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May 14, 2021

Health Law Weekly

Pfizer COVID-19 Vaccine Extended to 12-15 Age Group

  • May 14, 2021

The Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the COVID-19 vaccine developed by Pfizer Inc. and German partner BioNTech to include adolescents between the ages of 12 and 15, the agency announced May 10.

The FDA issued the original EUA to Pfizer in December 2020, authorizing its two-dose COVID-19 vaccine for those 16 years and older. Moderna Inc. and Johnson & Johnson’s COVID-19 vaccines currently are authorized for adults 18 years and older.  

“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,” said Acting FDA Commissioner Janet Woodcock, M.D.

On May 12, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices also voted 14-0, with one recusal, in favor of recommending Pfizer's vaccine for use in the 12-15 age group.