FDA Authorizes Pfizer COVID-19 Vaccine in Adolescents

The US Food and Drug Administration has authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents aged 12 through 15 years. This expands the original emergency use authorization issued on December 11, 2020, for use in patients aged 16 years and older.

The decision comes following an evaluation of safety data from 2260 participants aged 12 to 15 years from an ongoing, randomized, placebo-controlled clinical trial in which 1131 individuals received the vaccine and 1129 received placebo. The most common adverse effects included injection site pain, tiredness, headache, chills, muscle pain, fever, and joint pain. These effects were consistent with those reported in individuals aged 16 years and older.

The effectiveness was evaluated in a review which compared immune response in 190 participants aged 12 to 15 years with that of 170 participants aged 16 to 25 years. Overall, it showed that the response was non-inferior to that seen in older participants.

“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research.

—Michael Potts

Reference:

Coronavirus (COVID-19) Update: FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic. US Food and Drug Administration; May 10, 2021. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pfizer-biontech-covid-19-vaccine-emergency-use