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Pfizer and BioNT ech Request Regulatory Agencies Expand Emergency Use of Their COVID-19 Vaccine to Adolescents - 12 to 15 years of age

Mary Wilson

Well-known member
NEW YORK and MAINZ, GERMANY, April 9, 2021 ? Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today requested amendments to the U.S. Emergency Use Authorization (EUA) of the Pfizer-BioNTech Vaccine (BNT162b2) to expand the use in adolescents 12 to 15 years of age. The companies plan to request similar rulings by other regulatory authorities worldwide in coming days. ...

... Topline results from an efficacy analysis on 12 to 15 year old participants through cases accured by March 31, 2021 from the Phase 3 trial were recently announced. In this analysis, BNT162b2 was well tolerated with side effects generally consistent with those observed in participants 16 to 25 years of age. 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. ...

https://cdn.pfizer.com/pfizercom/20...df?VersionId=Vg2h9d1M1XTo58jO8UIogPxXeLcn27cH
 
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