from anticoagulation treatment, but the treatment is only recommended for those who are hospitalized because of their COVID-19 disease (Berghella and Hughes, 2020). People hospitalized because of their COVID-19 infections may be advised to continue thromboprophylaxis for 10 days following hospital discharge or longer if they remain ill from their infection. But if you had COVID-19 in early pregnancy and it did not require hospitalization, then your doctor may be recommending anticoagulants because you have non-COVID related risk factors for blood clots (also known as venous thromboembolisms, or VTEs).

 Whenever care providers recommend intervention, you should always feel empowered to ask them if their advice is based on a research study, a clinical guideline, or their professional medical opinion. Also, keep in mind that as the pandemic progresses, new research may come out that provides us with new insights on this topic.

 This concludes the research update for January 21, 2021. We hope you found it helpful! Our next research update will come out in March 2021.

 If you would like to submit a follow-up question for our consideration to include in upcoming newsletters, you can submit your question here.

 References

 Adhikari, E. H., Moreno, W., Zofkie, A. C., et al. Pregnancy Outcomes Among Women With and Without Severe Acute Respiratory Syndrome Coronavirus 2 Infection. JAMA Netw Open. 2020;3(11):e2029256. Click here.

 Afshar, Y., Gaw, S. L., Flaherman, V. J., et al. (2020). Clinical Presentation of Coronavirus Disease 2019 (COVID-19) in Pregnant and Recently Pregnant People. Obstet Gynecol. 2020 Dec;136(6):1117-1125. Click here.

 Allotey, J., Stallings, E., Bonet, M., et al… for PregCOV-19 Living Systematic Review Consortium (2020). Clinical manifestations, risk factors, and maternal and perinatal outcomes of coronavirus disease 2019 in pregnancy: living systematic review and meta-analysis. BMJ (Clinical research ed.), 370, m3320. Click here.

 American College of Obstetricians and Gynecologists (2020). COVID-19 FAQs for obstetricians-gynecologists, obstetrics. Washington, DC: ACOG. Available at: https://www.acog.org/clinical-information/physician-faqs/covid-19-faqs-for-ob-gyns-obstetrics. Retrieved January 7, 2020.

 Berghella, V. and Hughes, B. (2020). UpToDate: Coronavirus disease 2019 (COVID-19): Pregnancy Issues and Antenatal care. Click here.

 Flaherman, V. J., Afshar, Y., Boscardin, W. J., et al. (2020). Infant Outcomes Following Maternal Infection With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2): First Report From the Pregnancy Coronavirus Outcomes Registry (PRIORITY) Study, Clinical Infectious Diseases, ciaa1411. Click here.

 Knight, M., Bunch, K., Vousden, N., et al. Characteristics and outcomes of pregnant women admitted to hospital with confirmed SARS-CoV-2 infection in UK: national population based cohort study. BMJ 2020; 369:m2107. Click here.

 Panagiotakopoulos, L., Myers, T. R., Gee, J., et al. (2020). SARS-CoV-2 Infection Among Hospitalized Pregnant Women: Reasons for Admission and Pregnancy Characteristics — Eight U.S. Health Care Centers, March 1–May 30, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1355–1359. Click here.

 RECOVERY Collaborative Group, Horby, P., Lim, W. S., et al. (2020). Dexamethasone in Hospitalized Patients with Covid-19 – Preliminary Report. N Engl J Med. 2020 Jul 17:NEJMoa2021436. Click here.

 Stowe, J., Smith, H., Thurland, K., et al. (2020). Stillbirths During the COVID-19 Pandemic in England, April-June 2020. JAMA 2020. Click here.

 Wastnedge, E. A. N., Reynolds, R. M., van Boeckel, S. R., et al. (2021). Pregnancy and COVID-19. Physiol Rev. 2021 Jan 1;101(1):303-318. Click here.

 Woodworth, K. R., CDC COVID-19 Response Pregnancy and Infant Linked Outcomes Team, COVID-19 Pregnancy and Infant Linked Outcomes Team (PILOT), et al. (2020). Birth and Infant Outcomes Following Laboratory-Confirmed SARS-CoV-2 Infection in Pregnancy – SET-NET, 16 Jurisdictions, March 29-October 14, 2020. MMWR Morb Mortal Wkly Rep. 2020 Nov 6;69(44):1635-1640. Click here.

 Zambrano, L. D., Ellington, S., Strid, P., CDC COVID-19 Response Pregnancy and Infant Linked Outcomes Team, et al. (2020). Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status – United States, January 22-October 3, 2020. MMWR Morb Mortal Wkly Rep. 2020 Nov 6;69(44):1641-1647. Click here.

Research Update for December 8, 2020 (Special Edition on Vaccines)

COVID-19 Newsletter *Special Edition*

It’s been two months since our last COVID-19 and pregnancy newsletter, and since then we’ve been tracking and collecting the information on the COVID-19 vaccine trials.

In this special edition of the Evidence Based Birth® COVID-19 Newsletter, we focus on the flurry of new information coming out about the COVID-19 vaccine trials. We share key details about these studies, how they were carried out, their early results, and what various experts are saying these findings could mean for the public—especially pregnant health care workers. Finally, we share links to other interesting research that has come out over the last couple of months.

