- A panel of advisers to the Centers for Disease Control and Prevention will meet Wednesday to consider whether to recommend use of Pfizer and BioNTech’s coronavirus vaccine in young teenagers
- The committee, made up of 15 infectious disease doctors and pediatricians, is expected to support the FDA’s authorization of the shot in 12- to 15-year-olds, which the agency granted Monday. While some states have already begun to offer vaccination to adolescents in that age range, others are waiting for the CDC panel’s endorsement.
- The experts will discuss the safety and efficacy of the vaccine in adolescents, as well as distribution and administration considerations. A vote is scheduled for mid-afternoon Wednesday.
The FDA’s decision Monday to expand the authorization of Pfizer and BioNTech’s vaccine was a significant step, making millions of younger adolescents in the U.S. eligible to receive the shot ahead of summer camps and the next school year.
While children and teens are at much lower risk of severe illness of death, they are still susceptible to infection and can experience more serious symptoms, particularly for those individuals who have other medical conditions.
In authorizing the vaccine for use in young teens, the FDA highlighted clinical data that showed the shot to be similarly safe and effective as in young adults. But as Pfizer and BioNtech’s study mostly enrolled adults over 18, the supporting results come from only a couple thousand participants aged 12 to 15.
Wednesday’s meeting will offer a forum for a more thorough public vetting of that data, which could help build confidence in the FDA’s decision. Because the risk of COVID-19 to adolescents is lower, the experts’ assessment could focus on side effects in particular. Trial data showed reactions to vaccination in 12- to 15-year olds were similar to what was observed in those older than 16, the FDA said Monday. Injection site pain, headache, tiredness and fever were most common and typically mild or moderate in degree.
The regulator plans to hold an advisory committee meeting of its own in June to discuss the data it would need to evaluate vaccine use in children younger than 12.
Through Tuesday, about 153 million people older than 16 had received at least one dose of a coronavirus vaccine, CDC data show, equivalent to about 46% of the U.S. population. There are roughly 17 million adolescents aged 12 to 15 in the U.S., according to numbers cited by the Kaiser Family Foundation.