The phase 2/3 trial showed a favorable safety profile, robust immune responses and a vaccine efficacy rate of 90.7% in children 5 to 11 years of age.
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 17 to 0, with one abstention, to recommend the agency grant an emergency use authorization (EUA) for the Pfizer and BioNTech’s COVID-19 vaccine in children 5 to 11 years of age.
The committee reviewed the totality of scientific evidence shared by the companies, including results from a phase 2/3 trial that included about 4,500 children 5 to 11 years of age.
The dose used was one-third of the dose given to people 12 years and older. The study enrolled 2,268, as well as 2,379 from a supplemental safety group. Participants received a two-dose regimen of 21 days apart. Pfizer leaders indicated the dose level was selected based on safety, tolerability and immunogenicity data evaluated as part of a dose-ranging study.
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 seven days after the second dose.
If authorized, the 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.
“COVID-19 is an ongoing threat for the more than 28 million young children in this age group in the United States, as they remain at risk for this infection. About 10% of all weekly U.S. cases occur in children 5 to under 12 years of age with a potential risk of complications,” Kathrin U. Jansen, Ph.D., senior vice president and head of vaccine research & development at Pfizer, said in a statement.
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.