COVID-19 Vaccines and Pregnancy: Guide for Clinicians by ACOG

This Practice Advisory was developed by the American College of Obstetricians and Gynecologists’ Immunization, Infectious Disease, and Public Health Preparedness Expert Work Group.

The American College of Obstetricians and Gynecologists (ACOG) recommends that pregnant individuals should have access to COVID-19 vaccines.

While limited, current safety data on the use of COVID-19 vaccines in pregnancy do not indicate any safety concerns. In the interest of patient autonomy, ACOG recommends that pregnant individuals be free to make their own decision regarding COVID-19 vaccination.

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Risk of COVID-19 Infection during Pregnancy

While the known absolute risk is low, pregnancy is associated with increased risk of maternal severe illness, ICU admission, mechanical ventilation and death
There is a known increased risk of complications from COVID-19 in pregnant patients with underlying health conditions (e.g. diabetes, obesity, increasing age, and cardiovascular disease)
There is increased risk for certain racial and ethnic populations

Safety of COVID-19 Vaccines in Pregnancy

Pregnant women were not included in COVID-19 vaccine clinical trials, however observational data from vaccinated pregnant individuals is being collected by CDC and manufacturers and to date no safety signals have been identified

Based on limited self-reported information, no specific safety signals have been observed in pregnant people enrolled in v-safe and the v-safe pregnancy registry; however longitudinal follow-up is needed

Early data from CDC’s v-safe pregnancy registry demonstrate that the side effects and adverse events observed among pregnant individuals in v-safe did not indicate any safety concerns

Data from Developmental and Reproductive Toxicity (DART) animal-model studies for the Pfizer-BioNtech, Moderna, and Janssen (Johnson & Johnson) COVID-19 vaccines have not demonstrated any safety concerns in pregnancy

Based on the mechanism of action of these vaccines and the demonstrated safety and efficacy in Phase II and Phase III clinical trials, it is expected that the safety and efficacy profile of the vaccine for pregnant individuals would be similar to that observed in non-pregnant individuals

Any of the currently authorized COVID-19 vaccines can be administered to pregnant or lactating people;

ACIP does not state a product preference. However, pregnant, lactating, and post-partum people aged <50 years should be aware of the rare risk of thrombosis with thrombocytopenia syndrome (TTS) after receipt of the Janssen COVID-19 vaccine and that other FDA- authorized COVID-19 vaccines (i.e., mRNA vaccines) are available.

Patients receiving the Janssen COVID-19 vaccine should be informed of symptoms of TTS, including severe headache, visual changes, abdominal pain, nausea and vomiting, back pain, shortness of breath, leg pain or swelling, petechiae, easy bruising, or bleeding. Patients who experience these symptoms should be counseled to seek immediate medical evaluation.

None of the COVID-19 vaccines available for use under EUA cause infertility

Safety and Efficacy for the Newborn

There is currently no data available regarding protection of the newborn with maternal immunization

IgG antibodies after maternal vaccination in the third trimester have been shown in observational studies. However, no data is available to demonstrate if this prevents COVID-19 disease in neonates

Covid 19 Vaccines in Lactating Mother

ACOG recommends COVID-19 vaccines be offered to lactating individuals. While lactating individuals were not included in most clinical trials, COVID-19 vaccines should not be withheld from lactating individuals who otherwise meet criteria for vaccination.

Theoretical concerns regarding the safety of vaccinating lactating individuals do not outweigh the potential benefits of receiving the vaccine. There is no need to avoid initiation or discontinue breastfeeding in patients who receive a COVID-19 vaccine.

Vaccine Side Effects

Most study participants for both the Pfizer-BioNtech and Moderna vaccines experienced mild side effects similar to influenza-like illness symptoms following vaccination such as Injection Site Reactions, Fatigue, Chills, Muscle Pain, Joint Pain, Headaches.

Fever was the least common side effect reported.

Pregnant people have not reported different side effects from non-pregnant people after vaccination with mRNA vaccines (Moderna and Pfizer-BioNTech vaccines).

Women younger than 50 years old should especially be aware of the rare risk of blood clots with low platelets after J&J/Janssen vaccination. There are other COVID-19 vaccines available for which this risk has not been seen.

Allergic reactions including anaphylaxis have been reported to be rare following COVID-19 vaccination in non-pregnant individuals.

Summary of Key Information and Recommendations

This Practice Advisory is intended to be an overview of currently available COVID-19 vaccines and guidance for their use in pregnant, recently pregnant, and nonpregnant individuals.

The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the following vaccines:

Pfizer-BioNtech mRNA vaccine (BNT162b2)

Moderna mRNA-1273 vaccine

Janssen Biotech, Inc. (Johnson & Johnson) Ad26.COV2.S vaccine

ACOG recommends that pregnant individuals should have access to COVID-19 vaccines.

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 still unknown.

Important considerations include:

the 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.

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.

Pregnancy testing should not be a requirement prior to receiving any EUA-approved COVID-19 vaccine.

Importantly, claims linking COVID-19 vaccines to infertility are unfounded and have no scientific evidence supporting them. ACOG recommends vaccination for all eligible people who may consider future pregnancy.

Expected side effects should be explained as part of counselling 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.

Women under age 50 including pregnant individuals can receive any FDA-authorized COVID-19 vaccine available to them. However, they should be aware of the rare risk of thrombosis with thrombocytopenia syndrome (TTS) after receipt of the Janssen COVID-19 vaccine and that other FDA-authorized COVID-19 vaccines are available (i.e., mRNA vaccines).

COVID-19 vaccines may be administered simultaneously with other vaccines, including within 14 days of receipt of another vaccine. This includes vaccines routinely administered during pregnancy, such as influenza and Tdap.