We know that the COVID-19 vaccine will be controversial. Here at EBB, we are not taking a stance on particular vaccines—we’re simply describing the clinical trials on this topic. We hope this information will be helpful, especially because it is only a matter of weeks before health care workers (many of whom subscribe to this newsletter) begin to receive the vaccine.

**Feel free to forward this email to any friends, family, clients, or colleagues who might find it helpful. If you’re a healthcare worker, feel free to print this off to share at the nurse’s station! Anyone can subscribe to receive these updates by visiting evidencebasedbirth.com/covid19

The archive of this newsletter will also be posted on that page.

Today’s questions (answered in a Q&A section at the bottom of this email) include:

  • Could you explain the different types of vaccines in development?
  • How did vaccines get approved so quickly?
  • What does vaccine efficacy mean?
  • What are some things pregnant people should consider if they are offered a coronavirus vaccine?

To ask a question for consideration for future newsletters, submit your question here.

Don’t forget that our COVID-19 resource & pregnancy page includes archives of these newsletters (including past Q & A’s), a sample informed consent form to refuse mother-newborn separation, our virtual doula directory, a free birthing crash course, a link to find our comprehensive EBB Childbirth Class online, and other info you might find useful. You can access that page here.

Research Update for December 8

Numbers Update from Johns Hopkins University

As of 10 AM EDT on December 8, 2020, there are over 66 million confirmed and probable cases of COVID-19 around the world. The highest number of cases is still in the U.S. (15 million), followed by India, Brazil, Russia, France, the United Kingdom, Italy, Spain, and Argentina. These figures are roughly double the numbers we shared in our last research update in early October!

