Pfizer and BioNTech Submit EUA Application for Pediatric COVID-19 Vaccine Booster Dose

Pfizer and BioNTech have submitted an application to FDA for Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children five through 11 years of age. The companies also plan to submit authorization applications to the European Medicines Agency (EMA) and other regulatory agencies around the world.

The companies submitted data from a clinical trial in children ages five through 11 years who received a booster dose approximately six months after the second dose of the Pfizer-BioNTech COVID-19 vaccine two-dose primary series, which was previously authorized under EUA for this age group in October 2021. The data demonstrated strong immune response in this age group following a booster dose of the vaccine.

The vaccine was developed by both BioNTech and Pfizer based on BioNTech’s proprietary messenger RNA technology. BioNTech is the marketing authorization holder in the United States, the European Union, the United Kingdom, Canada, and equivalent authorizations in other countries.