TThe arrival of the Covid-19 vaccines at the hospital where I work was like a glimmer of hope, a little relief from the daily anxiety of feeling exposed and vulnerable when caring for patients.
When it came time for my appointment, however, I hesitated. As a doctor, I understand and respect the privilege of being among the first group in the United States to receive the vaccine. But as a pregnant woman, I was trying to interpret vague guidelines developed without clinical trial data on people like me. Finally, I decided to get the vaccine, like other pregnant health professionals, despite feeling anxious to make this decision without adequate information about its effectiveness and safety for me and my baby.
The first trials of the Covid-19 vaccine excluded pregnant women, as well as most clinical trials, apparently to protect against possible unknown damage to the person or fetus. The FDA also requires additional testing to study treatment during pregnancy, so excluding pregnant women becomes a matter of convenience. However, the pattern of excluding pregnant women from clinical trials forces them to make treatment decisions without the necessary information.
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The announcement on Thursday that Pfizer / BioNTech will conduct a test of its vaccine on pregnant women is good news, but it will not help those being vaccinated now.
The World Health Organization recently revised its stance recommending against vaccination with Covid-19 in pregnant women, but its current language still does not recommend it. Other published recommendations have been equally ambivalent, such as the American College of Obstetricians and Gynecologists’ recommendation that “vaccines should not be denied to pregnant women”. The Centers for Disease Control and Prevention website offers this cautious guidance:
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“Based on current knowledge, experts believe that mRNA vaccines are not likely to pose a risk to the pregnant person or the fetus because mRNA vaccines are not live vaccines. … However, the potential risks of mRNA vaccines for the pregnant person and the fetus are unknown because these vaccines have not been studied in pregnant women. “
Choosing to be vaccinated against Covid-19 without an affirmative recommendation made me feel vulnerable, not protected. But it doesn’t have to be that way for others. The country has the opportunity to study the safety and efficacy of the vaccine in pregnant health professionals who are choosing to receive it now. But I fear that this opportunity is being lost without a systematic effort to track them down.
When I received my Covid-19 vaccine, I was instructed to scan a QR code on a poster. This led me to V-safe, a CDC vaccine safety tracking system. One of the questions I answered with each dose was: “Were you pregnant at the time of the Covid-19 vaccination?” to which I replied “Yes”, expecting to be asked a series of other questions about my pregnancy. I was not.
Instead, I answered only routine questions about arm pain, fatigue, and fever. I waited for an email or phone call inviting me to enroll in a study with pregnant women who received the vaccine. Instead, silence. Why is no one asking us for more information?
Randomized clinical trials such as Pfizer / BioNTech, in which some volunteers are randomly assigned to receive treatment and others are not, are the gold standard for studying new medical therapies. But there is another way to get useful and timely information about the intersection of Covid-19 vaccination with pregnancy. The group of pregnant health professionals who are already receiving the vaccines forms a natural cohort, a group of people with a certain exposure that can be followed over time for results of interest, such as antibody formation, Covid-19 infection and complications in pregnancy.
This type of observational study would not provide the type of information generally required for formal FDA approval of a drug or vaccine, but it would provide meaningful information for pregnant individuals and their providers who need to make vaccine decisions. now. Searching high and low for this study, I found a grant recently awarded to researchers who plan to start tracking individuals who were vaccinated against Covid-19 during pregnancy for adverse results over a five-year period.
I know several pregnant health professionals who have received Covid-19 vaccines. I can only imagine how many thousands of us are in the country’s health systems. We were put in the position of choosing to be vaccinated without data, but whoever comes after us doesn’t have to be.
The CDC already has systems in place to monitor vaccine safety and should take advantage of this national infrastructure to go beyond basic notification of adverse events for pregnant healthcare professionals who are now being vaccinated against Covid-19. People like me could be providing vital and timely data about the vaccine during pregnancy if only there was a system for doing so.
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Catherine Mezzacappa is an internal medicine resident doctor at Yale New Haven Hospital with experience in public health research. The opinions presented here are hers and not necessarily those of your employer.