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Can Pregnant and Breastfeeding Women Get the COVID-19 Vaccine?

pregnant woman vaccination

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Key Takeaways

  • The EUA for the Pfizer-BioNTech COVID-19 vaccine states that women who are pregnant or breastfeeding should discuss their options with their healthcare provider.
  • Expert groups recommend pregnant women balance available data on vaccine safety, their risks for a COVID-19 infection, and their individual risk for infection and severe disease.

A line is already forming to receive the Pfizer-BioNTech COVID-19 vaccine, which was granted emergency use authorization (EUA) from the Food and Drug Administration (FDA) on December 11. Healthcare employees are up first, a population which includes over 300,000 pregnant or lactating individuals. Is the vaccine safe for them? The FDA suggests the answer is yes, most of the time. According to the EUA, “if you are pregnant or breastfeeding, discuss your options with your healthcare provider."

“I feel strongly that women should be able to have a conversation with their provider about the benefit risk ratio,” Linda O'Neal Eckert, MD, a professor in the Women's Health Division of the Department of Obstetrics and Gynecology at the University of Washington, tells Verywell. Eckert co-authored the American College of Obstetrics and Gynecologists (ACOG) practice advisory "Vaccinating Pregnant and Lactating Patients Against COVID-19." “Many women may choose that the benefit of being protected from COVID-19–a disease that is well known to be so dangerous and even fatal–outweighs the risk.”

On December 12, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in people age 16 and older for the prevention of COVID-19. ACIP is expected to issue vaccine recommendations for specific populations, including pregnant and lactating women, soon.

ACOG recommends that pregnant and breastfeeding individuals who fall into ACIP priority groups should be able to receive the COVID-19 vaccine.

COVID-19 Infection Risk in Pregnancy

According to the Centers for Disease Control and Prevention (CDC), pregnancy is considered a risk factor for severe COVID-19. Data from numerous studies show pregnant women with COVID-19 have an increased risk of ICU admission, need for mechanical ventilation and ventilatory support (ECMO), and death when compared with non-pregnant women with COVID-19.  

ACOG also notes the following subpopulations of pregnant women are at a higher risk for COVID-19 complications:

  • Pregnant women with comorbidities such as obesity and diabetes
  • Black and Hispanic pregnant women
  • Asian and Native Hawaiian/Pacific Islander pregnant women

“Pregnant women and newborns are, by nature, immunocompromised and at higher risk for many infections,” Dena Hubbard, MD, a neonatologist at Children’s Mercy in Kansas City, Missouri and a member of the American Academy of Pediatrics (AAP) Section on Neonatal-Perinatal Medicine, tells Verywell. “I have treated a lot of babies born to COVID-positive mothers–some well babies, some NICU babies.”

What This Means For You

If you are pregnant, know you do have the option to receive the COVID-19 vaccine if you and your doctor agree the benefits outweigh the risks.

Why Pregnant Women Have Been Excluded from COVID-19 Vaccine Clinical Trials

Despite significant advocacy efforts, no pregnant women were included in COVID-19 trials—including those from Pfizer-BioNTech, Moderna, Janssen, AstraZeneca and Novavax. Their exclusion can be attributed to lots of reasons such as:

  • Historical precedent within American’s healthcare system to exclude pregnant women from clinical trials
  • Concerns about delaying FDA approval
  • Concerns about possible harm to the pregnant woman and her fetus

According to a December 1, 2020 statement from Society of Maternal and Fetal Medicine (SMFM), an organization that has long advocated for the inclusion of more clinical research to include pregnant women, “the practice of protection by exclusion is harmful...” Like ACOG, SMFM also strongly recommends that pregnant women have access to COVID-19 vaccines in all phases of future vaccine campaigns, and that she and her healthcare professional engage in “shared decision-making” regarding the vaccine.

During their panel meeting on December 10, the FDA did urge vaccine makers to do studies in pregnant animals before launching trials in pregnant and breastfeeding women. A representative from Pfizer said the company expects data from experiments in rats by the middle of December. The CDC is also funding research at Duke University on pregnant women who choose to receive the COVID-19 vaccine. These results are many months away. 

Hubbard hopes that with time, we will have data and evidence to suggest that the virus is unlikely to transmit from mother to fetus in utero. “Scientists, physicians, public health officials had to act with speed over precision, which resulted in many frequent changes and recommendations based on the best available scientific evidence at the time,” she says. “Trying to keep up with the latest recommendations has been difficult for both the public and those of us on the frontlines.”

