May 27, 2021
When the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) approved the coronavirus vaccine to be administered in the U.S., it came with several caveats and restrictions, but arguably none more confounding than the recommendation for pregnant women. While pregnant women are more likely to get severe symptoms from the virus, they were excluded from the original vaccine trials and so have not been “officially” authorized to receive it. Many experts believed the vaccine to be safe for pregnant women, however, and urged the FDA to “leave the door open.” Ultimately the public health messaging has become this: The existing evidence suggests there won’t be any complications, but it’s up to you, pregnant people, to talk to your doctor and decide for yourselves.
Excluding pregnant women in medical trials has long been an issue. They are considered a more vulnerable population, so excluding them is conceivably a protective measure for both mother and fetus. But it can also mean excluding them from the sometimes life-saving preventions and treatments. In an op-ed for Scientific American, President and CEO of the Society for Women’s Health Research Kathryn Schubert wrote, “As a high-risk population, pregnant people clearly need access to vaccines and treatments for COVID-19 … To address these concerns, we must move toward protecting pregnant people through research, not from research.” She goes on to share recent recommendations from the Task Force on Research Specific to Pregnant Women and Lactating Women.
Early in the rollout, the 300,000 pregnant health care workers who had first access to the vaccines were faced with the worst dilemma — not just lack of data, but conflicting advice from medical authorities. While the CDC had issued more “flexible” guidance on administering the vaccine to pregnant people, the World Health Organization (WHO) recommended against it, and the U.K. even banned it. The conflict was rooted in the lack of data. After experts expressed disappointment at WHO, the global health agency reversed its advice to more closely align with the CDC stating, “Based on what we know about this kind of vaccine, we don’t have any specific reason to believe there will be specific risks that would outweigh the benefits of vaccination for pregnant women.”
Still, many news outlets characterized the decision for pregnant people as “agonizing,” with one Washington Post article sharing that online forums such as What to Expect erupted with a range of reactions. While one commenter noted, “I would not risk putting my baby in danger,” others were more confident in the choice to receive the vaccine. To help allay fears, several pregnant medical professionals penned op-eds as to why they decided to receive the vaccine. “My first instinct was I can’t get the vaccine because there are too many unknowns. But then I had to ask myself: What am I so worried about?” wrote emergency room physician Dr. Lauren Westafer, who had to decide in December if she’d get the vaccine.
By February, 10,000 pregnant women had received the vaccine, reported Dr. Anthony Fauci. “Even though we don’t have good data on it,” he noted, “the data that we’re collecting on it so far has no red flags.” By March, 60,000 pregnant people had received the vaccine, and data published in the American Journal of Obstetrics and Gynecology found that the vaccines offer strong immune protection for people who were pregnant. In April, the data was so promising that CDC Director Rochelle Walensky shared that there were no safety concerns. And by May, two studies published in JAMA Pediatrics concluded that the shot was safe for pregnant women and even beneficial for their unborn children.
Formal vaccine trials for pregnant women are now underway. While the emerging data indicates that vaccines are both safe and beneficial for mom and baby, there are still no overt recommendations by the CDC, ultimately leaving the decision up to the pregnant woman and her doctor. To help our readers better understand the complicated story of pregnancy, clinical trials, and how we have come to a place where medical authorities use a “relaxed” approach to recommending the coronavirus vaccine to pregnant women, we have compiled a library of article links below. We hope you find this helpful if you are pregnant or supporting pregnant people deciding to receive the vaccine as this story continues to unfold.
