Tthe arrival of Covid-19 vaccines at the hospital where I work feels like a glimmer of hope, a slight relief from the daily anxiety of feeling exposed and vulnerable while caring for patients.
However, when the time came for my appointment, I hesitated. As a physician, I understand and respect the privilege of being among the first group in the United States to be offered the vaccine. But as a pregnant woman, I was left to interpret vague guidelines developed without data from clinical trials on people like me. I finally decided to get the vaccine, like other pregnant health professionals, although I feel anxious about making this decision without sufficient information about its effectiveness and safety for me and my baby.
The first Covid-19 vaccine trials excluded pregnant people, as did most clinical trials, ostensibly to protect against possible unknown harm to the person or fetus. The FDA also needs additional tests to study a treatment during pregnancy, so it’s a matter of benefits to exclude pregnant people. However, the failure to exclude pregnant people 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 test their vaccination in pregnant women is good news, but it will not help those who are being vaccinated now.
The World Health Organization recently recommended its position to recommend against Covid-19 vaccination in pregnant people, but the current language still lacks it. Other published recommendations were equally ambivalent, such as the American College of Obstetricians and Gynecologists’ recommendation that “vaccines should not be withheld from pregnant individuals.” The Centers for Disease Control and Prevention website provides this careful guide:
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‘Based on current knowledge, experts believe that mRNA vaccines are unlikely 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 to the pregnant person and the fetus are unknown because these vaccines have not been studied in pregnant people. ‘
When I decided to be vaccinated against Covid-19 without a confirmatory recommendation, I made myself feel vulnerable and not protected. But it does not have to be this way for others. The country has the opportunity to study the safety and efficacy of the vaccine among pregnant health professionals who choose to get it now. But I am afraid that the opportunity is lost without following it systematically.
When I got my Covid-19 vaccine, I was instructed to scan a QR code on a poster. This brought me to V-safe, a CDC vaccine detection system. One of the questions I answered at each dose was, “Were you pregnant during your vaccination against Covid-19?” to which I answered ‘Yes’, and expect to ask a series of other questions about my pregnancy. I was not.
Instead, I only answered questions about arm pain, fatigue, and fever. I was waiting for an email or phone call asking me to sign up for pregnant people receiving the vaccine. Instead, silence. Why is no one asking us for more information?
Randomized clinical trials such as the Pfizer / BioNTech thesis, in which some volunteers were randomly assigned to receive treatment and others were not, are the gold standard for studying new medical therapies. But there is another way to get useful, timely information on the intersection of vaccination and pregnancy with Covid-19. The cadre of pregnant health workers who are already receiving the vaccinations is a natural group, a group of people with a certain exposure that can be followed over time for outcomes of importance such as antibody formation, Covid-19 infection and pregnancy complications.
This type of observational study would not provide the kind of information normally required for the FDA’s formal approval of a drug or vaccine, but it would provide meaningful information to pregnant individuals and their providers who need to make decisions about the vaccine. now. Looking at such a study high and low, I found that one award was recently issued to researchers who intend to detect individuals who have been vaccinated against Covid-19 over a period of five years.
I know several pregnant health professionals who have already received Covid-19 vaccines. I can only imagine how many thousands of us there are in the country’s health systems. We are in the position to choose to be vaccinated without data, but those who come after us do not have to be.
The CDC already has systems in place to monitor the safety of vaccines, and needs to leverage this national infrastructure to go beyond basic reporting on adverse events for pregnant health workers who are now being vaccinated against Covid-19. People like me can provide important, timely information about the vaccine during pregnancy if there is only one system to do so.
Healthcare workers are excellent participants in the study. Really. Ask us to sign up.
Catherine Mezzacappa is a family physician at Yale New Haven Hospital with a background in public health research. The opinions presented here are from her and not necessarily from her employer.