Why FDA Should Not Authorize COVID Vaccines for Kids, Teens

The authors (two physicians and a professor) argue that Emergency Use Authorization for mass child vaccination presents a different balance of risks and benefits than it did for adults.

The rapid development of highly effective COVID-19 vaccines is a triumph of science and, with equitable implementation strategies, represents humanity’s path out of the COVID-19 pandemic. To expedite deployment in the U.S., three COVID-19 vaccines were provided Emergency Use Authorization (EUA) while concurrently undertaking the traditional review process.

Pfizer has requested the FDA amend the existing EUA for its vaccine to allow eligibility for children aged 12 to 15, and further clinical trials of COVID-19 vaccines, including for younger children, are underway. Unlike for adults, however, the likelihood of severe outcomes or death associated with COVID-19 infection is very low for children, undermining the appropriateness of an EUA for child COVID-19 vaccines.