The companies’ FDA filing is based on data from a Phase 3 study of 2,260 children ages 12-15 that found the two-dose vaccine to be 100 percent effective in that age group. The companies have announced that they will submit the results for publication in a peer-reviewed journal.
Another attempt to study the shot in children 6 months old is also underway.
It’s not clear how long it might take the FDA to consider Pfizer-BioNTech’s new request. The agency did not immediately respond to the request for comment.
Moderna, which has developed a similar vaccine using mRNA technology, is also investigating its use in teenagers and young children. However, it is unclear when the company will file an emergency application.
Pfizer-BioNTech and Moderna have promised the US government 300 million doses apiece, which is the bulk of the shots that could help President Joe Biden achieve his goal of getting enough vaccines for all eligible Americans by the summer to have.