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FDA Authorizes Pfizer/BioNTech’s COVID-19 Vaccine for 12 to 15 Year Olds

by Rajaneesh K. Gopinath
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On May 10th, the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) of Pfizer/BioNTech’s BNT162b2 to prevent COVID-19 in teens and adolescents. The agency amended the original EUA granted on December 11th, 2020, to include individuals ages 12 to 15.

BNT162b2 was the first COVID-19 vaccine to receive emergency approval in the US for people 16 years and up. With this expansion, the mRNA vaccine also becomes the first to be FDA approved for the 12-15 age group.

“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, M.D.

 

Return to Normalcy

The CDC notes that at least 1.5 million COVID-19 cases have been reported in individuals 11 to 17 years of age since March 2020. Although the infection is milder in children than adults, those with underlying medical conditions are still at risk for contracting severe COVID-19. Besides, they can also spread the virus to others just as adults. This vaccine approval would help young teens who have spent over a year in isolation and virtual learning to return to normalcy gradually.

“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.” Woodcock added.

In late March, Pfizer reported that the vaccine showed 100% efficacy in a trial conducted in the US with 2,260 participants. The FDA decided to expand the EUA after reviewing the available safety and efficacy data.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC), an independent panel of the FDA, did not convene to recommend the expansion. However, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Wednesday to advise the CDC to recommend vaccination for 12-to-15-year-olds. If greenlit by the panel, the vaccine will be available for the new age group as soon as Thursday in some states.

“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,” he added.

 

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