Pregnancy and Vaccines
Salon: Coronavirus vaccines weren’t tested on pregnant women — here’s why that’s a problem
“Pregnant immune systems are a little different … we don’t have any direct data on whether it’s safe,” one doc said. (Karlis, 12/9/20)
STAT News: FDA: Leave the door open to Covid-19 vaccination for pregnant and lactating health workers
As the FDA develops its position, we urge it to consider more permissive language that acknowledges information gaps but still permits some high-risk pregnant or lactating individuals to get the vaccine. (Multiple Authors, 12/9/20)
The Washington Post: Medical research again leaves pregnant women waiting for a vaccine — this time for coronavirus
Around 70 percent of health-care workers worldwide are women, meaning many are on the front lines of the coronavirus pandemic and, in theory, toward the front of the line for a vaccine shot as they begin to be distributed. (Berger, 12/10/12)
The New York Times: Pregnant and Breastfeeding Women May Opt to Receive the Vaccine
Although no coronavirus vaccine has been studied in these women, many scientists believe the benefits will outweigh any potential risks. (Mandavilli, 12/11/20)
NPR: Pregnant People Haven’t Been Part Of Vaccine Trials. Should They Get The Vaccine?
The Food and Drug Administration is likely soon to authorize distribution of the Pfizer-BioNTech COVID-19 vaccine. But the vaccine trials have so far excluded pregnant people. (Wamsley, 12/11/20)
NBC News: Pregnant and nursing women await more guidance on Covid vaccine
Women who are pregnant or nursing were not included in clinical trials for the Covid-19 vaccine, though Dr. Anthony Fauci says those trials could begin in January. (Roller, 12/12/2020)
U.S. News & World Report: ACOG: Pregnant Women Should Have Chance to Get COVID-19 Vaccine
The vaccine should not be withheld from people who are pregnant or breastfeeding and who fall in prioritized categories, a key physicians group says. (Cirruzzo, 12/14/20)
New York Magazine: Should Pregnant People Take the Vaccine? FDA and CDC Say That’s Up to Them.
Over the weekend, after initial fears that pregnant and lactating health-care workers would be barred from receiving the COVID-19 vaccine because of a lack of safety data from clinical trials, the FDA and the CDC instead left the door open for them to choose. (Carmon, 12/14/20)
The Washington Post: Pregnant women agonize over whether to get coronavirus vaccine
For the first eight months of her pregnancy, Yadira Rivas, a nurse coordinator at Neighborhood Health of Virginia, relied on masks and gloves to protect her from the coronavirus that is rampant among her patients. (Sellers, 1/1/21)
NPR: Protect Pregnant Women ‘Through Research,’ Not ‘From Research,’ OB-GYNs Urge
Doctors who treat pregnant patients are finding themselves in a tough and familiar spot as the COVID-19 vaccines roll out: making decisions about the use of a particular medicine in this group of patients without any clinical evidence to guide them. (Mertens, 1/25/21)
The New York Times: Pregnant Women Get Conflicting Advice on Covid-19 Vaccines
The W.H.O. and the C.D.C. provide differing views, and experts partly blame a lack of data because expectant mothers have been excluded from clinical trials. (Mandavilli & Rabin, 1/28/21)
The New York Times: Pregnant Women May Receive Covid Vaccines Safely, W.H.O. Says
The World Health Organization on Friday changed its guidance for pregnant women considering a Covid-19 vaccine, abandoning opposition to immunization for most expectant mothers unless they were at high risk. (Mandavilli, 1/29/21)
Also featured in Axios (1/29/21), Business Insiders (Miller, 1/29/21)
The New Yorker: The Coronavirus Vaccine Presents a Dilemma for Pregnant Women
Vaccine trials have excluded the pregnant population, even though women of reproductive age make up a majority of frontline workers. (Sussman, 2/1/21)
USA Today: Should pregnant women get the COVID-19 vaccine? Dr. Anthony Fauci sees ‘no red flags’ in safety data
Some pregnant women remain unsure about getting the COVID-19 vaccine because safety data is scarce and health agency guidelines are vague and in some cases contradictory. (Rodriguez, 2/1/21)
Scientific American: Why COVID Vaccines Are Likely Safe for Pregnant People
The scantness of available data leaves the decision up to the individual and their doctors, though benefits can outweigh risks in some cases. (Lenharo, 2/2/21)
Bloomberg: Pregnant People Deserve Better Data on Covid-19 Vaccines
Why haven’t more researchers bothered to track this group? (Flam, 2/2/21)
Vox: Covid-19 vaccines are likely safe during pregnancy. When will we know for sure?