Linda O'Neal Eckert, MD

Many women may choose that the benefit of being protected from COVID-19–a disease that is well known to be so dangerous and even fatal–outweighs the risk.

— Linda O'Neal Eckert, MD

Is the Pfizer-BioNTech Vaccine Safe For Pregnant Women?

Safety information on Pfizer’s website states: “Available data on Pfizer-BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.” We know more data will eventually come, but for now all we have is the research on the vaccine’s safety and efficacy published in the peer-reviewed and highly respected New England Journal of Medicine. It shows that of almost 44,000 people, the vaccine was 95% effective at preventing symptomatic cases of COVID-19. Some women in Pfizer-BioNTech’s trials did become pregnant over the course of the trials and experienced no ill effects.

Shannon Rotolo, PharmD, BCPS, a pharmacist at the University of Chicago Medical Center, tells Verywell this scenario isn’t uncommon. “I work with a lot of specialty drugs and therapies that get approved with minimal data in pregnancy,” she says. “I try to do my best assessment and provide that information and perspective to my patients as much as possible so that they can make an informed and supported decision.”

Rotolo said she would be in favor of handling the COVID-19 vaccine the same way and is thankful her institution’s plan is giving pregnant staff the option.

Both Pfizer-BioNTech and Moderna’s vaccines use a new technology called messenger RNA (mRNA) that turns the body’s own cells into vaccine producing factories to fight the coronavirus. The mRNA vaccine:

  • is not a live vaccine, which means there is zero risk of inducing or transmitting COVID-19 through vaccination
  • does not enter the cell nucleus
  • does not have any impact on human DNA
  • has very low theoretical risk of fetal harm

“While we are waiting for better studies, we are encouraged by the lack of biological plausibility of harm to the fetus and that mRNA does not get incorporated into the DNA,” says Eckert, who also consults for the World Health Organization (WHO).

Weighing the Benefits and Risks of Getting a COVID-19 Vaccine While Pregnant

There are 20 million healthcare workers and 100 million people with high risk medical conditions living in the U.S. However, the national four-phased approach for equitable vaccine distribution doesn’t specifically call out “pregnancy” or the order in which healthcare workers should be prioritized. As we’ve seen with other recommendations during the pandemic, each state and hospital vaccination site is taking a slightly different approach in how they choose to implement the guidance and allocate their limited supply.

“The risk and benefit analysis is a complicated one for patients,” Sonia Khan, BSc, MD, FAAP, a pediatrician and Commissioner of the Human Relations Commission (HRC) for the city of Fremont, California, tells Verywell. She’s been actively participating on CDC partner calls as a member of the AAP Council on Children & Disasters and recommends pregnant women should take the following into consideration when making a decision on whether or not to get a COVID-19 vaccine:

  • local conditions and community prevalence of COVID
  • personal risk and any professional exposure (or that of family members in proximity)
  • medical risks and any comorbidities  
  • known efficacy in non-pregnancy
  • known side-effects in non-pregnancy
  • absence of direct data

“I personally believe the decision to get vaccinated has to be between the provider and the patient,” Sasha Yep, a nurse practitioner currently 24 weeks pregnant with her third child, tells Verywell.

Yep transitioned to a work-from-home position as a phone triage nurse for a midwestern healthcare company during the pandemic and considers herself at a lower risk than her peers working in hospital settings while pregnant. “I still think all pregnant healthcare workers should talk with their OB-GYN to assess the status of their pregnancy, their health, weight and development of the fetus, any allergies, and past reactions to vaccines before getting a COVID-19 vaccine through their employer."

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  8. Society for Maternal-Fetal Medicine. Society for Maternal-Fetal Medicine (SMFM) statement: SARS-CoV-2 vaccination in pregnancy. Updated December 1, 2020.

  9. Duke University School of Medicine. Duke Ob/Gyn team publishes "COVID-19 Vaccines in Pregnancy" in AJOG-MFM. Updated December 7, 2020.

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  11. National Academy of Sciences, Engineering and Medicine. National Academies release framework for equitable allocation of a COVID-19 vaccine for adoption by HHS, state, tribal, local, and territorial authorities. Updated October 2, 2020.