Practice Advisory for vaccination of pregnant and lactating patients released after Emergency Use Authorization (EUA) for the Pfizer-BioNtech mRNA vaccine
On December 11, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNtech mRNA vaccine (BNT162b2) for use in individuals age 16 years and older as a 2-dose regimen given 3 weeks apart. This vaccine has shown to be 95% effective at preventing COVID-19 illness after the second dose.
On December 12, 2020, after an explicit, evidence-based review of all available data, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19 illness.
On Sunday, December 13, 2020, the American College of Obstetricians and Gynecologists (ACOG) released a Practice Advisory for vaccination of pregnant and lactating patients against COVID-19. This Practice Advisory was developed by ACOG’s Immunization, Infectious Disease and Public Health Preparedness Expert Work Group which includes the expertise of Brenna Hughes, MD, MSc and Geeta Swamy, MD. Highlights include:
- ACOG recommends that COVID-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination based on ACIP-recommended priority groups.
- COVID-19 vaccines should be offered to lactating individuals similar to non-lactating individuals when they meet criteria for receipt of the vaccine.
- Vaccines currently available under EUA have not been tested in pregnant women. Therefore, there are no safety data specific to use in pregnancy.
- Pregnancy testing should not be a requirement prior to receiving Pfizer-BioNTech vaccine.
- The mRNA vaccines are not live virus vaccines, nor do they use an adjuvant to enhance vaccine efficacy. These vaccines do not enter the nucleus and do not alter human DNA in vaccine recipients.
As a result, mRNA vaccines cannot cause any genetic changes. As more data is obtained, ACOG will continue to update the Practice Advisory, particularly following review of the Moderna vaccine by the FDA on Thursday December 17th, which includes reassuring developmental and reproductive animal studies.
History in the making...Geeta Swamy, MD, Vice Chair for Research and Faculty Development, was one of the first to receive the COVID-19 vaccine at Duke on December 15, 2020. Dr. Swamy 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 as 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).