Pregnant people’s exclusion from clinical trials means we’re missing important information on the safety and efficacy of the vaccine in that potentially high-risk group.
After months of clinical trials, a COVID-19 vaccine appears to be just around the corner. On December 11, Secretary of Health and Human Services, Alex Azar, said the FDA plans to authorize the Pfizer vaccine, and the first shots could be administered as early December 14 or 15.
“Just a little bit ago the FDA informed Pfizer that they do intend to proceed towards an authorization of their vaccine,” Azar told Good Morning America. “We should be seeing the authorization of this first vaccine and… we will work with Pfizer to get that shipped out. We could be seeing people getting vaccinated Monday or Tuesday of next week.”
The Centers for Disease Control and Prevention (CDC) has adopted a recommendation to give the vaccine to health care workers and residents of long-term care facilities before anybody else, since both groups are at an increased risk for contracting the illness, or for developing sever consequences from it.
But what about pregnant people? A Morbidity and Mortality Weekly Report (MMWR) study found that they, too, at increased risk for severe illness from COVID-19, though less so than 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 means that even when the vaccines are authorized by the FDA for use in the US, they won’t be recommended for pregnant people. 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.”
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.”
Dr. Zahn added that the ACOG will continue to monitor data and recommendations as they become available and release guidance for members “as soon as enough information is available from FDA and ACIP to adequately inform recommendations for the use of these impending vaccines in pregnant and lactating patients.”
It should be noted that the UK, the first country to approve the Pfizer vaccine, has taken a similar stance regarding pregnant people. In what the UK government describes as a “precautionary approach,” the Joint Committee on Vaccination and Immunisation (JVCI) has advised that pregnant people don’t get the vaccine due to a lack of data on safety. They’ve extended that advice to people who think they may be pregnant and people who are planning a pregnancy within three months of the first dose of the vaccine.
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. The committee said that further considerations around use of COVID-19 vaccines in pregnant or breastfeeding health care workers “will be provided once data from phase III clinical trials and conditions of FDA Emergency Use Authorization are reviewed.”
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.
However, in a discussion during Columbia University’s Grand Rounds 2020 event, as reported by CNBC, Dr. Anthony Fauci shared that drugmakers and US regulators plan to launch clinical trials in January to test COVID-19 vaccines on pregnant people and children. Dr. Fauci, the director of the National Institute of Allergy and Infectious Diseases, said that the trials won’t necessarily be looking at efficacy, but rather safety and immunogenicity [the vaccine’s ability to provoke an immune response] in those two populations, “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 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, are kind of in a watchful waiting phase right now. 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.
Sherry Ross, MD, OB/GYN and women’s health expert at Providence Saint John’s Health Center in Santa Monica, California, says there’s just not enough medical research to ensure that pregnant people and their unborn babies are safe from any harmful effects of the new COVID-19 vaccines. “At this point, there’s too much uncertainty about the safety of the COVID-19 vaccine and pregnant [people].”
Overall, the Society for Maternal-Fetal Medicine (SMFM) released a statement Tuesday encouraging expecting parents to “engage in shared decision-making” about the vaccine with their doctors.
“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.
The best way to protect pregnant people from getting the COVID-19 virus is to follow the CDC’s advice and practice social distancing, avoid indoor gatherings and wear masks—and that goes for everybody, not just the pregnant people themselves. “Reducing cases of COVID-19 in the general population is still the smartest strategy to protect pregnant [people] from this unpredictable and potentially deadly virus,” Dr. Ross says.
There’s also the question of herd immunity possibly protecting pregnant people down the line, but we’re still a long way from that. The nation’s leading infectious disease expert, Dr. Anthony Fauci, says at least 75% of people would need to be vaccinated or infected to produce herd immunity.
Of course, there may be people who receive the vaccine and are unaware that they’re pregnant. During a JAMA Network Conversations with Dr. Bauchner episode, Paul A. Offit, MD, from the Children’s Hospital of Philadelphia, pointed out that “you never actually exclude pregnant people from studies because there are people that didn’t know they were pregnant that entered the study… so there will be at least some data in those.” He also said that the CDC’s new Vaccine Safety Assessment for Essential Workers (V-SAFE) app will track everyone who gets the vaccine for adverse reactions, including people who don’t know they’re pregnant when they get the vaccine.
But at this very moment, we just don’t know for sure whether the COVID-19 vaccine is safe for pregnant people or when they will be offered the vaccine.
“At present, there isn’t a simple answer to questions about whether pregnant people, or those considering pregnancy, should receive the COVID-19 vaccine, but ACOG feels strongly that the vaccine should not be withheld from pregnant individuals,” Dr. Zahn said. “Any decisions made should be based on any available data and recommendations for use in pregnancy, patients’ individual risk factors and the potential benefits, and their unique needs, desires, and values.”
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.
By Claire Gillespie | Source