FDA to authorize Pfizer's Covid-19 vaccine for 12-to-15-year-olds by early next week
The US Food and Drug Administration is poised to authorize Pfizer/BioNTech's coronavirus vaccine in children and teens ages 12 to 15 by early next week.
The FDA is currently reviewing data submitted by Pfizer to support the extended use. Pfizer said at the end of March that a clinical trial involving 2,260 12-to-15-year-olds showed its efficacy is 100% and it is well tolerated. The vaccine is currently authorized in the US for emergency use in people 16 and older.
With the consistently positive findings, the Pfizer-BioNTech shot may even be approved by the FDA for emergency use in even younger children by fall this year, the Associated Press reported.
Pfizer and Moderna both are testing their vaccines in children as young as 6 months and expect to ask the FDA for EUAs covering infants and children later this year.