Should Pregnant Women Get the COVID-19 Vaccine?

An expert discusses why women who are pregnant, planning to get pregnant, or breastfeeding are being offered the vaccine.

Pregnant woman considering COVID-19 vaccine

With COVID-19 vaccinations underway in the U.S., an important question is being asked: Is the COVID-19 vaccine safe for pregnant and lactating women? Pfizer and BioNTech, the developers of the first coronavirus vaccine to be authorized by the U.S. Food and Drug Administration (FDA) for emergency use, did not include women who were pregnant or breastfeeding in its clinical trials. Nevertheless, the American College of Obstetricians and Gynecologists (ACOG) has issued guidance that the COVID-19 vaccine should not be withheld from these individuals.

“Based on how the vaccine works, we don’t think there’s any biologic reason that we should be concerned about its safety in pregnancy,” says Dr. Laura Riley, obstetrician and gynecologist-in-chief at NewYork-Presbyterian/Weill Cornell Medical Center. “What’s really important is that we do have lots of epidemiologic data which suggests that pregnancy plus COVID-19 is not a good mix. Pregnant women have had more admissions to the ICU, more mechanical ventilation, and more deaths, although the absolute number is low. So it’s a risky proposition in pregnancy.”

Dr. Laura Riley

Dr. Laura Riley

Dr. Riley, who is also the chair of the Department of Obstetrics and Gynecology at Weill Cornell Medicine and chair of the Immunization and Emerging Infections Expert Work Group at ACOG, shared with Health Matters what she knows about the Pfizer vaccine and what women who are pregnant, thinking about getting pregnant, or lactating should know.

What is the recommendation for pregnant women?

The recommendation from ACOG, the FDA, as well as the Centers for Disease Control and Prevention (CDC) is all the same for pregnant women. If you’re in a high-risk group that’s going to be offered the vaccine, you too should consider getting the vaccine. You should be offered it just like anybody else. You do not need a doctor’s approval. You can make that decision. But if you want to talk more with someone about the pros and cons, then I would suggest you talk to your OB or your midwife.

What about women who are breastfeeding?

They should get the vaccine and protect themselves from getting COVID. The way this vaccine works, there’s no reason to suspect that it gets into breast milk and can in any way get to the child. We give live vaccines to lactating women all the time. If we were really worried about something, it would be live vaccines, and this is not that, so we have zero concern about this. And we definitely don’t want people to stop breastfeeding to get the vaccine.

Should women who are planning to get pregnant have any reservations?

No. They should just go ahead and get it done. If by chance you become pregnant between the first and second dose, you should complete the series and attain the maximal benefit from the vaccine. The last thing they need is to be in the first trimester and get COVID-19. We know that the vaccine is the best possible intervention to protect ourselves from COVID-19.

Is Pfizer planning trials in pregnant women?

Yes. There are two pieces of information that are very reassuring. One, given our understanding of the way the vaccine works within the body, we do not have concerns that it will be problematic for expectant mothers or their babies. Two, there is animal data — and we have not seen all the animal data — but the preliminary report on the animal data from Pfizer suggest that it is not problematic. That animal data had been presented to the FDA before they could start human pregnancy trials. Those pregnancy trials are starting in January 2021, so that means the FDA is comfortable enough with that data to move forward.

“Everything we know thus far it looks safe, but when we roll it out to millions, we need to remain vigilant and investigate any potential concerns.”

— Dr. Laura Riley

What do you know about the safety of the Moderna vaccine?

The Moderna vaccine is, like the Pfizer vaccine, also an mRNA vaccine, so that’s important because it’s the same conversation about biologic plausibility and its safety. The efficacy looks to be similar to the Pfizer vaccine. To me, putting all that together, I think that’s just going to give us another option for a vaccine to prevent COVID-19.

How will safety continued to be studied?

Everyone’s concerned about safety. There’s already a really robust safety system for vaccines in the U.S. There are many different safety systems that either patients or their providers can feed information into after a vaccine and say, I had this complication, if there was one. And something I’m really excited about is that they’ve added yet another system, which is called V-safe. Once you’re vaccinated, you can just log on and register yourself with the vaccine that you got, and then it asks you daily questions about how you’re feeling. Not only is that yet another safety system, but they have built-in pregnancy questions, which, having done this for years, the other systems don’t really pick up pregnancy well. The other thing to know is that there’s a group at the CDC that is tasked with looking at the data from all these safety systems every single week, and reporting on anything we see that is of concern. And that’s important because we don’t know everything about these vaccines. Everything we know thus far it looks safe, but when we roll it out to millions, we need to remain vigilant and investigate any potential concerns. If a concern is raised, it will be investigated and reported in a timely manner.

Additional Resources

Laura Riley, M.D., is obstetrician and gynecologist-in-chief at NewYork-Presbyterian/Weill Cornell Medical Center and chair of the Department of Obstetrics and Gynecology at Weill Cornell Medicine. Dr. Riley has served as chair of the American College of Obstetricians and Gynecologists’ Immunization and Emerging Infections Expert Work Group and as a member of the Advisory Committee on Immunization Practice at the Centers for Disease Control and Prevention. She is the author of two books, You and Your Baby: Pregnancy and You and Your Baby: Healthy Eating During Pregnancy.