An application for Emergency Use Authorization (EUA) of a 10µg booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age has been submitted to the Food and Drug Administration.

The submission includes data from a phase 2/3 clinical 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.

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. Additionally, no new safety signals were reported.

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.

Data from an ongoing study in children 6 months to under 5 years of age are expected later this quarter. The Companies announced earlier this year that they would wait on data evaluating a 3-dose regimen in this age group prior to seeking an EUA amendment.

Reference

Pfizer and BioNTech submit application for US Emergency Use Authorization for a COVID-19 vaccine booster dose in children 5 through 11 years of age. News release. April 26, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-application-us-emergency-use