The U.S. Food and Drug Administration (FDA) on Tuesday expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include a single booster shot for children aged 5–11. The shot can be received no earlier than 5 months after receiving the primary series of the vaccine, according to the agency’s press release.
“The Pfizer-BioNTech COVID-19 Vaccine is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
The FDA said its analysis was conducted on a group of children from a randomized placebo-controlled trial following the authorization of October 2021 for the Pfizer-BioNTech COVID-19 vaccine primary series in this age group.
The trial included 67 participants who were administered a booster shot approximately 7–9 months following their primary series. The level of antibodies against the SARS-CoV-2 virus appeared to increase after the booster shot in comparison to the level of antibodies prior to administering the booster shot, FDA said. Approximately 400 children aged 5–11 were involved in the assessment for the safety of the single booster dose of the Pfizer-BioNTech COVID-19 vaccine following the completion of the two-dose primary vaccine series, FDA added.
The Pfizer-BioNTech COVID-19 Vaccine already has full FDA approval for use in adults. Pfizer said it would request this EUA in April.