- MedPage Today - May 10, 2021 - Molly Walker -
The Pfizer/BioNTech COVID-19 vaccine was authorized for use in adolescents as young as 12, the first COVID-19 vaccine in the U.S. to receive emergency use authorization (EUA) in this younger age group, the FDA announced on Tuesday.
The agency amended the existing EUA to include teens ages 12 to 15 after the vaccine demonstrated 100% efficacy against symptomatic disease in this age group in a randomized trial. Pfizer's vaccine was first authorized in December 2020 for people 16 and older.
"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," said Acting FDA Commissioner Janet Woodcock, MD, in a 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."
In the 2,260-person phase III trial, 16 cases of COVID-19 were observed in the placebo group versus none in the vaccine group.
Teens in the trial were randomized 1:1 to the vaccine or placebo. Lab results in a subset of participants showed that the vaccine generated a strong immunogenic response 1 month following the second dose, which was non-inferior to SARS-CoV-2 neutralizing antibody geometric mean titers generated by people ages 16-25 in earlier studies with the vaccine.
The vaccine was generally well tolerated, and side effects were consistent with the older age group. The most common side effects were pain at the injection site, tiredness, headache, chills, and joint pain, which lasted 1 to 3 days following vaccination.
Presumably, more detailed data will be presented on Wednesday's scheduled emergency meeting of the CDC's Advisory Committee on Immunization Practices (ACIP), which will review the data and vote on adding the vaccine to the recommended child and adolescent immunization schedule in this age group.
In addition, the companies continue to study two doses of the vaccine in three age groups of healthy children: ages 6-11, ages 2-5 and ages 6 months to 2 years.
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