There Are Many Vaccine Candidates in Different Phases of Testing/Approval

  • Numerous vaccines are being evaluated in clinical trials, but pregnant and lactating individuals have been excluded from every trial.
  • Note from EBB: Health care and public health professionals around the world have criticized vaccine companies for excluding people who are pregnant or lactating from these trials. They note that pregnant health care workers may be among the first to be offered the vaccine, and it’s not ethical to exclude them from carefully monitored clinical trials when they may be expected to receive the vaccine when it is publicly available. Unfortunately, it’s extremely common for researchers to exclude pregnant and lactating individuals from clinical research trials of all types. To read more about the history and ethical debate on this subject, see the ACOG Committee Opinion on “Ethical Considerations for Including Women as Research Participants” here.
  • The first vaccine safety trials on humans started in March. As of Sunday, December 6, according to the NY Times Vaccine Tracker, there are 58 vaccines in clinical trials on humans and at least 86 preclinical vaccines being tested in animals.
  • Zero vaccines have been approved for full use (rather than emergency authorization for early/limited use in small groups).
  • Thirteen vaccine candidates (described below) have reached final stages of testing, which involve large Phase 3 trials. Seven vaccines have been approved for early or limited use.
  • The vaccines in clinical trials use different approaches to produce a protective immune response to SARS-CoV-2. They include nucleic acid vaccines, inactivated (killed) virus vaccines, live attenuated (weakened) vaccines, protein or peptide vaccines, and viral-vectored vaccines (Poland et al. 2020). **We will explain the different types of vaccines in the Q&A section at the bottom of this newsletter.**
  1. The Pfizer/BioNTech vaccine
  • Approved for early/limited use in the U.K. on December 2.
  • This vaccine was authorized in the U.K. after submitting Phase 3 clinical trial data (more than 43,000 participants in the U.S., Germany, Turkey, South Africa, Brazil, and Argentina). It will soon be available to British healthcare workers and staff at residential facilities.
  • There is now considerable pressure on the U.S. FDA to approve the vaccine for emergency use in the U.S.; Pfizer/BioNTech was the first company to apply to the FDA for emergency use authorization (Nov. 20).
  • On Thursday, December 10, an FDA advisory panel of outside experts is scheduled to go over the data in a public meeting. If the FDA authorizes Pfizer’s vaccine for emergency use, it could be available in the U.S. in weeks.
  • The CDC has stated that the first recipients will be health-care workers and residents of long-term-care facilities (Dooling et al. 2020).
  • Developed by a U.S. company in partnership with a German company
  • They are claiming 95% efficacy according to Phase 3 trial data, but findings have not yet been published in a peer-reviewed scientific journal. The results of their Phase 1/2 study were published in August in the journal Nature.
  • This was the first U.S. vaccine approved to include children as young as 12 in trials.
  • The vaccine will need to be stored at minus 70 degrees C (minus 94 degrees F), which complicates transport and increases cost.
  1. The Gamaleya Research Institute’s vaccine, called Sputnik V
  • Approved for early/limited use in Russia
  • Viral vector vaccine
  • Developed by Russia’s Ministry of Health
  • First registered vaccine for COVID-19
  • They are claiming at least 92% efficacy according to Phase 3 trial data (40,000 participants in Russia), but findings have not yet been published in a peer-reviewed scientific journal.
  • There are plans to distribute this vaccine in Russia, Argentina, Brazil, India, Mexico, and Venezuela.
  1. CanSinoBIO
  • Approved for early/limited use in China
  • Viral vector vaccine
  • Developed by the Chinese company CanSino Biologics and the Chinese Institute for Biology at the Academy of Military Medical Sciences.
  • Phase 3 trials (40,000 participants) underway in Saudi Aabia, Pakistan, China, and Russia.
  1. Sinopharm/Wuhan Institute of Biological Products’s vaccine
  • Approved for early/limited use in the United Arab Emirates (U.A.E.)
  • Inactivated vaccine
  • First of two vaccines developed by Sinopharm, a state-owned Chinese company.
  • Phase 3 trials (21,000 participants) still underway in the United Arab Emirates, Bahrain, Argentina, Jordan, Morocco, and Peru.
  1. Sinopharm/The Beijing Institute of Biological Products
  • Approved for early/limited use in the U.A.E.
  • Inactivated vaccine
  • Second of two vaccines developed by Sinopharm.
  • Phase 3 trials include 5,000 participants in the U.A.E.
  1. CoronaVac
  • Approved for early/limited use in China
  • Inactivated vaccine
  • Developed by the private Chinese company Sinovac Biotech.
  • Phase 3 trial (9,000 participants) underway in Brazil, Indonesia, and Turkey.
  • Plans to make this vaccine available worldwide in early 2021.
  1. Moderna
  • Genetic vaccine, mRNA technology
  • Developed by a U.S. company called Moderna in Boston, along with the U.S. National Institutes of Health
  • Moderna was the second company (after Pfizer) to apply to the U.S. FDA for emergency use authorization (on Nov. 30). An FDA advisory panel of outside experts is scheduled to go over the data on December 17 in a public meeting.
  • Phase 3 trial (30,000 participants) underway in the U.S.
  • Moderna is planning a trial to test the vaccine on children ages 12 to 18.
  • They are claiming 94% efficacy according to Phase 3 trial data, but findings have not yet been published in a peer-reviewed scientific journal.
  1. AstraZeneca/University of Oxford
  • Viral vector vaccine
  • Developed by a British/Swedish company and the University of Oxford
  • Combined Phase 2/3 trials underway in the U.K. and India (the vaccine is known as Covishield), and Phase 3 trials (30,000 participants) underway in Brazil, South Africa, and the U.S.
  • They are claiming up to 90% efficacy (depending on the dose) according to Phase 3 trial data, but findings have not yet been published in a peer-reviewed scientific journal.
  • There has been a lot of uncertainty over their Phase 3 trial data because of an error in the dose that was given to some of the participants (addressed further on in this newsletter).
  • There are plans to distribute this vaccine around the world, including in the U.S.
  • This vaccine is relatively cheap and only needs refrigeration for storage.
  1. The Janssen Pharmaceutical Companies of Johnson & Johnson
  • Viral vector vaccine
  • Developed by a U.S. company called the Beth Israel Deaconess Medical Center, in Boston.
  • Phase 3 trial (60,000 participants) underway in the U.S., Argentina, Brazil, Chile, Columbia, Mexico, Peru, Philippines, South Africa, and Ukraine.
  • This vaccine is administered using a single dose, not a double dose like the other vaccine candidates; however, they are launching another Phase 3 trial to test the effects of giving two doses.
  • There are plans to distribute this vaccine around the world, including in the U.S.
  1. NOVAVAX
  • Protein-based vaccine
  • Developed by a U.S. company in Maryland
  • Phase 3 trial underway in the U.K. (15,000 participants); plans to start a larger Phase 3 trial in the U.S. this month (December).
  • Plans to distribute this vaccine in the U.S. and Australia in early 2021.
  1. Medicago
  • Protein-based vaccine
  • Developed by a Canadian company
  • Phase 2/3 trial began on Nov. 12
  1. Anhui Zhifei Longcom (Chinese company) and the Chinese Academy of Medical Sciences
  • Protein-based vaccine
  • Phase 3 trial underway (29,000 participants)
  1. Covaxin
  • Inactivated vaccine
  • Developed by the Indian company Bharat Biotech, the Indian Council of Medical Research, and the National Institute of Virology.
  • The first vaccine created in India to enter clinical trials.
  • Results from the Phase 3 trial are expected in early 2021, distribution by June.

EpiVacCorona by BEKTOP was approved for early/limited use in Russia before starting a Phase 3 trial. The Vector Institute, a Russian biological research center, developed this protein-based vaccine.

Note about Safety during Clinical Trials

We are going to discuss three vaccines in detail: The Pfizer vaccine, the AstraZeneca vaccine, and the Moderna vaccine. As you read through the following information about the vaccines, it may be helpful for you to understand the rule of Institutional Review Boards and Data Safety and Monitoring Boards, which are used globally to safeguard the rights of research participants.

The Institutional Review Board (IRB) is an administrative body that protects the rights and welfare of human research subjects conducted at an institution with which it is affiliated. An IRB must review and approve all research before it can be conducted at an institution—they can also request modifications of the scientific protocol, monitor all research activities, and disallow a study if they choose. IRBs typically have at least 5 members from different backgrounds, including at least one member who is not affiliated with the institution and one member who is not a scientist. The IRB can also require and approve the investigator’s proposed Data Safety and Monitoring Board.

The Data Safety and Monitoring Board (DSMB), sometimes called a Data Monitoring Committee, should be used in all trials when there is safety risk (called “greater than minimal risk”) to participants in the study. The size of the DMSB typically ranges from 3 to 10 experts. The DSMB members must be free from significant conflicts of interest (such as financial, professional, or regulatory conflicts), and they cannot be directly involved in the conduct of the study. These criteria ensure that the DSMB can give informed and independent advice to the investigators. The DSMB then goes on to play a “watchdog” or monitoring role of the study. They monitor the results of the study at scheduled and unscheduled intervals, and they can recommend the investigators stop the trial early (either because the intervention is so obviously beneficial, or because it causes harm).

