FDA Widens Pfizer-BioNTech COVID-19 Vaccine Indication to Include Adolescents

As expected, on Monday, the FDA expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12 through 15.

The EUA was first issued in December 2020 for individuals 16 years and older.

The safety data to support the decision come from an ongoing, randomized, placebo-controlled clinical trial of 2260 adolescents. Of these, 1131 received the vaccine and 1129 received a placebo. More than half of the participants were followed for safety for at least 2 months following the second dose. The trial is based in the United States.

The most commonly reported adverse effects (AEs), which lasted about 1 to 3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever, and joint pain.

As with adult recipients, AEs were more common and more pronounced after the second dose, which is given 3 weeks after the first.

“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, MD, in a statement. “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, 2021, approximately 1.5 million COVID-19 cases in individuals 11 to 17 years of age have been reported to the CDC. Compared with adults, children and teens generally have milder illness, but rare complications can develop.

In its announcement, the FDA released a fact sheet for recipients and caregivers as well as one for health care providers.