Article demonstrates data to support the use and accessibility of COVID-19 vaccines in pregnant women
Duke Maternal-Fetal Medicine specialists Geeta Swamy, MD, and Brenna Hughes, MD, MSc, and MFM Fellow Amanda Craig, MD, have published an article in the American Journal of Obstetrics and Gynecology-MFM recommending that COVID-19 vaccines should not be withheld from women solely based on their pregnancy or lactation status when they otherwise meet criteria for vaccination.
With emerging data surrounding COVID-19 vaccines, questions remain regarding the safety and efficacy profiles of these vaccines in pregnant women. The team’s work, titled "COVID-19 Vaccines in Pregnancy," states that considering data available regarding increased maternal morbidity and mortality associated with COVID-19 infection in pregnancy, withholding FDA approved vaccines from this population based on theoretical risks would be unethical.
"Our findings explain the evidence currently available regarding treatment of COVID-19 in pregnancy, and data to support the use and accessibility of COVID-19 vaccines in pregnant women. Upcoming trials should include this high-risk population to investigate vaccine safety and efficacy in pregnancy," said Dr. Swamy, who serves as a co-investigator for the Pfizer COVID-19 vaccine trial, as Chair of the Independent Data Monitoring Committee (IDMC) for GlaxoSmithKline trials involving novel RSV vaccine in pregnant women, and Chair of the IDMC for Pfizer trials involving novel GBS vaccine in pregnant women. She is also the PI for a CDC-funded planned observational study of COVID-19 vaccine in pregnant women (CDC 200-2012-53663).
The authors note that to their knowledge, no clinical trial evaluating vaccines to prevent COVID-19 has included pregnant women. At the time of publication, it was anticipated that by December 2020, the FDA would approve at least one or two mRNA-based COVID-19 vaccine under emergency use authorization (EUA) based on Phase 3 clinical trial efficacy data. Both Pfizer and Moderna have manufactured mRNA-based vaccines with 95% and 94.1% efficacy against COVID-19, respectively. AstraZeneca has manufactured a vaccine using a viral-vector demonstrating efficacy as well and this next generation platform has previously been utilized with the Ebola vaccine and safely administered during pregnancy with an acceptable safety profile. Approval for COVID-19 vaccinations is anticipated later this week.
As noted by the authors, approval of these vaccines will have a tremendous impact on the ongoing pandemic, yet there remains a lack of data for use of COVID-19 vaccine in pregnant women. The article discusses the available data regarding treatment and prevention of COVID-19 in pregnancy and addresses the growing questions regarding how best to approach vaccine access and administration in the pregnant population.
"Despite recommendations from public health advocates for pregnant women, including the CDC, the American College of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics (AAP), pregnant women have not been included in any Phase 2 or Phase 3 COVID-19 vaccine clinical trials to date," notes Dr. Hughes. "The American College of Obstetrics & Gynecology (ACOG), Society for Maternal-Fetal Medicine (SMFM), National Institutes of Health (NIH) and National Academy of Medicine have consistently advocated for the inclusion of pregnant and lactating women in vaccine trials."
Dr. Hughes serves on the SMFM COVID-19 Task Force, and has written guidances for SMFM, ACOG and other national organizations; additionally, she was asked to be a participant on the U.S. Department of Health and Human Services Panel on Guidelines for The Management of COVID-19 by Anthony S. Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases
On December 1, 2020, SMFM released a statement strongly recommending that pregnant women have access to COVID-19 vaccines in all phases of future vaccine campaigns. This recommendation includes healthcare workers, who are being considered prioritized for vaccination, be offered the vaccine if pregnant, and states that vaccination represents the most promising strategy for combatting COVID-19 through primary prevention.
The authors emphasize that pregnant individuals should be given the opportunity, along with their obstetric provider, to weigh the potential risk of severe maternal disease against the unknown risk of fetal exposure, and make an autonomous decision about whether or not to accept vaccine until pregnancy safety data are available.