Around the world, at different institutions, IRBs and DSMBs are supposed to work together to ensure that clinical trials are carried out safely and ethically.

The Pfizer/BioNTech vaccine

  • We’re going to focus on this mRNA vaccine (BNT162b2) because it received the first emergency use authorization in the world following an international Phase 3 trial. As we mentioned, on December 2, the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. granted the vaccine a temporary authorization for emergency use. Pfizer/BioNTech also submitted the first emergency use authorization request to the U.S. FDA on November 20.
  • In addition to the U.K. and the U.S., they submitted requests to other countries including Australia, Canada, Europe, and Japan.
  • The Phase 3 trial began in July and has enrolled over 43,000 participants. Participants were randomly assigned (like flipping a coin) to receive either the experimental viral vaccine or a normal saline placebo. Then they waited to see who developed symptoms of COVID-19 and tested positive. The participants, care providers, and investigators were masked (blinded) to group assignment.
  • By mid-November, the company had conducted its final efficacy analysis before applying for approval. According to the company’s press releases, their vaccine is 95% effective beginning 28 days after the first dose (7 days after the second dose). This finding is based on 170 confirmed cases of symptomatic COVID-19 (of any severity), with 162 cases in the placebo group versus 8 in the vaccine group. A confirmed case of COVID-19 was defined in the study protocol as someone with one or more CDC-defined symptoms of COVID-19 and a positive PCR test. So, they were looking for a reduction in symptomatic infection, not overall infection (including asymptomatic infection), or severe disease with infection.
  • There were 10 severe cases of COVID-19 in the trial, with 9 in the placebo group and 1 in the vaccine group. Again, this trial was designed to detect a reduction in cases of COVID-19 at any severity, not just severe cases.
  • They reported that the vaccine was equally effective across gender, ethnicity, race, and age (over 94% effective among adults age 65 years and over). Around 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% to 45% of participants are 56 to 85 years of age.
  • The trial is ongoing to continue monitoring data; participants will be monitored for two years following their second dose to assess long-term effectiveness and safety. The Data Monitoring Committee has reported no serious safety concerns observed to date. Solicited safety data (data received as a result of targeted data collection) is available from a random subset of about 8,000 adult recipients of the vaccine. Unsolicited safety data (data received spontaneously without request) is available from around 38,000 recipients of the vaccine who were followed for about two months following the second dose of the vaccine. There is also solicited safety data on around 100 children 12 to 15 years of age who received the vaccine. Older adults tended to report fewer and milder side effects from the vaccine. Overall, among the people who received the vaccine, the Grade 3 (severe) adverse events greater than 2% after the first or second dose were fatigue (3.8%) and headache (2%). “Severe” side effects were defined in the study protocol as those that prevent “daily routine activity.” We could not find additional info about side effects in the company’s press releases (e.g., how the rate of side effects compared between vaccine and placebo groups, and if there were any more serious reactions). More details will be available in forthcoming peer-reviewed papers.
  • This trial, like the other coronavirus vaccine trials, was not big enough or long-term enough to rule out rare but serious adverse events, or any adverse events that appear months or years after vaccination.
  • Note from EBB: This vaccine trial and others have been criticized for not demonstrating a reduction in overall infection, severe infection, or death. The 95% efficacy refers to symptomatic infection of any severity. Perhaps the investigators chose this primary outcome to speed up the timeline for receiving efficacy results. Trials that are designed with a primary outcome of preventing severe COVID-19 could have difficulty getting enough participants to detect an effect in a short time (Poland et al. 2020). Other concerns about these trials involve the potential for unblinding (people figuring out what group they were in) because of the vaccine side effects, and whether testing was given to people with COVID-like symptoms at the same rate in both groups. These are concerns that will hopefully be addressed when the full data set is published in a peer-reviewed journal.
  • Pfizer/BioNTech say they plan to submit the efficacy and safety data for peer-review in a scientific journal once analysis of the data is completed.

Moderna vaccine

  • The study protocol for the Moderna vaccine stated that they planned to enroll 30,000 participants for the Phase 3 trial. Participants would be blinded and randomly assigned to the experimental mRNA vaccine (MRNA-1273) or a normal saline placebo. On October 22, they announced that enrollment was complete.
  • In a Nov. 30 press release, Moderna stated their vaccine had 94.1% efficacy against COVID-19 and 100% efficacy against severe COVID-19 starting two weeks following the second dose of the vaccine. Of the 30,000 participants, there were 196 cases of COVID-19 (185 cases in the placebo group and 11 cases in the vaccine group). Of these cases, 30 were severe, and all occurred in the placebo group.
  • They reported that efficacy was consistent across age, race, ethnicity, and gender
  • The most common solicited adverse reactions included injection site pain, fatigue, muscle aches and pains, joint pain, headache, and redness at the injection site. Solicited adverse reactions increased in frequency and severity in the vaccine group after the second dose.
  • The company plans to submit their data to a peer-reviewed publication.

