Pfizer and its partner BioNTech on Friday asked the Food and Drug Administration to greenlight its coronavirus vaccine for use in children 12 to 15 years old, just one week after the companies said a late-stage trial showed the vaccine was highly effective in this age group.
If U.S. regulators clear the request, it would make Pfizer’s shot the first to become available to younger teens. The move could also speed the timeline for getting more students back into school and curb costly safety measures being considered by education systems.
Of the three vaccines already in use in the United States, Pfizer’s shot is the only one now authorized for 16- and 17-year-olds.
Pfizer and BioNTech said they plan to submit similar requests to regulators in other countries in the coming days.
The companies’ FDA filing is based on data from a phase 3 trial of 2,260 kids ages 12 to 15 that they said shows the two-dose vaccine is 100 percent effective in this age group. The companies have said they plan to submit the results for publishing in a peer-reviewed journal.
Another trial studying the shot in children as young as 6 months old is also underway.
It’s not clear how long FDA might take to review Pfizer-BioNTech’s new request. The agency did not immediately respond to request for comment.
Moderna, which has developed a similar vaccine using mRNA technology, is also studying its use in teens and young children, but it is unclear when the company will file for emergency use.
Pfizer-BioNTech and Moderna have promised 300 million doses apiece to the U.S. government, accounting for most of the shots that could help President Joe Biden reach his goal of having enough vaccines for all eligible Americans by this summer.