Little cute child with mask getting injection

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

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  1. First of all, understood as providing your child with a benefit that another child will not get (if you have made the judgment—very reasonable given all the prior experience with vaccines with adults and age-adjacent children—that the vaccine has fewer risks than being without the vaccine), parents are allowed to be biased in taking care of their child before other children, when the stake is the same. We’re not talking about your child having a Latin tutor before another child gets one hot meal each day. What you’re getting for your child in the study might be getting a sub-efficacious dose when no one can choose to get an efficacious dose, or an efficacious dose before some other child does.

    It appears your child would be a safer subject for the study, and a more informative one, because given your very deliberative decision-making, you will credibly be an extremely vigilant observer. Better data, safer for a child closely observed, and more likely to appear for the second dose without fail.

    Given the sad apparent rate of vaccine hesitancy, it does not seem that at the point a study would confirm the efficacy and safety of a vaccine in your child’s age group, that other children will be denied immediate access because of vaccine supply. We’re going to be oversupplied. The more efficiently we can complete said study, the faster all the children of that age group whose parents accept the vaccine will be able to proceed with being vaccinated. There is also something to be said about the value of teaching children of the expectation that we all try to contribute to the good of each other—and your four year old’s participation would be something you could certainly tell them of, when something later occasioned a teaching moment that they could understand. “You’ve already played a part in helping your community.”

    If your family’s risk profile and needs are better than those of another family, it is increasingly likely that this would only be because a rare inability to receive the vaccine, rather than access problems for other members of the family—as how wouldn’t that also be true for their child(?)—or else the vulnerable part of the other family’s choice. Such an vaccine hesitant vulnerable individual would make be less likely to throw their influence in to having “their” child vaccinated in a study. So if this is a live-in anti-vax grandfather, and the child’s parents would like to protect the grandfather as well as their child, I’m still not persuaded that you need to take risks with your child to protect adults who will not do what they can to protect themselves.

  2. @Dan Gabriels MD – thanks for your thoughtful comments. I agree with you that the faster trials can enroll and collect data, the sooner vaccines can be rolled out for additional age groups to the benefit of all. Choosing to be part of a clinical trial – but also choosing to be vaccinated when eligible, and adhering to appropriate COVID precautions during the pandemic – contributes to the greater good and can afford valuable learning opportunities for kids to understand how they are interconnected with their community and society.

    To further clarify my remarks in response to one point you made: I believe there are risks some families might have that mine does not that are not related to choices or inabilities to be vaccinated. My own household is not currently reliant on school or childcare outside our home, for example. But families who do rely on childcare and school outside the house might want to reduce their child’s risks of acquiring COVID in those settings. Especially, as you say, given variable uptake of vaccines that may mean some kids continue to be exposed to unvaccinated adults outside their households in those environments.

    Notably just after this essay posted Pfizer announced it is seeking emergency use authorization for ages 2-11 in September- much sooner than previously anticipated.

    1. Thank you for identifying a circumstance which I had not accounted, having to exposure your child to other people—other children who can’t yet have been vaccinated, and perhaps adults who could have been but have chosen not to be vaccinated. Not everyone has a lot of choice about who they receive unavoidable childcare from.

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