Adolescents Benefit From Pfizer-BioNTech COVID-19 Vaccination
Germany-based BioNTech SE and Pfizer, Inc. announced that, in a Phase 3 trial in 2,260 adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 coronavirus infection, in the USA, the Pfizer-BioNTech COVID-19 vaccine BNT162b2 demonstrated 100% efficacy and robust antibody responses, was well tolerated, with side effects generally consistent with previous data.
These new study results exceed those recorded earlier in vaccinated participants aged 16 to 25 years old.
In this 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 BNT162b2 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. 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.
The companies stated they plan to submit these data to the U.S. FDA and the EMA for a requested amendment to the Emergency Use Authorization of BNT162b2 and the EU Conditional Marketing Authorization for COMIRNATY® to expand use in adolescents 12-15 years of age as quickly as possible.
“The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant. It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones,” said Ugur Sahin, CEO, and Co-founder of BioNTech, in a press statement.
The Pfizer-BioNTech COVID-19 Vaccine, BNT162b2, has not been approved or licensed by the U.S. FDA but has been authorized for emergency use by FDA under an Emergency Use Authorization to prevent COVID-19 for use in individuals 16 years of age and older.