Any update on safety of the COVID-19 mRNA vaccines in pregnancy?

Families/Kids Vaccines

A: Preliminary data presented to the Advisory Committee on Immunization Practices (ACIP) are reassuring.

Pregnant persons who received the Pfizer-BioNTech or Moderna vaccines did not have increased risk of side effects from the vaccines or bad outcomes (like preeclampsia, miscarriage, preterm birth, neonatal death, or congenital anomalies). More studies and safety monitoring are ongoing, but this is very comforting!

There is good evidence that #pregnancy is a risk factor for severe disease from #COVID-19. Pregnant persons who get COVID-19 are more likely to need ICU admission, need help breathing with machines and breathing tubes, and even death. They are also at increased risk having the baby too early (called preterm birth), which can have potential health consequences for the newborn. Pregnant people were not specifically included in the clinical trials of the COVID-19 vaccines. So, of course, there is a lot of interest in safety of COVID-19 #vaccines in pregnancy.

At the #ACIP meeting on March 1, 2021 (the meeting where they authorized the new Janssen/Johnson and Johnson vaccine), an interesting nugget of info was presented. The US Centers for Disease Control and Prevention (CDC) showed unpublished data on pregnant persons and mRNA vaccines from V-Safe, one of the many vaccine safety monitoring programs in place in the US. At that time, there were over 30,000 pregnancies reported to V-Safe! Pregnant people had similar rates of local reactions (like pain, swelling, redness, or itching at the vaccine injection site) and systemic reactions (like fever, headache, muscle aches, and nausea). There were no significant differences between pregnant persons and not pregnant people. Woo hoo!

V-safe participants who reported pregnancy following COVID-19 vaccination were invited to enroll in a pregnancy registry. If they choose to sign up, they were contacted by the CDC once per trimester, after delivery, and then again when the infant is 3 months old. At the time of the presentation, over 1800 folks enrolled and there were already 275 completed pregnancies! The rates of miscarriage, pregnancy complications (like diabetes or high blood pressure), preterm birth and congenital disorders (disorders present at birth) were the same as the background rates (meaning they happen at the same rate we would normally expect to happen in any given population of people). This is also good news!

Organizations like the American Academy of Family Physicians, Society for Maternal Fetal Medicine, and the American College of Obstetricians and Gynecologists support access to vaccines for pregnant and breastfeeding persons. Individuals who are pregnant or breastfeeding can talk to their primary care clinician about the COVID-19 vaccine to help them make the decision that is right for them. The CDC also has partnered with MotherToBaby, where anyone can ask experts about pregnancy and COVID-19 vaccination. They can be reached at 1-866-626-6847 or can live chat or email here.

So far, the data does not show any significant safety concerns for getting an mRNA vaccine while pregnant. As the Janssen (Johnson and Johnson) vaccine rolls out and becomes more available, we should expect to see more data on that vaccine as well. With this info in hand and knowing the mechanism of action for all available types of vaccines, the vaccines are expected to be safe and effective in pregnancy and breastfeeding. Safety monitoring is still ongoing, and we will update you with new information as it becomes available!

Links below:

MMWR Report Risk of Severe Illness for Pregnant Persons with COVID-19

CDC Info about COVID-19 Vaccines for People who are Pregnant or Breastfeeding

ACIP Meeting Info with the CDC Presentation

American Academy of Family Physicians Considerations for Pregnancy, Breastfeeding, and COVID-19

Society for Maternal Fetal Medicine Statement on Pregnancy and COVID-19 Vaccine

American College of Obstetricians and Gynecologists Statement on Pregnancy and COVID-19 Vaccines

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