NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) today announced topline results from a longer-term analysis of the safety and efficacy of their COVID-19 vaccine in individuals 12 through 15 years of age. The updated findings from the companies’ pivotal Phase 3 trial show that a two-dose series of the Pfizer-BioNTech COVID-19 Vaccine (30-µg per dose) was 100% effective against COVID-19, measured seven days through over four months after the second dose.
The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no serious safety concerns observed in individuals with at least 6 months of safety follow-up after the second dose.
“As the global health community works to increase the number of vaccinated people around the world, these additional data provide further confidence in our vaccine’s safety and effectiveness profile in adolescents. This is especially important as we see rates of COVID-19 climbing in this age group in some regions, while vaccine uptake has slowed,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We look forward to sharing these data with the FDA and other regulators.”
“These are the first and only disclosed longer-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals 12 through 15 years of age,” said Ugur Sahin, CEO and Co-founder of BioNTech. “The growing body of data we have compiled from clinical trials...
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