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FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Children
FDA based its decision on a Phase 2/3 trial that found two doses of the Pfizer-BioNTech COVID-19 vaccine to 90.7% effective in preventing COVID-19 in children aged five to 11.
FDA recently granted emergency use authorization to Pfizer and BioNTech’s COVID-19 vaccine for children five through 11 years of age.
The agency based its decision on data from a Phase 2/3 clinical trial and input from independent advisory committee experts who voted to make the vaccine available for pediatric patients.
In September, the trial found that two doses of the Pfizer-BioNTech vaccine were 90.7 percent effective in preventing COVID-19 in 3,100 children aged five to 11 years old.
Additionally, the SARS-CoV-2 neutralizing antibody geometric mean titer was 1,197, demonstrating a strong immune response one month after the second dose. Notably, researchers have detected no side effects in the trial.
“As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today’s authorization. Vaccinating younger children against COVID-19 will bring us closer to returning to a sense of normalcy,” Acting FDA Commissioner Janet Woodcock, MD, said in the announcement.
“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards,” Woodcock continued.
Pediatric patients aged five to 11 years in the US make up 39 percent of COVID-19 cases in individuals younger than 18 years of age. And about 8,300 coronavirus cases in this age group require hospitalization.
Under the authorization, caregivers can administer ten micrograms of the vaccine to children as a two-dose primary series, three weeks apart. The CDC’s Advisory Committee on Immunization Practices will meet next week to discuss further clinical recommendations.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, emphasized that the agency is confident in the safety, effectiveness, and manufacturing data behind the authorization.
Additionally, FDA is hopeful the new information builds the confidence of parents deciding whether to have their children vaccinated.
