The race for a coronavirus vaccine continues, and researchers have made significant progress in recent weeks. But as of now, pregnant people haven’t been included in any clinical trials. The Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) are leaving it up to expectant parents—including pregnant healthcare workers—to decide for themselves whether to get vaccinated. We spoke with experts to learn everything you need to know about the COVID-19 vaccine for pregnant people.
Why Aren't Pregnant Women Included in COVID-19 Vaccine Trials?
Before a COVID-19 vaccine is released to the public, it has to undergo strict testing through the FDA. The White House’s Operation Warp Speed, which aims to deliver 300 million vaccine doses by January 2021, has been helping researchers complete clinical trials in record time. The trials mainly include healthy adults without underlying health conditions, according to Christine Turley, M.D., Pediatrics Specialist and vice chair of research at Atrium Health Levine Children’s. As of now, pregnant women have been completely excluded.
It’s actually the norm for expectant parents to be left out of clinical trials. “Pregnant women are a complex group of individuals to include in any research,” says Dr. Turley, adding that pregnancy itself is considered an “immunocompromised state.” Experts simply don’t understand the risks to the fetus, and they don’t want to put any lives in danger.
“Usually trials with [pregnant women] start later, after deemed safe in other groups,” explains Purvi Parikh, M.D., an allergist and immunologist with the Allergy and Asthma Network and co-investigator on the vaccine trials. “I hope as we get more safety data, pregnant women are included in trials.” In fact, Pfizer and Moderna may conduct formal trials with pregnant woman as early as the first quarter of 2021, says New York Magazine. Pfizer also reports that preliminary studies on pregnant animals have been promising.
What Are the Downsides to Excluding Pregnant Women?
While researchers are trying to keep pregnant people safe, many OB-GYNs are concerned about their exclusion from clinical trials. “Emerging data suggests that pregnant women are more likely to experience severe disease from COVID-19,” says Lorene Temming, M.D., Medical Director of Labor and Delivery, maternal-fetal medicine specialist, and Director of the Medical Student Clerkship program at Atrium Health.
Indeed, a Morbidity and Mortality Weekly Report (MMWR) from the Centers for Disease Control and Prevention (CDC) studied COVID-19 symptoms in women aged 15-44 years. Researchers found that “intensive care unit admission, invasive ventilation, extracorporeal membrane oxygenation, and death were more likely in pregnant women than in nonpregnant women,” according to the report. Dr. Temming adds that COVID-19 might also increase the chances of miscarriage, preterm birth, and pregnancy complications.
Given this information, it makes sense that pregnant women should have access to a vaccine ASAP. It could decrease the risk of dangerous complications, potentially saving the lives of mothers and their babies. That’s why so many healthcare experts are pushing for the inclusion of pregnant people in the trials. Similarly, the American College of Obstetricians and Gynecologists (ACOG) "recommends that COVID-19 vaccines should not be withheld from pregnant individuals who meet criteria for vaccination based on ACIP-recommended priority groups," according to its website.
When Will a Vaccine Be Available for Pregnant Women?
One of the vaccine frontrunners (Pfizer) was granted emergency use authorization from the FDA, and others may soon follow suit. Emergency use authorization makes the vaccine available to high-risk individuals, such as healthcare workers and the elderly. Assuming everything goes well in subsequent testing and research, the vaccine should receive final FDA approval a few months later, which would approve it for widespread community use.
Many experts, including Dr. Turley and Dr. Parikh, are hopeful that a vaccine will be ready for the public in the middle of 2021. It’s possible that the vaccine will also be approved for pregnant women at this time.
“Hopefully, as we learn more, pregnant women can be included in trials,” says Dr. Parikh. “But given the public health threat, we may have to recommend or vaccinate pregnant women without all of the data, since the benefits of the vaccine outweigh risks of infection. We may have [to make decisions] based on data from women of childbearing age who are not pregnant, or data from trial participants who accidentally become pregnant in the trials.” Pregnant healthcare workers who get vaccinated might also serve as an example.
How to Protect Against COVID-19 in Pregnancy
Whether or not pregnant women decide to receive the COVID-19 vaccine, there are ways to limit exposure to the virus. Perhaps the best prevention method, says Dr. Temming, is creating a “bubble of protection” around expectant parents. This means that partners, family members, and other close contacts should be vaccinated, so if they’re ever exposed to the coronavirus, they have a smaller chance of transmitting it to the expectant parent.
Experts also stress the importance of other COVID-19 prevention methods: social distancing, wearing masks in public places, washing your hands, and avoiding unnecessary activities. “Make sure you are in the best health possible so that if you do get sick, your body and immune system is able to fight it,” says Dr. Parikh. “This includes appropriate doctors visits, vitamins, getting other vaccines like the flu shot, and proper sleep and nutrition.”
So, Should Pregnant People Get the COVID-19 Vaccine?
Hopefully when the COVID-19 vaccine becomes available to the public, we'll have a lot more information about how it impacts pregnant people. For now, expectant parents must make the decision for themselves. If you're still unsure, check out this guide from the ACOG, which gives pointers for talking to your healthcare provider about vaccine considerations.