ACOG | Published December 13, 2020
This Practice Advisory was developed by the American College of Obstetricians and Gynecologists’ Immunization, Infectious Disease, and Public Health Preparedness Expert Work Group in collaboration with Laura E. Riley, MD; Richard Beigi, MD; Denise J. Jamieson, MD, MPH; Brenna L. Hughes, MD, MSc; Geeta Swamy, MD; Linda O’Neal Eckert, MD; Cynthia Gyamfi-Bannerman, MD, MSc; and Mark Turrentine, MD.
Summary of Key Information and Recommendations
COVID-19 vaccine development and regulatory approval are rapidly progressing. Thus, information and recommendations will evolve as more data are collected about these vaccines and their use in specific populations. This Practice Advisory is intended to be an overview of currently available COVID-19 vaccines and guidance for their use in pregnant and lactating patients.
- 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% effectivat 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.
- 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 based on prioritization groups outlined by the ACIP.
Individuals considering a COVID-19 vaccine should have access to available information about the safety and efficacy of the vaccine, including information about data that are not available. A conversation between the patient and their clinical team may assist with decisions regarding the use of vaccines approved under EUA for the prevention of COVID-19 by pregnant patients. Important considerations include:
- the level of activity of the virus in the community
- the potential efficacy of the vaccine
- the risk and potential severity of maternal disease, including the effects of disease on the fetus and newborn
- the safety of the vaccine for the pregnant patient and the fetus.
- While a conversation with a clinician may be helpful, it should not be required prior to vaccination, as this may cause unnecessary barriers to access.
- Vaccines currently available under EUA have not been tested in pregnant women. Therefore, there are no safety data specific to use in pregnancy. See details about the Food and Drug Administration’s (FDA) EUA process below.
- Pregnancy testing should not be a requirement prior to receiving Pfizer-BioNTech vaccine.
- Pregnant patients who decline vaccination should be supported in their decision. Regardless of their decision to receive or not receive the vaccine, these conversations provide an opportunity to remind patients about the importance of other prevention measures such as hand washing, physical distancing, and wearing a mask.
- Expected side effects should be explained as part of counseling patients, including that they are a normal part of the body’s reaction to the vaccine and developing antibodies to protect against COVID-19 illness.
- 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.