Pfizer-BioNTech COVID-19 Vaccine Approved for Minors Ages 12-15

The U.S. Food and Drug Administration (FDA) on Monday expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include adolescents ages 12 through 15. The FDA amended the EUA originally issued for the vaccine on December 11, 2020, for administration of the vaccine in individuals 16 years of age and older.

Based on available safety data for the vaccines, the FDA determined the immune response of adolescents was at least as good as the immune response of older participants and the vaccine is 100 percent effective in preventing COVID-19 among individuals ages 12 through 15.

On Wednesday, the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) convened a meeting to review the FDA’s expanded EUA for the vaccine. The ACIP unanimously endorsed the safety and efficacy of the vaccine among individuals 12 through 15 and recommended the CDC Director approve the use of the Pfizer-BioNTech vaccine nationwide. CDC Director Rochelle Walensky, shortly after the ACIP meeting, adopted the recommendation.

On Wednesday evening, the Western States Scientific Review Workgroup met to review the evidence from the Pfizer-BioNTech clinical trial among minors and, similar to the FDA and CDC, endorsed its safety and efficacy. The workgroup released a statement clearing the way for the vaccine to be administered among minors statewide.

The California Department of Public Health (CDPH) notes that approximately 2.1 million Californians in this age group are now available to be vaccinated against COVID-19. The state’s MyTurn COVID-19 vaccine registration site has been updated to allow parents, guardians, and emancipated minors to schedule a vaccine appointment.

Additional information, including the Western States Workgroup statement, from CDPH is available here.