AstraZeneca/University of Oxford vaccine

  • The study protocol stated they would enroll 40,000 participants for the Phase 3 trial, blinded and randomly assigned to the experimental viral vector vaccine (AZD1222) or a normal saline placebo.
  • In a Nov. 23 press release, AstraZeneca announced that two different dosing regimens demonstrated efficacy, but one regimen was observed to be superior. One dosing regimen with nearly 3,000 participants showed efficacy of 90% when the vaccine was given as a half dose followed by a full dose one month later. It appears that the half dose was given accidentally. They observed 62% efficacy when the vaccine was given to nearly 9,000 participants as two full doses one month apart. With both dosage regimens, efficacy was assessed beginning 14 days after the second dose.
  • Everyone is very confused by these results! Why would the efficacy be better with a half dose instead of a full dose? You can read some theories in this Time article and here in a BBC news article.
  • Overall, there were 131 cases of COVID-19 (of any severity) among the participants (101 in the placebo group and 30 in the vaccine group). They reported that there were zero severe cases of COVID-19 in the vaccine group.
  • The company says, “The full analysis of the interim results is being submitted for publication in a peer-reviewed journal.”

According to this article in Nature, scientists still have many questions about the vaccines:

  • We don’t know if the vaccines actually prevent transmission of COVID-19. There is a possibility that vaccinated individuals could still be susceptible to asymptomatic infection and spread the virus to others. Pfizer is planning to assess disease transmission in future trials, and AstraZeneca is testing participants to detect asymptomatic infections, but we don’t have the data yet.
  • We don’t know how long vaccine-induced immunity lasts. Researchers will need to monitor participants’ immunity to the SARS-CoV-2 virus over the next year and beyond. Similarly, we also don’t know how long natural immunity lasts among people who have had COVID-19.
  • We don’t know how well the vaccines work in specific groups. Trials have included relatively few children and elderly individuals, and they have excluded pregnant and lactating individuals. However, even though the COVID-19 vaccine trials do not accept pregnant volunteers directly, some of the participants may become pregnant during the trial, which will provide some data.
  • We don’t know which of the vaccine candidates is the most effective and has the best safety profile. Also, different vaccines could be better for different groups of people. The vaccines have different advantages and disadvantages. For example, the Pfizer vaccine has to be stored at extremely cold temperatures. The AstraZeneca vaccine is expected to be the least expensive and easiest to store.
  • We don’t know how the virus will evolve, making the vaccines less effective. A big problem with developing a coronavirus vaccine is that the virus mutates, which could impact effectiveness in the near future. The high efficacy rates reported by Pfizer/BioNTech and others are only based on a few months’ data. Researchers will need to monitor the virus for signs of change and the vaccine may have to adapt.
  • We don’t know the long-term safety concerns of the vaccines. The vaccine candidates are only a few months into their two-year clinical trial periods.

Society for Maternal-Fetal Medicine (SMFM) Statement: SARS-CoV-2 Vaccination in Pregnancy

  • A federal advisory committee in the U.S. recommended that healthcare workers be the first to receive vaccines as soon as they are available. But what about pregnant healthcare workers? The CDC has yet to issue guidance, stating that “Further considerations around use of COVID-19 vaccines in pregnant or breastfeeding HCP will be provided once data from phase III clinical trials and conditions of FDA Emergency Use Authorization are reviewed.”
  • On December 1, the SMFM in the U.S. released a statement on vaccination for SARS-CoV-2 in pregnancy. The statement recommended that health care workers be offered the vaccine even if they are pregnant or lactating. They believe “the theoretical risk of fetal harm from mRNA vaccines is very low.” As far as actual data, there is zero evidence on the fetal effects of the vaccine.
  • The SMFM statement also says “some vaccines may be more suitable for pregnant women.” They did not recommend a specific vaccine for use in pregnancy, but mentioned that AstraZeneca’s vaccine uses a viral-vector technology similar to the one used in the Ebola vaccine, which has been given in pregnancy with an “acceptable safety profile.” Vaccines that use conventional technologies for which there are known data for use in pregnancy (which use technology similar to the seasonal flu vaccines) are still in Phase 1 and 2 trials, and won’t be available for a while.
  • SMFM states that pregnancy is a high-risk condition for severe COVID-19, hospitalization, and death (and therefore pregnant people should not be excluded from vaccine trials).
  • Note from EBB: According to the latest U.S. surveillance data (with over 400,000 symptomatic females of reproductive age), pregnant people with symptomatic COVID-19 appear to be at increased risk for ICU admission, invasive ventilation, and death compared to nonpregnant females with symptomatic COVID-19 (Zambrano et al. 2020). The absolute risks for invasive ventilation and death were 2.9 versus 1.1 per 1,000 and 1.5 versus 1.2 per 1,000, respectively. The absolute risk of ICU admission was noticeably increased (10.5 versus 3.9 per 1,000); however, this may be due in part to differences in care management during pregnancy. Remember, these absolute risks apply to people with lab-confirmed, symptomatic COVID-19; we don’t know if the risk of these outcomes is increased during pregnancy for people with asymptomatic infection or with symptoms that are so mild that they do not seek medical care. Most (>90%) of people infected during pregnancy recover before they give birth and without needing hospitalization for COVID-19. Risk factors for severe COVID-19 during pregnancy include age ≥35 years, BMI ≥30, hypertension, and preexisting diabetes (Berghella and Hughes, 2020).
  • SMFM recommends that counseling “balance available data on vaccine safety, risks to pregnant women from SARS-CoV-2 infection, and a woman’s individual risk for infection and severe disease.”

