The Food and Drug Administration (FDA) has authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine as a single booster dose to be administered to individuals 5 to 11 years of age at least 5 months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine.

The revised Emergency Use Authorization (EUA) was based on the FDA’s analysis of immune response data from an ongoing randomized placebo-controlled trial (ClinicalTrials.gov Identifier: NCT04816643) that assessed the safety, tolerability and immunogenicity of a third dose (10µg booster) in 140 children 5 to 11 years of age approximately 6 months after receiving the second dose of the 10µg primary series. Antibody responses were evaluated in 67 participants who received a booster dose 7 to 9 months after completing a 2-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine.

Immunogenicity data from the study showed a 6-fold increase in SARS-CoV-2 wild-type strain-neutralizing geometric mean titers (GMTs) 1 month after the booster compared with GMTs 1 month after the second dose, in children with no evidence of prior SARS-CoV-2 infection. Data from a subanalysis of 30 human immune sera demonstrated that following a third dose, a 36-fold increase in SARS-CoV-2 Omicron neutralizing antibody titers was observed in this age group.

As for safety, the Pfizer-BioNTech COVID-19 Vaccine was evaluated in approximately 400 children who received a booster dose at least 5 months (range 5 to 9 months) after completing a 2-dose primary series. The vaccine was well tolerated with the most commonly reported adverse reactions being pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

The Pfizer-BioNTech COVID-19 Vaccine is currently authorized for emergency use for active immunization to prevent COVID-19 disease in individuals 5 years of age and older.

“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, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “[…] The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least 5 months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups.”

A revised fact sheet for the Pfizer-BioNTech COVID-19 Vaccine can be found here.

Reference

Coronavirus (COVID-19) update: FDA expands eligibility for Pfizer-BioNTech COVID-19 vaccine booster dose to children 5 through 11 years. News release. US Food and Drug Administration. 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