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The Pfizer-BioNTech COVID-19 vaccine demonstrated 100% efficacy against symptomatic disease in adolescents as young as age 12, .

In the 2,260-person trial, 18 cases of COVID-19 were observed in the placebo group versus none in the vaccine group, according to topline results from the phase III trial in adolescents ages 12-15.

The companies said they plan to submit these data to the FDA as a proposed amendment to the vaccine's emergency use authorization in the coming weeks. Their COVID-19 vaccine is currently authorized for use among ages 16 and older.

In the companies' announcement, Pfizer Chairman and CEO Albert Bourla noted the hope of starting to vaccinate younger adolescents "before the start of the next school year."

BioNTech CEO and co-founder Ugur Sahin also suggested that a vaccine for this age group was a path back to in-person learning, stressing the importance of enabling these students "to get back to everyday school life and to meet friends and family while protecting them and their loved ones."

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. Pfizer and BioNTech said they would submit the results to a peer-reviewed journal for publication.

The companies also teased a phase I/II/III study of children ages 6 months to 11 years. The company is testing the 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. The first vaccines were administered last week.

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