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Archive for May 11th, 2021

FDA Expands EUA for Pfizer-BioNTech COVID-19 Vaccine to Include 12-15-Year-Olds

FDA logoThe U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12-15 years of age.  From 3/1/2020 through 4/30/2021, approximately 1.5 million COVID-19 cases in individuals 11-17 years of age have been reported to the U.S. Centers for Disease Control.  Based on immunogenicity and an analysis of COVID-19 cases, the FDA has determined the Vaccine’s known and potential benefits outweigh the known and potential risks, supporting the Vaccine’s use in this population.  As part of the original EUA request, Pfizer Inc. submitted a plan to continue monitoring the Vaccine’s safety, and this plan has been updated to include the newly authorized adolescent population.  Updated Fact Sheets are also now available for Healthcare Providers Administering the Vaccine and for Recipients and Caregivers.  For more information, see the FDA Coronavirus Disease 2019 page.