The U.S. Food and Drug Administration expanded the emergency use authorization (EUA) for the Pfizer-BioNTech Covid-19 Vaccine to prevent coronavirus to include adolescents 12 through 15 years of age.
“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. 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.”
From March 1, 2020, through April 30, about 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the Centers for Disease Control and Prevention. Children and adolescents generally have milder Covid-19 cases when compared to adults. The Pfizer-BioNTech vaccine is administered in two doses, three weeks apart, the same dosage and dosing regimen for 16 years of age and older.
The issuance of a EUA is not an FDA approval of a vaccine. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics to prevent and treat Covid-19 is terminated. It may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance or to protect public health or safety.