Guidance in the U.K. is more precautionary

  • In the U.K., the Joint Committee on Vaccination and Immunisation (JCVI) states, “There are no data as yet on the safety of COVID-19 vaccines in pregnancy, either from human or animal studies. Given the lack of evidence, JCVI favours a precautionary approach, and does not currently advise COVID-19 vaccination in pregnancy.”
  • According to the Royal College of Obstetricians and Gynecologists (RCOG), “Women who are breastfeeding are also currently advised not to have the vaccine” and “Pregnant women at high risk, including health care workers, should be offered vaccine as soon as possible after completion of pregnancy and breast feeding.”

Links to additional recent research we found interesting:

 

Q & A Section

Question: What are the different types of vaccines in development?

Answer: Johns Hopkins Resource Center explains that some of the vaccine candidates use traditional vaccine technology and others use new methods. Some traditional vaccines, such as those used for the seasonal flu, polio, and hepatitis A, use inactivated (killed) virus. Several inactivated viruses are being developed and four are in Phase 3 trials (three from China and one from India). There are also attenuated (weakened) virus vaccines in development, but none are in Phase 3 trials yet.

Other traditional vaccines, such as those used for pertussis and hepatitis B, use a part of the virus (typically one or more proteins) to trigger an immune response. In the case of COVID-19 vaccines, they would use the spike protein on the surface of the virus—these are sometimes called protein-based vaccines.

Viral vector vaccines are newer technology. With these, a SARS-CoV-2 gene for the spike protein is inserted into another virus (often an adenovirus) to deliver the gene to human cells. Then, the production of surface spike protein causes the immune system to recognize the virus if infected. AstraZeneca and Johnson & Johnson are both developing their COVID-19 vaccines using the viral vector approach.

The newest technology being used to develop coronavirus vaccines are genetic vaccines that use messenger RNA (mRNA) technology. These vaccines deliver one or more of the coronavirus’ genes into human cells to stimulate immunity. Pfizer/BioNTech and Moderna are developing mRNA vaccines. In many countries around the world, including in the U.S. and the U.K., these mRNA vaccines are going to be the first ones available.

Question: How did vaccines get approved so quickly?

Answer: There are several reasons why the coronavirus vaccines were developed in record time. First, doing several steps in parallel can save time. The Federal government invested money in the companies so that they would start producing the vaccine before the lengthy development stage was completed. So, this financial reassurance allowed the companies to begin manufacturing the vaccine before clinical trials were completed. Instead of having separate Phase 1, 2 and 3 trials, the phases were sometimes combined (e.g., a Phase 1/2 trial). Second, scientists had already been studying other coronaviruses including SARS and MERS, so they already had some understanding of these types of viruses. Third, this was an international effort with lots of global cooperation.

Another reason trial results are coming in fast is because the trials are being conducted in places with outbreaks of COVID-19, so it doesn’t take as long to reach the number of cases needed to show efficacy. Also, the definition of a case of COVID-19 was not restricted to severe COVID-19, so fewer participants were needed to test efficacy in the trials.

Question: What does vaccine efficacy mean?

Answer: Testing “efficacy” is when you evaluate an intervention under controlled circumstances, such as in a carefully controlled double-blind control trial. When you’re testing efficacy, there are not as many complicating issues like access to treatment, or the general public’s acceptance of the treatment. Vaccine efficacy measures how well a vaccine works at preventing disease among vaccinated people compared to unvaccinated people under ideal clinical trial conditions.

The calculation of efficacy involves comparing the risk of infection in the vaccinated group versus the placebo group. Efficacy of 95% means that the infection rate with the vaccine was 95% lower than without the vaccine. The 95% figure comes from dividing the difference in risk between the unvaccinated and vaccinated individuals (sometimes called the risk difference) by the risk in the unvaccinated group.

Vaccine effectiveness is a different concept that applies to how well a vaccine works in the general public or “real world.” We don’t know at this point how effective any of these vaccines will be. You can study effectiveness in research trials, but there have not been any effectiveness studies carried out yet. Researchers need to first test efficacy before moving on to testing effectiveness.

Question: What are some things pregnant people should consider it they are offered a coronavirus vaccine?

Answer: The fact that researchers did not include pregnant or lactating people in the studies has increased the difficulty of decision-making for these populations when they are offered the vaccine. Yet there are signs that pregnant people will be offered the vaccine, especially health care workers, even though they’ve been excluded from research studies thus far, and even though this would likely be “off label” use of the vaccine.

Here are a few things to consider if you face this situation:

