Pfizer-BioNTech COVID-19 vaccine 100% efficacious in adolescents, finds trial
USA: BNT162b2 vaccine has demonstrated 100% efficacy and robust antibody responses in adolescents aged 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, according to results from a pivotal Phase 3 trial in 2,260 adolescents.
The Pfizer-BioNTech COVID-19 vaccine BNT162b2 is already in use among adults. The efficacy shown by the vaccine in adolescents has exceeded the earlier records in vaccinated participants aged 16 to 25 years old.
"We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year."
"Across the globe, we are longing for a normal life. This is especially true for our children. 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.
The trial enrolled 2,260 adolescents 12 to 15 years of age in the United States.
Key findings of the study include:
- 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 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.
- BNT162b2 administration was well tolerated, with side effects generally consistent with those observed in participants 16 to 25 years of age.
The BNT162b2 vaccine is available under emergency use authorization for people aged 16 and older. The companies say they will file an amendment with U.S. and European drug agencies, seeking authorization for use in the younger group.
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