- A panel of advisers to the Centers for Disease Control and Prevention endorsed use of Pfizer and BioNTech's coronavirus vaccine in young teenagers, adding their support on Wednesday to the Food and Drug Administration's authorization of the shot for 12- to 15-year-olds earlier this week.
- The committee, made up of infectious disease doctors and pediatricians, voted 14-0 to recommend the shot for adolescents. One panelist recused herself because she was involved in coronavirus vaccine clinical trials.
- The vote, which the CDC officially adopted hours after, gives a clear green light for states to begin vaccinating 12- to 15-year-olds. While some had already begun to offer vaccinations to adolescents in that age range, others were waiting for the CDC's panel endorsement.
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.
"This is a really important issue for this summer," said Camille Kotton, an infectious disease doctor at Massachusetts General Hospital and a panelist, referring to vaccinating young teens. "This is another way to get closer to ending this horrible pandemic."
Committee members agreed the benefits far outweighed the risks and noted more data would be collected following the shot's roll-out in adolescents.
"I want to remind everyone that intensive safety scrutiny of this vaccine will continue after the authorization," said Matthew Daley, a researcher at Kaiser Permanente Colorado and a panelist. "We're just going to get more data on the 12- to 15-year-olds."
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 offered a forum for a more thorough public vetting of that data, which could help build confidence in the FDA's decision. CDC officials, as well as a representative from Pfizer, detailed the trial results as well as epidemiological data on COVID-19 infections in younger adolescents to help the committee members make their decision.
In particular, the Pfizer representative compared rates of side effects in 12- to 15-year olds to those in older teenagers and young adults. Injection site pain, headache, tiredness and fever were most common and similar in rate between the two groups. Almost all were mild to moderate in degree.
During Wednesday's meeting, the CDC noted it would no longer advise against co-administering other vaccines alongside coronavirus shots, as it has since Pfizer's and Moderna's were first authorized in the U.S. The agency is cautioning, however, that providers consider the strength of reactions different vaccines elicit, as it's not known whether so-called "reactogenicity" increases with co-administration.
Looking ahead, the FDA 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.
Editor's note: This story has been updated to reflect the outcome of the committee's vote on Wednesday afternoon and to include the official adoption of the vote into CDC guidance.