FDA Authorizes Pfizer Vaccine for Use in Adolescents 12 to 15

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The Food and Drug Administration on Monday authorized the first Covid-19 vaccine for use in adolescents.

The move puts medical personnel on track to begin distributing a vaccine developed by Pfizer/BioNTech to individuals aged 12 to 15. The companies had submitted an amended application for approval after a clinical trial completed in March found the vaccine was 100 percent approval for patients in the age group, better than its roughly 95 percent efficacy rate among adults.

The trial included 2,260 test subjects. Eighteen participants in a placebo group reported contracting Covid-19 compared to none of those in the group who received the vaccine. The agency is still conducting tests on those aged 11 and younger.

A Centers for Disease Control and Prevention advisory committee will meet Wednesday to conduct a final vote on the matter. Distribution of the vaccine to adolescents could begin as early as this week if the CDC provides a final green light.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” acting FDA Commissioner Janet Woodcock said in a Monday statement. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

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