Breaking: FDA Authorizes Pfizer-BioNTech Booster Shot for Children Ages 5 to 11

In a newly released statement,¹ the FDA announced the amendment of the current emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, now authorizing a single booster dose for children 5 to 11 years of age, at least 5 months after completing the primary Pfizer-BioNTech vaccine series.

This EUA amendment follows the January 3, 2022 authorization for adolescents aged 12 to 15 years and joins the approval of Comirnaty (COVID-19 vaccine, mRNA) for use in those aged 16 and older.

The agency analyzed immune response data in a subset of children age 5 to 11 collected from the ongoing randomized, placebo-controlled trial that supported the October 2021 authorization of the vaccine in this age group. Researchers evaluated antibody responses in 67 participants who received their booster dose 7 to 9 months following the completion of a 2-dose primary vaccine series.

Safety was assessed in 400 children who received a booster dose at least 5 months after their 2-dose primary series. The most commonly reported adverse effects included pain, injection site redness and swelling, and fatigue, headache, muscle or joint pain, and chills and fever.

“[T]he omicron wave has seen more kids getting sick with [COVID-19] and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” said Robert M. Califf, MD, FDA Commissioner. “The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age to provide continued protection against COVID-19.”

“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,” added Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Research. “Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose…in all authorized populations.”

“The FDA has determined that the known and potential benefits of a single booster dose…for children 5 through 11 years of age at least 5 months after completing a primary series outweighs its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups,” he continued.

Vaccination, Califf said, remains the most effective way to prevent COVID-19 and related severe consequences.

Reference

1. Coronavirus (COVID-19) update: FDA expands eligibility for Pfizer-BioNTech COVID-19 vaccine booster dose to children 5 through 11 years. News release. FDA. May 17, 2022. Accessed May 17, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-pfizer-biontech-covid-19-vaccine-booster-dose