Can Pregnant People Safely Get the COVID-19 Vaccine? Here’s Everything We Know So Far
Even though COVID-19 vaccines are now being administered to everyone 16 or older, there are still some questions surrounding whether or not pregnant women should get the vaccine. The Centers for Disease Control and Prevention (CDC), the American College of Obstetricians and Gynecologists (ACOG), and the American Academy of Pediatrics have all said that the vaccine should not be withheld from pregnant women. But at the same time, researchers note that information is limited on the vaccines' safety in pregnancy. Now, a new study from the CDC is shedding some light on that.
On April 21, the New England Journal of Medicine published the study, which showed that there were no "obvious safety signals" among the 35,691 pregnant participants who had received either the Moderna or Pfizer vaccines (the study did not look at the J&J vaccine). In other words, the women in the study experienced complications like miscarriage, premature births, small size for gestational age, congenital disorders, and newborn death in a similar proportion to pregnant women before the pandemic.
While promising, the CDC points out that more research needs to be done to "further assess maternal, pregnancy, neonatal, and childhood outcomes associated with maternal COVID-19 vaccination, including in earlier stages of pregnancy and during the preconception period." Still, the CDC says that the new data can help pregnant women and their health care providers in making informed decisions about getting vaccinated.
Pregnant women may be at an increased risk for COVID complications
A Morbidity and Mortality Weekly Report (MMWR) study published in November found that they, too, are at increased risk for severe illness from COVID-19, though less so than those in other high-risk groups. The study found that pregnant people are more likely to be admitted to the intensive care unit (ICU), receive invasive ventilation and extracorporeal membrane oxygenation (the use of an artificial lung located outside the body that puts oxygen into the blood), and are at increased risk of death compared to non-pregnant people. The CDC has also warned that pregnant people with COVID-19 might be at increased risk for other adverse outcomes, such as preterm birth.
So that means pregnant people should get the vaccine too, right?
Unfortunately, it's not quite as simple as that. Pregnant people haven't been actively involved in late-stage clinical trials for any COVID-19 vaccines, including the Pfizer and Moderna vaccines. This lack of data resulted in the FDA not recommending the vaccines for pregnant people when they were first approved for use in the US. On December 2, the Advisory Committee on Immunization Practices (ACIP), the CDC's independent advisory council, also noted that there is currently "no data on the safety and efficacy of COVID-19 vaccines in [pregnant or breastfeeding people] to inform vaccine recommendations."
In late January, WHO released a statement that reiterated the lack of data on pregnant women receiving the COVID-19 vaccine. However, the next day, ACOG and the Society for Maternal-Fetal Medicine (SMFM) released a joint statement that seemed to muddy the waters. The statement, published January 27, reads: "The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal Fetal Medicine (SMFM) are aware of the World Health Organization's (WHO) recommendation to withhold COVID-19 vaccines from pregnant individuals unless they are at high risk of exposure. ACOG and SMFM continue to stress that COVID-19 vaccines currently authorized by the US Food and Drug Administration should not be withheld from pregnant individuals who choose to receive the vaccine."
"In general, SMFM strongly recommends that pregnant [people] have access to COVID-19 vaccines in all phases of future vaccine campaigns, and that she and her health care professional engage in shared decision-making regarding her receipt of the vaccine," the society said. It also pointed out that the first available COVID-19 vaccines are likely to be mRNA vaccines, which don't contain a live virus but basically "trick" the body into producing some of the virus's molecules itself. According to SMFM, the theoretical risk of fetal harm from mRNA vaccines is "very low," and health care professionals should communicate this to their patients.
Christopher Zahn, MD, vice president of Practice Activities for the American College of Obstetricians and Gynecologists (ACOG), told Health in an emailed statement that the ACOG had "urged the US Food and Drug Administration as well as the Advisory Committee on Immunization Practices to address use of the vaccine on pregnant and lactating individuals."
There's also the question of pregnant health care workers and whether they can or should get the vaccine. The ACIP has raised the point that due to the predominance of people of child-bearing potential among the health care workforce, a substantial number of health care workers are estimated to be pregnant or breastfeeding at any given time.
Taking everything that has been learned in the past year into account, the American Society for Reproductive Medicine has developed its own recommendation. On April 20, the group released a statement saying that "everyone, including pregnant women and those seeking to become pregnant, should get a COVID-19 vaccine. The vaccines are safe and effective."
Is it common to exclude pregnant people from clinical trials?
