FDA committee approves SARS-CoV-2 vaccine for children aged 5-11

Oct. 27, 2021

The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the agency grant emergency use authorization (EUA) for use of the Pfizer-BioNTech COVID-19 vaccine in children 5 to 11 years of age, according to a news release from Pfizer. 

The committee reviewed the totality of scientific evidence shared by the companies, including results from a Phase 2/3 randomized, controlled trial that included more than 4,500 children 5 to 11 years of age (2,268 from the original group and 2,379 from the supplemental safety group). Participants in this age group received a two-dose regimen of 10-µg doses administered 21 days apart, one-third of the 30-µg dose used for people 12 years and older. The Phase 2/3 trial showed a favorable safety profile, robust immune responses and a vaccine efficacy rate of 90.7% in participants without prior SARS-CoV-2 infection, measured from 7 days after the second dose.

 Kathrin U. Jansen, PhD, Senior Vice President and Head of Vaccine Research & Development at Pfizer, said, “About 10% of all weekly U.S. cases occur in children 5 to under 12 years of age with a potential risk of complications.”

The FDA is expected to make its decision in the coming days. If authorized and subsequently recommended by the U.S. Centers for Disease Control and Prevention (CDC), the Pfizer-BioNTech COVID-19 vaccine will be the first COVID-19 vaccine available for use in children 5 to 11 years of age in the United States.

The companies expect to then begin shipping pediatric vaccine doses immediately, as directed by the U.S. government.

Pfizer and BioNTech have submitted requests for authorization of their COVID-19 vaccine in this age group to other regulators around the world, including the European Medicines Agency. Initial data from the other two age cohorts in the ongoing Pfizer-BioNTech clinical trial in children – those 2 to 4 years of age and those 6 months to <2 years of age – are expected as soon as fourth quarter 2021 or early first quarter 2022.

The Pfizer-BioNTech COVID-19 vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer.

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