  • Consider whether you have health or medical problems that put you at increased risk for severe COVID-19 disease during pregnancy. As we mentioned, most (>90%) pregnant people with COVID-19 recover during pregnancy without needing hospitalization, but some do experience severe disease.
  • Consider whether you have a living situation or occupation that puts you at increased risk of infection. For example, health care workers or nursing home employees are more likely to benefit from vaccine-induced immunity.
  • Consider that we do not have research yet on whether the vaccines reduce transmissibility of the virus (i.e., whether or not it can reduce your chances of passing on the virus to a vulnerable family member). The high efficacy in the trials shows that the vaccine can prevent symptoms of COVID-19, but some experts have expressed concern that vaccines could lead some people to become asymptomatic spreaders, especially if they do not take precautions (such as mask wearing) after receiving a vaccine. Research on this topic is still forthcoming, and it’s too early to conclude that getting the vaccine prevents symptoms AND protects close contacts from catching COVID-19.
  • Consider whether you are heathy and able to socially distance with mask wearing as appropriate. Some healthy pregnant people may prefer this approach over taking a vaccine that does not yet have safety data for pregnancy.
  • Consider whether or not you may have already contracted COVID-19 and may have some natural immunity. We know of many people who are declining tests when they become symptomatic (for a variety of reasons), but with a vaccine coming, it might be useful to know whether or not you have tested positive (although testing is not 100% accurate). On the other hand, we are not sure how long natural immunity lasts, or how much protection it confers. People who had previously been diagnosed with COVID-19 were not permitted to participate in the clinical vaccine trials.
  • Consider the available information from the clinical trials about efficacy and side effects, especially when the peer-reviewed publications eventually come out. Keep in mind that because we have no information on pregnancy or obstetric outcomes OR long-term outcomes, there is no way to measure any impact on fertility and birth defects with the available research.
  • If you’re not pregnant yet, but thinking about becoming pregnant, consider whether you can get a vaccine and complete both doses before getting pregnant. In the U.K., the JCVI advice is that you should not get vaccinated for coronavirus if you may be pregnant or are planning a pregnancy within three months of the first dose.
  • Carry out a “thought” experiment: Consider whether you would be open to receiving the COVID-19 vaccination while pregnant in a clinical trial, while safety data on the vaccine and pregnancy outcomes are not yet available. If you would’ve jumped at the chance to be in that clinical trial, then you would probably be open to receiving the vaccine now, before there are data on the vaccine and pregnancy. On the other hand, if you would have declined to be in the trial, then taking the vaccine might not be the right choice for you. This is not a perfect comparison, because getting a vaccine in a carefully monitored clinical trial is different than getting a vaccine in real world circumstances, but it may give you an idea of what your intuition is telling you.

Some experts believe it will be a reasonable choice to accept, decline, or delay vaccinating for COVID-19 during pregnancy and while lactating. Given the fact that any COVID-19 vaccine use during pregnancy would likely be “off label” (because FDA approval will probably not include use for pregnant individuals), we think it is highly unlikely that coercion will be used to pressure pregnant or lactating people into receiving this vaccine, even for pregnant health care workers.

In an interview, Christopher Zahn, the vice president of practice activities of the American College of Obstetricians and Gynecologists (ACOG), said that pregnant and lactating individuals should consider any available data, individual risk factors, and “unique needs, desires, and values.”

This concludes the research update for December 8, 2020. We hope you found it helpful! Our next research update will come out on February 3, 2020.

If you would like to submit a follow-up question for our consideration to include in upcoming newsletters, you can submit your question here.

Sincerely,

Rebecca Dekker and Anna Bertone

 

References

Berghella, V. and Hughes, B. (2020). UpToDate: Coronavirus disease 2019 (COVID-19): Pregnancy Issues and Antenatal care. Click here. Free full text!

Dooling, K., McClung, N., Chamberland, M., et al. (2020). The Advisory Committee on Immunization Practices’ Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine — United States, 2020. MMWR Morb Mortal Wkly Rep. ePub: 3 December 2020. Click here. Free full text!

Poland, G. A., Ovsyannikova, I. G., Kennedy, R. B. (2020). SARS-CoV-2 immunity: review and applications to phase 3 vaccine candidates. Lancet. 2020 Nov 14;396(10262):1595-1606. Click here. Free full text!

Zambrano, L. D., Ellington, S., Strid, P., et al. (2020). Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status – United States, January 22-October 3, 2020. MMWR Morb Mortal Wkly Rep 2020; 69:1641. Click here. Free full text!

COVID-19 Research Studies Seeking Participants

HOPE COVID study (UCSF California Preterm Birth Initiative)

Click here to learn more

PRIORITY Registry (UCLA Health)

VIDEO: COVID19 in Pregnancy | Yalda Afshar, MD, PhD, Rashmi R. Rao, MD UCLA

AVAILABLE FOR INTERVIEWS: STUDY PARTICIPANT (IN NYC) AND STUDY P.I.  

National Registry Quickly Set Up to Help Doctors Understand Risks COVID-19 Poses to Pregnant Women and Newborns

“It was a call to arms because we have a population of vulnerable folks for whom we have no data.”           Yalda Afshar, MD, PhD, UCLA Biodesign Fellow

LOS ANGELES (April 8, 2020) – A new national registry has been launched by specialists in obstetrics, gynecology and reproductive sciences at UCLA Health and the University of California, San Francisco, to determine COVID-19’s possible effects on pregnant women and newborns.

The registry is enrolling pregnant women and those who have been pregnant or postpartum within the past six weeks who have a confirmed diagnosis of COVID-19 or are being evaluated for that possibility. UCLA Health’s participation is aligned with the goals of UCLA Biodesign, a program that promotes health care innovation and partnerships that develop novel tools and technologies.

Within two weeks of going live, it had received more than 400 patient referrals from around the country.

The novel coronavirus quickly gained a reputation for being particularly dangerous to the elderly and those with preexisting medical conditions, but little is known about its potential impact on the course of pregnancies. The PRIORITY study – Pregnancy CoRonavIrus Outcomes RegIsTrY – is enrolling pregnant women and those who have been pregnant within the previous six weeks who have a confirmed diagnosis of COVID-19 or are being evaluated for that possibility.