Plainly, yes. In 2018, researchers writing for Trials said pregnant woman are "severely underrepresented in clinical research" and recommended the inclusion of pregnant people "at the earliest phases of the research process."
The ACOG has also long advocated for pregnant and lactating people to be included in clinical trials to provide the safety and efficacy data needed to let expectant moms make an informed decision regarding vaccination, Dr. Zahn said.
"Since the summer, ACOG has advocated for pregnant patients who fall into an ACIP-identified high-priority group to have the freedom to make their own decisions regarding receipt of [the COVID-19] vaccine in conjunction with their clinical care team," Dr. Zahn said.
And it looks like more data on COVID vaccines in pregnancy will be coming. Pfizer and Johnson & Johnson have both said that they have or will be starting clinical trials for their vaccines that include pregnant women. However, in a discussion during Columbia University's Grand Rounds 2020 event, as reported by CNBC, Dr. Anthony Fauci shared that the clinical trials that drugmakers and US regulators plan to launch this year won't necessarily be looking at efficacy. Dr. Fauci, the director of the National Institute of Allergy and Infectious Diseases, said that, rather the trials will most likely concentrate on the safety and immunogenicity [the vaccine's ability to provoke an immune response] in the population, "to bridge to the efficacy in the adult non-pregnant population."
But what about other vaccines—pregnant people get those, don't they?
Yes, some vaccines are known to be safe during pregnancy. "Flu vaccines are recommended in pregnancy—and have been for a very long time," Dr. Brightman says. The CDC advises pregnant people to get the flu shot at any time during their pregnancy to help protect them and their baby. The same goes for the whooping cough vaccine, which should be administered early in the third trimester. However, despite the CDC recommendations, only 1 in 4 pregnant people in the US get both the flu and whooping cough vaccines.
The difference is that lots of studies have shown these vaccines to be safe during pregnancy (for both mom and baby), but we still don't have that same amount of data for the COVID-19 vaccine.
So what do ob-gyns think of this—and what should pregnant people do right now?
Clinicians in the maternal health field are, like pregnant people, kind of in a watchful waiting phase right now as information about the COVID-19 vaccine and pregnancy continues to roll out. Rebecca C. Brightman, MD, a gynecologist in private practice in NYC and an assistant clinical professor of obstetrics, gynecology, and reproductive Medicine at the Icahn School of Medicine at Mount Sinai, tells Health that she's received no information about the COVID-19 vaccination during pregnancy or in relation to pregnancy planning. "We'll follow guidelines from the American College of Obstetricians and Gynecologists (ACOG) when these are issued," Dr. Brightman says. (Note: Though the ACOG and FSM have only issued the recommendation that the COVID-19 vaccine not be withheld from pregnant women, more concrete guidelines have yet to be released.)
But experts are hopeful that the newest data from the CDC will help those in the health care field to make better informed decisions based on the need of their pregnant patients. "I think we can feel more confident about recommending the vaccine in pregnancy, especially with pregnant people that are at risk of COVID," Stephanie Gaw, MD, a maternal-fetal specialist at the University of California, San Francisco, told The New York Times. But, she added, "we do need to wait for more data for complete pregnancy outcomes from vaccines early in pregnancy."
For right now, the best way to protect pregnant people who, for whatever reason, do not get the COVID-19 vaccine, is for everyone to continue following the CDC's advice for both vaccinated and unvaccinated people, like avoiding large indoor gatherings, wearing masks in public, Sherry Ross, MD, OB/GYN and women's health expert at Providence Saint John's Health Center in Santa Monica, California, tells Health. There's also the possibility of herd immunity protecting pregnant people down the line, but we're still a long way from that. Dr. Fauci says at least 75% of people would need to be vaccinated or infected to produce herd immunity.
And if you are pregnant and interested in getting the COVID-19 vaccine, that is your choice, according to the CDC. While the agency says it may be helpful to have a conversation with your health care provider to help you decide, it is not required prior to vaccination. If you choose to get vaccinated as a pregnant person, you can help experts continue to refine their recommendations for other pregnant people by reporting any possible side effects or health problems that may happen after the vaccine by reporting those to the agency's Vaccine Adverse Event Reporting System (VAERS) or the CDC's V-safe COVID-19 Vaccine Pregnancy Registry.
The information in this story is accurate as of press time. However, as the situation surrounding COVID-19 continues to evolve, it's possible that some data have changed since publication. While Health is trying to keep our stories as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDC, WHO, and their local public health department as resources.
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