The U.S. Food and Drug Administration’s (FDA) top vaccine official told a congressional committee on Friday that COVID-19 vaccines for kids under 6 will not have to meet the agency’s 50% efficacy threshold required to obtain Emergency Use Authorization (EUA).
The FDA is reviewing data from Moderna’s two-shot vaccine for infants and toddlers 6 months to 2 years old, and for children 2 to 6 years old. The agency is awaiting data on Pfizer and BioNTech’s three-dose regimen for children under age 5 after two doses of its pediatric vaccine failed to trigger an immune response in 2-, 3- and 4-year-olds comparable to the response generated in teens and adults.
According to Endpoints News, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, told the House Select Subcommittee on the Coronavirus Crisis the agency would not withhold authorization of a pediatric vaccine if it fails to meet the agency’s 50% efficacy threshold for blocking symptomatic infections.