Bioethics Forum Essay
Should We Enroll Our Child in a Covid-19 Vaccine Trial?
My partner and I are thinking a lot about this question. Moderna and Pfizer trials are running in our community–at the children’s hospital where I work as a clinical ethicist. The Pfizer trial began enrollment of 5-to-11-year-olds. My almost 4-year-old kid would be in the next cohort.
As a clinical ethicist I am engaged in weighing risks and benefits of medical decisions. Yet when it comes to doing this for my child and family, it’s complicated. Risks and benefits of Covid-19 vaccine trials are multifaced, sometimes uncertain, and difficult to quantify.
Let’s start with what is clear. In my family, the benefits of Covid-19 vaccination far outweigh the known risks. My spouse and I were vaccinated when eligible.
Less clear are the risks that Covid-19 poses to children, and that children pose to their communities. Children comprise less than 12% of confirmed Covid infections (only 2% of cases are children 4 years old and under), and kids are less likely to become seriously ill from the virus. But findings also suggest that kids can develop Multisystem Inflammatory Syndrome in Children (MIS-C) requiring hospitalization, weeks after a Covid infection of which they may have had only mild or no observed symptoms. Experts reach different conclusions about what these data mean for public policy regarding children, and how they should guide individual practices.
Also unclear are the longer-term impacts of the virus and the vaccines. But based on the minimal known or anticipated risks of vaccines versus the known risks of Covid-19 infection –risks vaccines have been shown to mitigate–we want our child to be vaccinated against Covid when it is safe and feasible to do so.
Would a clinical trial be safe enough?
Clinical trials only expand to include younger ages once they have demonstrated safety and efficacy in older groups. Adult trials of the Moderna and Pfizer vaccines demonstrated high efficacy rates with minimal side effects. The millions of doses administered outside of trials seem to substantiate these findings. Pfizer’s data on 12-to-15-year-olds show even better efficacy than in adults. My child would be in one of the youngest study cohorts, and, therefore, safety and efficacy would have already been shown in young children before we would face the choice of whether to consent to enrollment.
Evidence of safety from a clinical trial doesn’t guarantee safety, of course. Any intervention has risks. The AstraZeneca and Johnson & Johnson vaccines illustrate that some adverse events are so rare they do not occur during the clinical trials. Those risks persist even after vaccine authorization–and possibly after formal vaccine approval–and yet we don’t plan on delaying our child’s vaccination once a pediatric formulation is authorized.
One risk of participating in a vaccine trial might be not receiving a dose of vaccine. The Moderna KidCOVE Study is enrolling children ages 6 months to 11 years to receive either a placebo or the study vaccine. Pfizer trials in children under 12 are not using placebos, but are instead administering different doses of the vaccine to all participants and studying optimal doses and acquired antibodies. My child could end up under-vaccinated or unvaccinated for the duration of a study, even if a different vaccine receives approval for use in under 5-year-olds while enrolled in a clinical trial.
Yet the overwhelming sense I have–right or wrong–is that a clinical trial is an early access ticket to a safe and effective vaccine for my kid. Perhaps this is a therapeutic misconception. But given findings in adults and older children, and recent practices to fully vaccinate those who received placebos once vaccines are authorized, I see a clinical trial as a way to get our child a vaccine well before the anticipated timelines for rollout among younger kids. And this comes with different kinds of risks.
I already have concerns about equitable vaccine access. If clinical trial participation is a route to early vaccine access, there is reason to worry not only about fairly distributing the burdens of research, but also its potential benefits. Given my own family’s risk profile and needs, there are reasons not to enroll my kid in a clinical trial when other families could derive more benefit from their child’s faster access to vaccination.
After submitting an interest form on the Pfizer vaccine trial website recently, I received a message that I would be contacted if space opens up in the trial site in my area. And if a spot becomes available? In this case, my job as a parent helps me better understand my job as an ethicist: sometimes people don’t know what they would choose until they are faced with the situation of having to decide.
Elizabeth Lanphier, PhD, MS, is an assistant professor in the Ethics Center at Cincinnati Children’s Hospital Medical Center and in the Division of General and Community Pediatrics in the Department of Pediatrics at the University of Cincinnati College of Medicine. @EthicsElizabeth