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News > U.S.

Pfizer COVID-19 Vaccine Is 100% Effective in Kids Aged 12-15

  • A vial of Pfizer/BioNTech COVID-19 vaccine

    A vial of Pfizer/BioNTech COVID-19 vaccine | Photo: Xinhua

Published 1 April 2021
Opinion

The FDA authorized the Pfizer-BioNTech vaccine for emergency use in individuals 16 years of age and older in December last year.

The companies Pfizer and BioNTech announced their COVID-19 vaccine has demonstrated 100 percent efficacy and robust antibody responses in a Phase 3 trial in adolescents 12 to 15 years of age.

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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 versus none in the vaccinated group.

The vaccine, 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. The results exceeded those recorded earlier in vaccinated participants aged 16 to 25 years old.

"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," BionNTech CEO Ugur Sahin said.

"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."

The two companies plan to submit these data to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency as soon as possible to request expansion of the Emergency Use Authorization and EU Conditional Marketing Authorization for BNT162b2.

The FDA authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in the U.S. in December last year. The vaccine, the first that got FDA approval in the country, was authorized for use in individuals 16 years of age and older.

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