FDA expands Pfizer COVID-19 vaccine EUA

The Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) for the Pfizer COVID-19 vaccine to allow administration to patients between 12 and 15 years of age.

According to a news release, between March 1, 2020 and April 30, 2021, about 1.5 million patients 11 to 17 years of age contracted COVID-19 and they usually have milder symptoms.

“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,” acting FDA Commissioner Janet Woodcock, MD, says in the release. “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.”

Previously, Pfizer announced it had initiated the biologics license application for approval of their COVID-19 vaccine. Since the vaccine became the first to receive emergency use authorization from the Food and Drug Administration (FDA) in December, 170 million doses have been delivered across the country. The biologics license application is the next step in the FDA review process.