On Wednesday, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices recommended that the CDC approve the use of the Pfizer/BioNTech COVID-19 vaccine for the 12- to 15-year age group. The decision comes two days after the Food and Drug Administration granted an emergency use authorization for the same age group and will help the US further limit the pool of people who can spread infections or foster the evolution of new viral variants. Given recent history, formal CDC approval could come quickly.
Because of the FDA’s earlier decision, the move might seem anticlimactic. But having the FDA and CDC officially on the same page is reassuring, and several state-run vaccination programs are awaiting the CDC’s OK before expanding into the age group. Private providers and insurance companies were also varied in their response to the FDA’s decision and were waiting for the CDC.
The data supporting the approval was pretty decisive, as a small Phase III clinical trial of 2,260 adolescents saw 16 cases of COVID-19, with each one occurring in the placebo group. Side effects were similar to those experienced by older people, with participants experiencing a brief period of flu-like symptoms. The committee was tasked with considering whether the benefits outweighed the risks; because of the minor side effects and the increasingly obvious benefits of vaccination, it’s no surprise that the vote in favor of approval by the committee showed 14 in favor, none opposing, and a single recusal. CDC Director Rochelle Walensky is very likely to follow the committee’s recommendation, most likely before the day is over. (We’ll update this story if and when the CDC acts.)