(RTTNews) – The U.S. Food and Drug Administration has fully approved the COVID-19 vaccine from Pfizer Inc. (PFE) and BioNTech SE (BNTX) for adolescents ages 12 to 15, the companies announced Friday in a statement. communicated.
The vaccine, known as Comirnaty, was previously made available to the age group in the United States under emergency use authorization, and to date more than 9 million adolescents 12 to 15 year olds in the United States have completed a primary series.
The vaccine is the first and only COVID-19 vaccine to gain FDA approval for adolescents 12 and older, following emergency use authorization in May 2021.
The approval was based on data from a phase 3 clinical trial of 2,260 participants aged 12 to 15. A two-dose primary series of the vaccine (30 microgram dose) elicited geometric mean SARS-CoV-2 neutralizing antibody titers of 1,239.5, demonstrating strong immunogenicity in a subset of one-month-old adolescents. after the second dose.
Pfizer and BioNTech have also filed the data with the European Medicines Agency and other regulatory authorities around the world.
Comirnaty was previously approved by the FDA for persons 16 years of age and older in August 2021. Pfizer and BioNTech have also submitted a Supplemental Biologics License Application to the US FDA to extend Comirnaty’s approval to include doses booster for people aged 16 and over, which are currently cleared by the European Medicines Agency.
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