April 9, 2021 at 6:29 pm #100002584zpodiumKeymaster
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.
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