Pfizer Seeks Full U.S. Approval for Covid Shot in Kids 12 to 15
(Bloomberg) -- Pfizer Inc. and partner BioNTech SE asked U.S. regulators to grant full approval for their Covid-19 vaccine in children ages 12 to 15, a move that could open the door to vaccine mandates in schools next year.
The vaccine is currently approved in the U.S. for people 16 and older, and has emergency authorization for children from 5 to 15. Twelve-to-15 year-olds receive the full adult dose of the vaccine, while younger children get a smaller dose.
In a statement on Thursday, the companies said the request for approval included updated data from a final-stage trial including over 2,000 adolescents from 12 to 15. In the trial, two doses of the vaccine were shown to be 100% effective from seven days to more than four months after the second shot.
The companies said the safety profile was favorable through at least six months after the second dose.
To date, only about half of all U.S. adolescents are fully vaccinated. A full, formal FDA approval could help sway parents who are worried that the emergency clearance wasn’t sufficiently rigorous.
An approval could also give local officials cover to mandate vaccines in middle and high schools with less fear of legal or political pushback.
Vaccine mandates in school aren’t new. Schools routinely require students to get shots for measles, chickenpox, polio, and other well known diseases. All 50 states and the District of Columbia have immunization requirements for children to be able to attend school. Many public-health experts consider mandates one of the best forms of U.S. disease control.
In the statement, Pfizer and BioNTech said they intended to file the same data with regulators in Europe and other parts of the world in the coming weeks.
U.S. regulators granted emergency authorization for the vaccine in 12-to-15 year olds in May.
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