“We expect this registry to provide data that will be critical in helping to improve care for pregnant women during this global pandemic,” said Yalda Afshar, MD, PhD, an obstetrician/gynecologist at UCLA Health and a UCLA Biodesign Fellow, who is co-principal investigator of the study.

Although it usually takes many months to develop a national registry, because of the rapidly evolving COVID-19 crisis, the PRIORITY study went from the initial concept to being open for enrollment in two weeks.

“It was a call to arms because we have a population of vulnerable folks for whom we have no data,” said Afshar.

According to Afshar, most of the available COVID-19 data are based on studies of the general population, but these data do not translate meaningfully to pregnant women and their babies.

“Pregnancy in and of itself makes significant changes to the physiology of the body,” Afshar said. “In fact, pregnant women are considered immune-compromised. An infection on top of that results in a potentially very different scenario for both mom and baby.  We wanted to have data relevant to women, for women, so we can take care of them better,” Afshar said.

“With the global reach of this disease, the findings resulting from this work have the potential to impact millions of lives in an entire generation,” said Johnese Spisso, president of UCLA Health, CEO of UCLA Health System, associate vice chancellor of UCLA Health Sciences, and a member of the UCLA Biodesign Program Advisory Board.

History suggests that the virus will make some pregnancies and deliveries more challenging.

“We know that in previous outbreaks of the regular flu, for example, there have been more deaths and poorer outcomes among pregnant women compared with nonpregnant women,” Afshar said. Infection with influenza also is known to increase risk of miscarriage, preterm delivery, fetal death and certain congenital abnormalities.

Afshar, a physician-scientist whose interests include high-risk pregnancy, prenatal ultrasound, genetic testing and congenital heart disease, is overseeing the study with Drs. Stephanie Gaw, Vanessa Jacoby, and Valerie Flaherman, at UCSF where the registry data will be coordinated.

“In addition to gaining a better understanding of the course of the disease, we will investigate disease transmission to determine if it can be passed from a mother to her baby in utero, and during the postpartum period, such as in breast milk,” said Gaw, whose research interest is infectious disease during pregnancy and is leading the bio-specimen core of the study.

“These are questions that we really have no guidance for right now,” Afshar added. “We’re creating protocols on labor and delivery units throughout the country – throughout the world – without really knowing if this is acquired in utero or not.”

Jacoby agreed. “There is an urgent need to address significant gaps in our knowledge about how pregnant women infected with COVID-19 will fare during pregnancy and how the disease may affect outcomes,” she said.

Beyond that, there also is a critical need to understand the affect of health disparities during this pandemic and how some pregnant women, particularly Black and Latina women, may be impacted more severely by COVID-19.

“A central part of the UCLA Biodesign mission is to deliver improved outcomes to patients locally and worldwide. This registry is a perfect example of the way we’re working with leaders in our state and throughout the nation to improve health care throughout the world,” said Jennifer McCaney, co-executive director of the program.

Desert Horse-Grant, senior director of UCLA Health Research and Innovation and co-executive director of UCLA Biodesign, added that UCLA Biodesign is structured to be both transformative and nimble, with the ability to adapt quickly in a rapidly changing world.

“To have a registry up and running in two weeks is a testament to the foresight, professionalism, expertise and dedication of Dr. Afshar and her colleagues, who recognized the significance of this problem and quickly pivoted to take it on,” Horse-Grant said. “Even a healthy pregnancy brings its own unique stressors; imagine adding those to the life-threatening issues the pandemic has created. This important initiative is an opportunity for us to gather valuable health information and learn how best to protect this vulnerable population.”

Women 13 and older, recruited through their health care practitioners – family physicians, midwives and obstetricians – throughout the U.S., will be contacted by phone by a study coordinator. Patients also may enroll in the study without a referral by visiting the website.

After enrolling, patients will complete questionnaires online, by phone or email to provide information on their symptoms, clinical course, pregnancy outcomes and neonatal outcomes. Researchers will collect data regularly from the time of enrollment through the second and third trimesters and postpartum, with the goal of following the mothers and babies up to one year. In addition to the questionnaires, the registry will obtain necessary medical records to collect data on key clinical and pregnancy outcomes.

Patients interested in information about the registry may contact the researchers by emailing Afshar at PRIORITYCOVID19@ucsf.edu. She has also created a “COVID-19 in Pregnancy” video with additional information.

# # # 

STUDY PARTICIPANT AND STUDY CO-PRINCIPAL INVESTIGATOR AVAILABLE FOR INTERVIEWS

  

MEDIA CONTACT:
Sandy Van
808.526.1708 (o) or 808.206.4576 (m)
sandy@prpacific.com

Doula Work During COVID-19 (DePauw University, Butler University)

Many thanks to Dr. Hillary Melchiors (of The Birth Geeks) for alerting us to the relevant work of two anthropologists Angela Castaneda at DePauw University & Julie Johnson Searcy at Butler University. They completed their research on doula services during COVID-19. We wanted to share their findings with our audience!

Click here to read their article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8022595/ 

COVID-19 and Reproductive Effects (CARE) Study (Dartmouth)

The findings of the CARE study https://sites.dartmouth.edu/care2020/findings/ 

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