The Ethics of “Off-Label” Vaccinations for Kids




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The WSJ reports that some parents hope to get their kids (under 12) vaccinated against Covid, as “the FDA’s approval generally means vaccines are eligible for off-label use, meaning beyond approved populations.” However, “the FDA and Centers for Disease Control and Prevention have emphasized that the safest thing for this group of children is to wait for more data to be analyzed.”I’m curious whether it’s really true that waiting is “safest”, or whether these advisories ignore status quo risk. I don’t have the empirical knowledge to answer what really would be safest here, but questions worth asking include:(1) How many kids in this age group are expected to (i) suffer serious ill-effects, or (ii) die from Covid during this “wait”?(2) Given our background knowledge of similar vaccines, including the results of clinical trials for this vaccine on adolescents, what proportion of kids would you expect to (i) suffer serious ill-effects, or (ii) die if administered a “best guess” fractional dose of this vaccine?It would be pretty extraordinary if the vaccine posed a greater risk of death than Covid. But if it doesn’t, that would surely go some way towards undermining the assumption that waiting is necessarily “safer”: it increases your child’s risk of death! Perhaps the risk of non-lethal but still serious vaccine side-effects could be great enough to outweigh the (typically mild) risks from Covid for this age group? Maybe… The comparative risk is something I’d really want to hear explicitly addressed by medical experts before trusting the FDA/CDC advice, given how ethically incompetent these agencies are.Put another way: it could be worth asking your pediatrician: “Given all that we currently do and don’t know about the possible risks of each, would it likely be overall safer for my kid to get the Covid vaccine off-label or to get infected with the Delta variant while unvaccinated and waiting for more data?”I would be amazed if. . .

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