by Amie Devlin, MPH, MA
As a pregnant epidemiologist and bioethicist with an interest in clinical research, the development of the COVID-19 vaccines has been the equivalent of the Super Bowl to me. I can’t begin to count the number of times that I’ve explained to my husband over dinner the importance of sample size or debated the ethics of challenge trials. And if you had asked me two weeks ago about my feelings on offering the vaccine to pregnant people, I would have easily espoused the pros of our FDA review process, the differences between a theoretical risk and a proven risk, and the need to respect the autonomy of pregnant people.
I have always been a quantitative person and have prided myself in the ability to parse out relative versus absolute risk. I was the annoying friend at happy hours who would go on a rant if somebody mentioned that a risk “doubled” without also talking about the magnitude of the original risk. Yet here I am, fanatically reading news articles about the FDA’s decision to allow pregnant people to receive the vaccination, debating whether the benefits offset the risk, and deciding what I will say when I’m offered a COVID-19 vaccine. I understand the risks of getting COVID-19 while pregnant. I understand that there are no documented risks of vaccinating a pregnant person. But I also can’t stop myself from thinking, “What if I make the wrong choice?”
I’ve been comparing this decision to a modified Trolley Problem. Is it better to take no action and accept the (possible? inevitable?) harm of catching COVID naturally? Or is it better to get the vaccine, and know that any harmful consequences were the result of an intentional action rather than random chance? And how does this risk-benefit analysis change as others around me get the vaccine? Does a more vaccinated population provide more protection as we approach herd immunity? Or does a more vaccinated population lead to a false sense of security, where people no longer feel compelled to wear masks at the grocery store?
In breaking with other health agencies (like the United Kingdom’s NHS) and allowing pregnant people to make their own vaccination decisions, the FDA is allowing pregnant people to conduct a real-world risk-benefit analysis – one that takes into consideration their individualized risk and does not rely on the immunity status of others as a form of protection. And this risk-benefit analysis is truly individualized. Surely, a pregnant healthcare worker experiences a higher absolute risk than me, who spends her workdays typing on a laptop alone in an apartment – with all interactions with the outside world being entirely optional.
Similarly, the absolute risk may be higher depending on a person’s living situation. A pregnant person residing in a multigenerational home may not have the luxury of thinking exclusively about the risks to a developing fetus. Rather, they may have to balance those concerns against the risks of spreading the virus to older or vulnerable relatives. Whereas with other vaccines the FDA could conduct a risk-benefit analysis on a global level, with the COVID vaccine each person’s risk is highly individualized and affected by factors ranging from employment situation to living arrangement to (unfortunately) race and socioeconomic status.
And this is where the FDA succeeded in their decision to allow pregnant people to choose to get vaccinated. Unlike other routine vaccines, the COVID vaccine isn’t aimed at preventing an outbreak. Rather, it is a much-needed measure to halt a raging pandemic. With other illnesses (such as the chicken pox), it may be ethical to withhold vaccination during pregnancy as the pregnant person can rely upon herd immunity as a form of protection. Yet with COVID, withholding vaccines will undoubtedly lead to pregnant people becoming infected, and we know that pregnant people with COVID are at higher risk of severe illness than their non-pregnant counterparts.
By granting pregnant people the right to make this decision for themselves, the FDA has taken steps to protect autonomy and acknowledge that risk-perception and the associated risk-benefit analysis isn’t one size fits all. As with much of bioethics (and much of parenting for that matter) there is no objectively right decision – only the decision that an individual feels comfortable with. And by allowing pregnant people the right to choose, the FDA is truly enabling each pregnant person to act in their own best interest according to their specific situation.