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Pfizer's COVID-19 vaccine scores FDA nod in adolescents, enabling a wider rollout


In a first for the U.S., the FDA has authorized the use of Pfizer's BioNTech-partnered COVID-19 vaccine for use in adolescents between the ages of 12 and 15—months ahead of the upcoming school year in the fall. The FDA will amend the existing emergency authorization for the vaccine, which was first issued in December, the agency said. Pfizer’s vaccine is currently the only shot allowed in the U.S. for Americans as young as the age 16. The vaccine's two-dose regimen will be the same for adolescents as it is for adults, the agency said. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” Acting FDA Commissioner Janet Woodcock, M.D., said in a statement.

FiercePharma - May 10, 2021

View the full story here: https://www.fiercepharma.com/pharma/pfizer-s-covid-19-vaccine-scores-fda-nod-adolescents-enabling-a-wider-rollout