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FDA Authorizes Pfizer-BioNTech Vaccine for Emergency Use in Adolescents

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eMediNexus    11 May 2021

The U.S. Food and Drug Administration has expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to now include adolescents 12 to 15 years of age. 

The EUA originally issued on December 11, 2020 for administration of the vaccine in individuals 16 years of age and older has been amended by the agency. The FDA ascertained that the vaccine developed by Pfizer and BioNTech met the criteria for amendment of the EUA, and the known and potential benefits of the vaccine in people 12 years of age and above outweigh the known and potential risks, thus supporting the use of the vaccine in this population group… (FDA, May 10, 2021)

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