FDA authorizes Pfizer/BioNTech COVID-19 vaccine for teenagers
The EUA, issued in December, had originally covered individuals aged 16+.
The dosing for adolescents is the same as for all other ages: with two doses administered three weeks apart.
While children and adolescents generally have a milder diseases course than adults, around 1.5 million COVID-19 cases in adolescents aged 11-17 years old have been reported in the US over the last year.
At the end of March, Pfizer and BioNTech announced the topline results of its Phase study in adolescents. The trial covered 2,260 participants (1,131 of whom received the vaccine). Vaccination with BNT162b2 elicited SARS-CoV-2–neutralizing antibody geometric mean titers, which compared well to participants aged 16-25 years old. The vaccine was well tolerated, again with side effects generally consistent with 16-25 year olds.
Acting FDA Commissioner Janet Woodcock, M.D., said: “This [authorization] 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.
"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.”
While the Pfizer/BioNTech vaccine is available in 91 countries and territories around the world, the vast majority of participants in trials came from the 18+ age group; with authorizations shaped accordingly (the US, Europe and Canada, for example, had all authorized the vaccine for ages 16+).
Last week Health Canada expanded authorization for the vaccine in the country to teens aged 12-15 years old.
Meanwhile, Pfizer and BioNTech's Phase 1/2/3 study in children aged 6 months to 11 years old is ongoing.