FDA approves Pfizer-BioNTech’s COVID-19 vaccine for children 12 to 15 years old
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The FDA has granted approval to Pfizer-BioNTech’s COVID-19 vaccine Comirnaty for use in adolescents aged 12 to 15 years, according to a company press release.
According to the release, Comirnaty is the only COVID-19 vaccine to be granted FDA approval for adolescents aged 12 years and older, following its emergency use authorization in May 2021.
According to the company, the approval is based on data from a phase 3 clinical trial of 2,260 participants aged 12 to 15 years, in which a two-dose series of the vaccine demonstrated an immune response in a subset of participants that was comparable to that seen in older teens and young adults.
The announcement comes after Comirnaty was previously approved for individuals aged 16 years and older in August 2021.
Pfizer and BioNTech have also submitted a supplemental biologics license application to the FDA to extend the approval of COMIRNATY to include booster doses for individuals aged 16 years and older, according to the release.
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