School children in protective medical masks walk along the street of a summer city

Bioethics Forum Essay

The FDA and the Moral Distinction Between Killing and Letting Die

In a recent New York Times column, Michelle Goldberg expresses frustration at the Food and Drug Administration’s failure to quickly authorize Covid vaccines for children under 12. The FDA has asked Pfizer-BioNTech and Moderna for four-to-six months of follow-up safety data in the children’s trials, although it required only two months of follow-up data in the adult trials. What justifies the extra time?

Ninety-five percent of the experts in the field are convinced that the vaccines are absolutely safe for children, says Yvonne Maldonado, a professor of pediatric infectious diseases at Stanford University and a lead investigator in Pfizer-BioNTech’s pediatric vaccine trial there, in Goldberg’s column. Ashish Jha, dean of Brown University’s School of Public Health, tells Goldberg that there is no evidence of any adverse side effects showing up in children after two months for other vaccines. Meanwhile, unvaccinated children are at greater risk of Covid because the Delta variant is much more transmissible than other variants. Why, then, is the FDA dragging its feet? The problem, Goldberg says, is that the FDA will not be blamed for avoidable Covid cases, but it would be blamed for unexpected vaccine side effects.

This asymmetry in blameworthiness, or responsibility generally, is sometimes referred to as the active-passive distinction. One of its instances is the distinction between killing and letting die. According to traditional medical ethics, doctors may never kill their patients, but it is permissible for them to withhold lifesaving treatment, under certain conditions, allowing their patients to die. This dictum is no longer universally accepted, as an increasing number of jurisdictions have legalized physician aid in dying. Nevertheless, many still adhere to the belief that there is an important moral distinction between actively killing and (merely) letting die.

A few philosophers have argued that the killing-letting die distinction has no moral importance. We have a strong moral duty to prevent deaths, just as we have a strong moral not to kill. (See Peter Singer, “Famine, Affluence, and Morality.”) However, acknowledging that we have a serious moral obligation to prevent avoidable deaths does not imply that this duty is as strong as the duty not to kill. Someone who buys a birthday present for her child, when she could have given the money to Oxfam, does not commit the moral equivalent of murder.

The responsibility of an organization, like FDA, is quite different from the responsibility of individuals. The job of the FDA is to protect the public’s health. To carry out this function, especially during a pandemic, the FDA has to consider both the risks of approving vaccines, such as unexpected side effects, and the risks of not approving vaccines, such as  avoidable deaths.  Requiring more data than is necessary to achieve safety will result in increased numbers of avoidable deaths. That’s on the FDA The fact that it would be failing to prevent deaths, as opposed to causing deaths, is irrelevant as regards its moral responsibility.  

So, is the FDA simply philosophically confused? Perhaps, but it seems more likely that there are other factors at work. Dr. Maldonado says that she suspects that the FDA wanted to allay the fears of people worried about the effects of the existing vaccines on kids by requiring more months of follow-up data. If she’s right, this was a misjudgment on the part of the FDA, and it might have the opposite effect. Just as giving the Pfizer, Moderna, and Johnson & Johnson vaccines “emergency use authorization” sparked fear among the vaccine-hesitant that  vaccines authorized only for emergency use weren’t really safe, so the request for more months of follow-up data from the pediatric trials might make those already worried about vaccine safety more concerned than the vaccines are not safe for children.

Another disturbing explanation for the slowness of the FDA is that it was afraid of being criticized by the noisy antivaccine movement. Fear of criticism should not play a role in medical decision making. Sadly, the FDA seems vulnerable to this kind of pressure, both from patient advocacy groups and Big Pharma; see the recent flap over its accelerated approval of aducanumab, the drug for Alzheimer’s disease, despite the overwhelming rejection by the independent committee advising the FDA.

If we are to get a handle on the Covid pandemic, children need to be vaccinated. Perhaps the solution is, as Goldberg suggests, for parents who want their kids vaccinated to yell and scream, to be the squeaky wheels that get the FDA’s attention. Personally, I would rather see a real reform in the FDA so that science and concern for the public’s health, not politics, drives its decisions.

Bonnie Steinbock, PhD, a Hastings Center fellow, is a professor emerita of philosophy at the University at Albany, State University of New York.

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  1. Thank you Professor Steinbock.

    Roughly put, the confidence that the risks of a course of action are acceptable, is appropriately in a balance with our confidence that the risks of not taking that course of action are unacceptable. We already have sufficient results—in hospital, in pediatric ICU’s—demonstrating the peril to children of our not vaccinating them, which exceed any existing evidence for concern administering this vaccine to younger children.

    Clinical studies are now ended when the results become sufficiently clear that an intervention is harming the people receiving it, or that the control group is being harmed by being denied it. The FDA needs to stop its “trial” now, because continuing it is unethical. Kids are going back in the first school year of Delta. They need the vaccine.

  2. Excellent post. I have two questions. First, because children cannot decide for themselves whether or not to take a treatment, such as vaccination, with uncertain risks, dose the FDA have more responsibility to assure safety of vaccines before approving them for children than it would for adults? Second, does the FDA need to factor into its decision-making the possibility that unanticipated toxicity of the Covid vaccine among children might discredit other vaccines and fuel pre-existing anti-vax sentiment and indirectly harm public health? Would these considerations argue for a higher degree of caution in approving vaccines for children? Thank you.

    1. As regards your first question about whether the FDA has a greater responsibility to assure vaccine safety for children, I think we should look at other vaccines. Whether it was the polio vaccine back in the 50s, or the more recent vaccines against measles, chicken pox, mumps, etc., it is the responsibility of the FDA to do what is reasonable to ensure that vaccines are safe and effective. Precisely the same is true of the Covid vaccine. The fact that children cannot consent does not pose a greater responsibility on the FDA. Moreover, vaccination needed to get a pandemic under control is especially important. As Dr. Gabriel notes, enabling children to return to school safely is paramount. As regards your second question about fueling anti-vax sentiment, the responsibility of the FDA is to do what is reasonable to avoid harmful side-effects. The two-month period required in the adult trials is sufficient. Without any evidence that harmful side effects in children show up after two months, there is no justification for requiring an additional two months for children, not when the costs of not vaccinating are so high.

  3. Public Health and Public Safety should be independent of Political oversight, as is the Federal Reserve.

  4. Thank you Dr.Steinbock for bringing to light such a prevalent topic that so little have yet to speak on.
    I agree most with your ending statement as such that the best solution here is to see real reform in the FDA so that we can begin to see more science leading decisions rather than politics.
    However, to play devil’s advocate, I must say I also agree with the FDA in withholding their judgement on the vaccine for children, not so much for the moral distinction between killing and letting someone die, but rather to prevent the past from happening again. In prior years, the FDA has been to blame for a handful of drugs going wrong following their approval, and although we have seemingly, as a society, moved on from this fact, it may be unforgivable if such mistakes were to be made on children rather than adults. Even if this may lead to more vaccine hesitancy, it may in the long run reverse such hesitancy following a longer approval process and such facts of safety and efficacy, especially on parents getting their children vaccinated.
    Such challenging pandemic times raise the ethical question as to which we need to value more, risking lives in the short term by extending research on the vaccines, or potentially risking lives in the long run by approving the vaccine too quickly. And thankfully such evolving science has made this question easier in recent months by knowing the vaccine is safe and effective, unfortunately it won’t always be so easy to answer in the future.

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