FDA approves use of Pfizer vaccine in adolescents 12 to 15 years old

SILVER SPRING, MD – The U.S. Food and Drug Administration issued emergency use authorization for the Pfizer/BioNTech COVID-19 for individuals 12 years of age and older on Monday.

Previously, the Pfizer vaccine was only approved for individuals 16 years of age and older. Even before this new order, the Pfizer vaccine is the only vaccine approved for individuals below the age of 18.

The FDA said that they determined that Pfizer vaccine met the statutory criteria to amend the EUA, and that the known and potential benefits of the vaccine in individuals 12 years of age and older outweigh the known and potential risks.

The most commonly reported side effects in the adolescent clinical trial participants were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. The side effects typically only lasted 1-3 days.

“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, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our evaluation and decision-making process, the FDA can assure the public and medical community that the available data meet our rigorous standards to support the emergency use of this vaccine in the adolescent population 12 years of age and older.”