The COVID-19 Vaccine and Pregnancy: What You Need to Know
The first COVID-19 vaccines are rolling out, and with that come many questions regarding the safety and efficacy of the various COVID-19 vaccines in pregnant and lactating women. Lisa Maragakis, M.D., M.P.H., senior director of infection prevention, and Gabor Kelen, M.D., director of Johns Hopkins Office of Critical Event Preparedness and Response, provide information on this topic.
While there are many unanswered questions about the vaccines in this population, Johns Hopkins Medicine agrees with and supports the recommendations of the Advisory Committee on Immunization Practices, the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM).
- Pregnant and lactating women who otherwise meet criteria for vaccination should be offered access to the COVID-19 vaccine.
- This should be a shared decision among a woman, her care partner(s) and medical provider(s), based on individual risk factors and recognizing a current lack of data about the vaccines’ safety and efficacy during pregnancy and long-term maternal and fetal outcomes.
As national recommendations evolve, we will continue to update the following information:
- The Centers for Disease Control and Prevention includes pregnant women as a high-risk group for severe COVID-19 illness, though severe disease is fortunately uncommon.
- Recent data report an increased risk of intensive care unit admission, need for mechanical ventilation and ventilator support, and death in pregnant women with symptomatic COVID-19.
- Co-morbidities (health conditions that may contribute to death) as well as several racial and socio-economic factors increase the risk of severe COVID-19.
- Lactating women are not considered at higher risk of developing severe illness compared with the non-pregnant population.
- There are going to be several vaccine “platforms” available in the next 12–18 months. No study to date has specifically evaluated pregnant and lactating women, though there have been a few pregnant women who were inadvertently enrolled in the studies. While there are no initial concerning safety signals, better data will be available in the coming weeks to months from additional studies.
- The first vaccines to receive emergency use authorization (EUA) are mRNA vaccines. The mRNA vaccines are not live virus vaccines, nor do they use an adjuvant (something that improves the immune response of a vaccine) 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.
- The Food and Drug Administration’s EUA for the Pfizer-BioNTech COVID-19 mRNA vaccine states: “If you are pregnant or breastfeeding, discuss your options with your healthcare provider.”
- ACOG and SMFM recommend that COVID-19 vaccines not be withheld from pregnant women who meet criteria for vaccination. Patients should be counseled as above and a shared decision model used. You can review their recommendations here:
- Side effects of the Pfizer-BioNTech COVID-19 mRNA vaccine are common and include fever (4% after the initial dose and 16% after the second dose), injection site reactions (84%), fatigue (63%), chills (32%), muscle pain (38%), joint pain (24%) and headaches (55%). Discuss these with patients considering vaccination. Acetaminophen can be used in pregnancy to help mitigate some of these side effects.
- Although the vaccine has not been studied in women who are breastfeeding, lactating women should be offered the COVID-19 vaccine similar to non-lactating individuals. This vaccine contains no live virus so is not thought to pose a risk to the baby. There is no need to delay or discontinue breastfeeding in women receiving the COVID-19 vaccine.
- Women actively trying to conceive may get the current COVID-19 vaccines — there is no reason to delay pregnancy after completing the vaccine series.
As always, be sure to talk to your obstetrician about care specific to you.