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Pfizer Says its COVID-19 Vaccine Is 100 Percent Effective in Kids 12-15

November 24, 2021

The two-dose Pfizer-BioNTech COVID-19 vaccine regimen was 100 percent effective in preventing disease in children aged 12-15 years, the companies reported.

The numbers are from an updated analysis of phase 3 data in 2,228 subjects aged 12-15 years. From November 2020-September 2021, 30 cases of COVID-19 developed, all of which were in the placebo group, the companies said. The vaccine appeared safe as well, with no serious concerns identified in a 6-month safety analysis.

The companies plan to submit a supplemental Biologics License Application to the FDA to expand the vaccine’s approval to include children aged 12 years and older. As of right now, this population can receive the vaccine under FDA’s Emergency Use Authorization, which was granted in May.

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