FDA Authorizes Use of Pfizer BioNTech COVID 19 Vaccine for Ages 12-15

Today, the Food and Drug Administration (FDA) announced that the agency has amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to permit use of the vaccine in adolescents 12 to 15 years of age. As vaccination efforts in the United States continue, ASHP applauds the FDA decision, which expands our ability to help protect communities from COVID-19 and allows adolescents to begin receiving the vaccine now and over the summer so that they are immunized prior to the start of the next school year.  

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet May 12 to discuss recommendations for use of the vaccine in adolescents 12 to 15 years of age, and the CDC is expected to issue clinical considerations for this age group.

Under the Public Readiness and Emergency Preparedness (PREP) Act, state-licensed pharmacists, supervised state-licensed pharmacy interns, and qualified pharmacy technicians acting under a qualified licensed pharmacist’s supervision can administer COVID-19 vaccines licensed or authorized by the FDA and in accordance with the CDC ACIP recommendations to patients 3 years of age and older.

Data released by Pfizer-BioNTech in late March showed that the companies’ COVID-19 vaccine demonstrated 100% efficacy and was well tolerated in a clinical trial that enrolled more than 2,000 adolescents 12 to 15 years of age in the U.S. The FDA said it determined the Pfizer-BioNTech 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, supporting the vaccine's use in this population.

ASHP anticipates vaccinations in adolescents 12 to 15 years of age to begin soon. Updated Patient Medication Information for the Pfizer-BioNTech COVID-19 vaccine that addresses this age group will be available from ASHP shortly in English and Spanish. The FDA has updated the Fact Sheets for Healthcare Providers Administering the Vaccine and the Fact Sheets for Recipients and Caregivers. 

Cumulatively, adolescents and children represent about 12% of overall COVID-19 cases, according to demographic data from the CDC. However, recently reported data collected by the American Academy of Pediatrics and Children’s Hospital Association through April 29 has shown a recent increase in pediatric cases, with 22% of new COVID-19 cases reported in adolescents and children.

Safety and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine also is being studied in younger children, and the manufacturers have said they expect to have data available by September to file an EUA request for use in children ages 2 to 11 and will have data available at a later date for use in children ages 6 months to 2 years. The FDA's Vaccines and Related Biological Products Advisory Committee will convene virtually June 10 to discuss pediatric use of COVID-19 vaccines, including data needed to support an EUA for a COVID-19 vaccine intended for use in children under age 12.