We need to enroll pregnant women in clinical trials for the coronavirus vaccines
The World Health Organization, which is not the guiding authority in the United States, at first said only women at high risk of getting covid-19 should get injected with the Moderna and Pfizer vaccines, only to shift later to guidance more in line with U.S. recommendations after an outcry from doctors, patients and medical organizations.
Leading organizations representing the health of women, such as March of Dimes and the American College of Obstetricians and Gynecologists, say the vaccine should not be withheld from women who fall into one of the CDC advisory committee’s high-risk groups.
White House health adviser Anthony S. Fauci says there are “no red flags” regarding the safety of the approved vaccines for the 10,000 pregnant women who have been vaccinated so far. That’s great news, but might not sound like 100 percent certainty to a woman’s ears if she knows that pregnant women were excluded from initial Phase 1 and Phase 2 vaccine trials.
Barring pregnant women from early clinical trials out of fear for their safety and the safety of their fetuses puts the onus on pregnant women and their doctors to weigh the risks and benefits of the vaccine without definitive evidence — and that’s not fair.
Our past mistakes must not deter pregnant women from getting vaccinated. But they must become the impetus for change.
Excluding pregnant women from trials has long been a common practice, in part because of concerns about safety for women and their fetuses and liability for those conducting the trials. But during pregnancy, women end up using drugs and vaccines that have not been tested on pregnant people.
When it came to conducting the early clinical trials for the covid-19 vaccines, the drug companies were following Food and Drug Administration protocol, which excludes pregnant women from drug development clinical trials, except in situations where it is “ethically appropriate,” meaning pregnant women have a need for the drugs and there is evidence from animal trials pointing to its safety.
The FDA required the companies developing covid-19 vaccines to first conduct toxicity studies in pregnant rats, which showed no adverse effects. The rat studies gave us a good degree of confidence that the vaccines are safe, but to date there have still been no clinical trials testing the vaccines on pregnant women. Pfizer’s trials on pregnant women have not yet begun, and Moderna is compiling a registry of women who are vaccinated to track efficacy and side effects after the fact.
I am eager to get my covid-19 shot when my turn arrives, and I want pregnant women to get vaccinated when doses are available to them. A CDC analysis of national covid-19 data as well as a study of women in Washington state have shown pregnant women, while not more at risk for contracting covid-19, are more likely than others to be hospitalized or die if they get it. In addition to Pfizer and Moderna’s toxicity studies, our knowledge of mRNA vaccines weigh on the side of safety. But it shouldn’t be up to every doctor to explain to patients that the vaccines are safe, or to patients to research and then agonize over a decision.
What we need next is for the Department of Health and Human Services to work with Pfizer, Moderna and other drug companies to quickly enroll pregnant women in clinical trials.
In addition, the CDC’s v-safe vaccination tracking registry enables it to monitor pregnant women who have already been vaccinated, just as it does for other vaccines. It is a rigorous, tested and illuminating system. Women can contribute to science by registering using their cellphones. This data will enable researchers, doctors and pregnant women to begin to understand how safe the vaccine is in actual use.
There are enough things to worry about during a pandemic pregnancy. Whether to take a lifesaving vaccine shouldn’t be one of them.
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