People who are pregnant or breastfeeding in the US could choose to get the vaccines, or wait until more data comes out this spring. (Courage, 2/3/21)
Bloomberg: Covid Vaccine For Pregnancy Trials To Begin As Pfizer-BioNTech Start Tests
Covid vaccine developers are beginning trials in pregnant women, looking to provide reassurance that the shots are safe for expectant mothers. Pfizer Inc. and German partner BioNTech SE dosed the first patients in a trial of their messenger RNA vaccine in 4,000 women in the latter stages of pregnancy, the companies said on Thursday. (Ring and Kresge, 2/18/21)
Also in The Hill (Castronuovo, 2/18/21), Reuters (Steenhuysen & Erman, 2/18/21), STAT (Mezzacappa, 2/19/21), and NBC (Edwards, 2/18/21)
The Hill: Vaccine research must include pregnant women during COVID and beyond
One thing is certain. If pregnant women had been included in studies of COVID-19 vaccines in a timelier manner, perhaps more of them would be planning to get vaccinated — and public health organizations would have been making consistent recommendations from the jump. (Williams, Phillips, & Wu, 3/3/21)
The Washington Post: Vaccinated Pregnant Women Pass Antibodies To Babies, Early Research Shows
Pregnant women who receive a coronavirus vaccine not only acquire protective antibodies against the virus for themselves but also may pass along immunity to their babies, emerging research shows. (Bever, 3/21/21)
Axios: Pfizer And Moderna COVID Vaccines Safe For Pregnant Women, Study Says
The Pfizer and Moderna vaccines are deemed safe and effective for pregnant women, according to a pre-print study out Thursday in the American Journal of Obstetrics & Gynecology. (Fernandez, 3/25/21)
NBC: Pregnant women show strong immune response to Covid vaccine, study finds
Research found the moms’ antibodies were present in their umbilical cord blood and breast milk, suggesting they pass on immunity to their babies. (Pawlowski, 3/25/21)
Forbes: Vaccinated Pregnant And Breastfeeding Women Could Pass Along Coronavirus Immunity To Their Babies, Study Suggests
Not only do coronavirus vaccines appear to provide immunity to pregnant and breastfeeding women with no additional risk of side effects, but the vaccine benefits may be passed on to their babies, suggests a new study of 131 women published in the American Journal of Obstetrics and Gynecology Thursday. (Porterfield, 3/25/21)
Also seen in CNN (Mascarenhas, 3/25/21), USA Today (Weintraub, 3/27/21), Romper (McGuire, 3/25/21)
The New York Times: No evidence that Pfizer or Moderna vaccines are unsafe during pregnancy, a preliminary study says.
In an early analysis of coronavirus vaccine safety data, researchers at the Centers for Disease Control and Prevention have found no evidence that the Pfizer-BioNTech or Moderna vaccines pose serious risks during pregnancy. (Anthes, 4/21/21)
Also seen in The Los Angeles Times (Tanner, 4/21/21)
CBS News: CDC reiterates guidance on safety of COVID-19 vaccines for pregnant people
The Centers for Disease Control and Prevention said Tuesday there is “growing evidence” about the safety of COVID-19 vaccines during pregnancy, and it reiterated its guidance on vaccinations for pregnant people, after it was asked to clarify a remark the CDC director made Friday about the recommendation. (Smith, 4/27/21)
The New York Times: Coronavirus Vaccines Protect Pregnant Women, Another Study Suggests
The shots may also have benefits for infants and do not seem to damage the placenta, according to the latest research. (Anthes, 5/13/21)
The Center for Health Journalism: Will the pandemic finally persuade researchers to test new drugs on pregnant women?
As in so many other areas, the COVID-19 pandemic has exposed the fractures in our status quo. A true assessment of a drug’s efficacy requires testing in pregnant women to determine if it is safe in utero. Yet this is rarely studied. (Sathe, 5/17/21)
