Pfizer and its partner BioNTech on Friday asked the Food and Drug Administration to release the coronavirus vaccine for children aged 12 to 15, just one week after the companies said a late-stage study showed that the vaccine was very effective in this age group. .
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Of the three vaccines already in use in the United States, Pfizer’s shot is the only one now allowed for 16- and 17-year-olds.
If U.S. regulators approve the request, Pfizer’s lap will be the first to be available to younger teens. The move could also accelerate the timeline for returning more students and combating costly safety measures being considered by education systems.
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Of the three vaccines already in use in the United States, Pfizer’s shot is the only one now allowed for 16- and 17-year-olds.
Pfizer and BioNTech have said they plan to make similar requests to regulators in other countries in the coming days.
The FDA submission of the companies is based on data from a phase 3 trial of 2,260 children aged 12 to 15 years, which they say shows that the two-dose vaccine is 100 percent effective in this age group. The companies said they plan to submit the results for publication in a peer-reviewed journal.
Another trial of the shot of children as long as 6 months is also underway.
It is not clear how long the FDA may take to review the new request from Pfizer-BioNTech. The agency did not immediately respond to a request for comment.
Moderna, which is developing a similar vaccine using mRNA technology, is also studying its use in teens and young children, but it is unclear when the company will need to file an emergency file.
Pfizer-BioNTech and Moderna have pledged 300 million doses apiece to the U.S. government, making up the most shots that could help President Joe Biden achieve his goal of having enough vaccinations for all Americans by this summer.
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