- The Centers for Disease Control and Prevention recommends that pregnant individuals receive a COVID-19 vaccine.
- 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.
- Preliminary research did not find any obvious safety concerns for pregnant individuals who received the Moderna or Pfizer COVID-19 vaccines or their babies.
On April 23, 2021, the Centers for Disease Control and Prevention (CDC) announced that it is recommending that people who are pregnant receive a COVID-19 vaccine.
The recommendation, which was announced by CDC Director Rochelle Walensky at a White House press briefing, follows preliminary research published in The New England Journal of Medicine that tracked more than 35,000 pregnant individuals who received the mRNA COVID-19 vaccines (Pfizer or Moderna) and did not find any obvious safety concerns for pregnant individuals or their babies.
The data in the study was collected through the CDC and Food and Drug Administration (FDA) monitoring systems and a CDC vaccine registry, which is ongoing. Most people in the preliminary analysis were in their third trimester when they received the vaccines, and researchers noted that additional monitoring is needed, including for those vaccinated during earlier stages of pregnancy and preconception.
The study did not include the Johnson & Johnson (Janssen) COVID-19 vaccine since data was collected from December to February and the Johnson & Johnson vaccine received an emergency use authorization (EUA) on February 27, 2021. The Pfizer-BioNTech COVID-19 vaccine was granted emergency use authorization (EUA) from the Food and Drug Administration (FDA) on December 11, 2020, and the Moderna COVID-19 vaccine received an EUA on December 18.
Prior to the CDC announcement, the CDC and FDA had stated that individuals who are pregnant or breastfeeding should be allowed to receive the vaccines, but the agencies did not offer any direct recommendations due to the lack of research. For example, the FDA’s EUA for the Pfizer COVID-19 vaccine, states “if you are pregnant or breastfeeding, discuss your options with your healthcare provider.”
According to the CDC, there is no evidence that COVID-19 vaccination causes any problem with pregnancy, including the development of the placenta, and pregnant people experience the same side effects following vaccination as those who aren’t pregnant.
“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 Get Meds Info. 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.”
ACOG recommends that pregnant and breastfeeding individuals 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 intensive care unit (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 people 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 Get Meds Info. “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 initially included in COVID-19 trials—including those from Pfizer-BioNTech, Moderna, Johnson & Johnson, 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 the Society for 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 they and their healthcare providers engage in “shared decision-making” regarding the vaccine.
As of their December 10, 2020 meeting on an EUA for the Pfizer-BioNTech COVID-19 vaccine, FDA was still awaiting the results of animal studies on developmental and reproductive toxicity. But those experiments on rats using the Pfizer and Moderna vaccines did not show any harmful effects for pregnancy or fetal development. The CDC is also funding research at Duke University on pregnant women who choose to receive the COVID-19 vaccine.
Following the positive results of the animal research, Pfizer announced on February 18, 2021, that a trial of the Pfizer vaccine in pregnant women, which will enroll about 4,000 people, began administering doses. It is the first COVID-19 trial in pregnant women.
Moderna has launched a registry to track pregnant individuals who opt to be vaccinated.
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.
Are COVID-19 Vaccines 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 from Pfizer’s trial of pregnant women, but for now we have the preliminary research on mRNA vaccines in more than 35,000 pregnant people that did not find any safety concerns and was published in the peer-reviewed and highly respected New England Journal of Medicine.
In addition, the research on the Pfizer vaccine’s safety and efficacy (excluded pregnant people) included almost 44,000 people and found it to be 95% effective at preventing COVID-19. Some women in Pfizer-BioNTech’s trials did become pregnant over the course of the previous trials and experienced no ill effects.
Shannon Rotolo, PharmD, BCPS, a pharmacist at the University of Chicago Medical Center, tells Get Meds Info 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.
A study of 84 pregnant people published in the journal Obstetrics & Gynecology found no evidence of any injuries to the placenta after COVID-19 vaccination.
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 Johnson & Johnson vaccine is a viral vector vaccine that uses a weakened adenovirus (common cold) as the vector (delivery method) for a recombinant vaccine. Recombinant vaccines use a small piece of genetic material from the virus to create an immune response.
Both the mRNA and viral vector vaccines:
- Are not live vaccines, which means there is zero risk of inducing or transmitting COVID-19 through vaccination
- Do not enter the cell nucleus
- Do 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).
The delivery method for the Johnson & Johnson’s COVID-19 vaccine has been used in other development programs that have included pregnant people, including in a large-scale Ebola vaccination trial, that did not find any adverse pregnancy or infant outcomes. However, the FDA and CDC want women, especially those under age 50, to be aware of a rare but serious blood clotting condition that can occur after vaccination with the Johnson & Johnson vaccine.
Weighing the Benefits and Risks of Getting a COVID-19 Vaccine While Pregnant
A preliminary study published in the American Journal of Obstetrics & Gynecology included people who were pregnant (84 participants) or breastfeeding (31 participants) when they received the mRNA vaccines and found a robust immune response in the individuals plus antibodies in their umbilical cord blood or breast milk. Much larger studies are needed, but this small sample suggests that vaccination while pregnant or lactating may offer some fetal and infant protections.
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.
“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 Get Meds Info. 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 Get Meds Info.
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.”
The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.