Pfizer-BioNTech announce positive topline results of pivotal COVID-19 vaccine study in adolescents

Pfizer Inc. and BioNTech SE announced that, in a Phase III trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, the Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old, and was well tolerated. These are topline results from a pivotal Phase III trial in 2,260 adolescents.

About the Phase III Data from Adolescents 12-15 Years of Age : The trial enrolled 2,260 adolescents 12 to 15 years of age in the United States. In the trial, 18 cases of COVID-19 were observed in the placebo group (n=1,129) versus none in the vaccinated group (n=1,131). Vaccination with BNT 162b2 elicited SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs) of 1,239.5, demonstrating strong immunogenicity in a subset of adolescents one month after the second dose. This compares well (was non-inferior) to GMTs elicited by participants aged 16 to 25 years old (705.1 GMTs) in an earlier analysis. Further, BNT 162b2 administration was well tolerated, with side effects generally consistent with those observed in participants 16 to 25 years of age.

The companies plan to submit these data to the FDA and EMA for a requested amendment to the Emergency Use Authorization of BNT 162b2 and the EU Conditional Marketing Authorization for Comirnaty to expand use in adolescents 12-15 years of age as quickly as possible. All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose. Pfizer and BioNTech plan to submit the data for scientific peer review for potential publication.