Last updated March 4, 2021
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. The ACOG Practice Advisory is intended to be an overview of currently available COVID-19 vaccines and guidance for their use in pregnant and lactating patients.
- The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the following vaccines:
- Pfizer-BioNtech mRNA vaccine (BNT162b2): for use in individuals age 16 years and older as a 2-dose regimen given 3 weeks (21 days) apart.
- Moderna mRNA-1273 vaccine: for use in individuals age 18 and older as a 2-dose regimen given 1 month (28 days) apart.
- Janssen Biotech, Inc. (Johnson & Johnson) Ad26.COV2.S vaccine: for use in individuals age 18 and older as a single dose regimen.
- After an explicit, evidence-based review of all available data, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19 (CDC 2020), the use of the Moderna-1273 COVID-19 vaccine in persons aged ≥ 18 years (CDC 2020), and the use of the Janssen (Johnson & Johnson) COVID-19 vaccine in persons aged ≥ 18 years (CDC 2021).
- ACOG recommends that COVID-19 vaccines should not be withheld from pregnant individuals.
- COVID-19 vaccines should be offered to lactating individuals similar to non-lactating individuals.
- 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, limited safety data specific to use in pregnancy is available. See details about the Food and Drug Administration’s (FDA) EUA process below.
- Similar to their non-pregnant peers, vaccination of pregnant individuals with a COVID-19 vaccine may occur in any setting authorized to administer these vaccines. This includes any clinical setting and non-clinical community-based vaccination sites such as schools, community centers, and other mass vaccination locations.
- Pregnancy testing should not be a requirement prior to receiving any EUA-approved COVID-19 vaccine.
- Unfounded claims linking COVID-19 vaccines to infertility have been scientifically disproven. ACOG recommends vaccination for all eligible people who may consider future pregnancy.
- 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.