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COVID-19 Resource Center

April 09, 2021
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Pfizer, BioNTech formally ask FDA to make vaccine available to adolescents

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Pfizer and BioNTech said Friday that they have formally asked the FDA to make their COVID-19 vaccine available to adolescents aged 12 to 15 years through an emergency use authorization.

On Twitter, the companies said their hope is that the vaccine will be available for this age group by the start of next school year.

Source: Adobe Stock
Pfizer and BioNTech have asked the FDA to authorize their COVID-19 vaccine for use in children aged 12 to 15 years.
Source: Adobe Stock

“We plan to request similar rulings by other regulatory authorities worldwide in coming days,” the companies tweeted.

The request was anticipated. The companies announced last month that the vaccine was highly protective among children aged 12 to 15 years enrolled in a phase 3 trial and said they would be seeking emergency use authorization in this age group.

Experts at the time called the results “extremely exciting,” if expected, and said the emergency use authorization could bring the country closer to being fully vaccinated.

The vaccine is already authorized for emergency use in the United States for people aged 16 years or older — the only COVID-19 vaccine so far that is available to children of any age.