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Pfizer, BioNTech Get Full FDA Approval for Covid Vaccine for Teens

Pfizer Inc. and BioNTech SE gained full US regulatory approval for their Covid-19 vaccine for teens 12 to 15 years old, a milestone that will allow the companies to continue to market it to adolescents after the pandemic. The vaccine partners earlier got formal approval for their Covid vaccine for teens 16 and older. In a statement on Friday, the companies said the US Food and Drug Administration approved their supplemental application to extend that approval to younger adolescents. The shot first went into play when it received emergency use authorization, a temporary clearance for use during the pandemic, for the age group. For full approval, the companies submitted additional information to the FDA, including six months of follow-up data after the two-dose regimen was complete in recipients.

Bloomberg - July 10, 2022

View the full story here: https://www.bloomberg.com/news/articles/2022-07-08/pfizer-biontech-get-fda-approval-for-covid-vaccine-for-teens