The U.S. Food and Drug Administration on Monday expanded the emergency use authorization for the Pfizer COVID-19 vaccine to include children 12 through 15 years of age. However, vaccines are not expected to be available to that age group until the CDC also recommends such usage.
This marks the first COVID-19 vaccine authorized in the U.S. for that age group. Pfizer’s vaccine had previously been authorized for people aged 16 and older.
An advisory committee of the Centers for Disease Control and Prevention is expected to meet this week to advise the CDC on whether or not to recommend the vaccine’s use in people 12-15 years old.
In making the decision to expand authorization, the FDA reviewed available safety data from Pfizer. The clinical trial included 2,260 participants 12-15 years old, and the vaccine proved 100% effective.
According to the FDA, the most commonly reported side effects — which lasted 1-3 days — were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain.
Acting FDA Commissioner Janet Woodcock called the expanded authorization “a significant step in the fight against the COVID-19 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,” Woodcock said.
