Pfizer and BioNTech requested regulatory agencies expand Emergency Use of COVID-19 vaccine to adolescents
On Apr. 9, 2021, Pfizer announced they had 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 planned to request similar rulings by other regulatory authorities worldwides. These requests are based on data from the pivotal Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, which demonstrated 100 percent efficacy and robust antibody response after vaccination with the COVID-19 Vaccine.
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Source: Pfizer
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