On Apr. 26, 2022, Pfizer and BioNTech submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-ﾵg booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as children ages 5 through <12).

The submission included data from the Phase 2/3 clinical trial in children ages 5 through 11 years who received a booster dose approximately 6 months after the second dose of the Pfizer-BioNTech COVID-19 Vaccine 10-ﾵg two-dose primary series, which was authorized under EUA for this age group in October 2021.

The companies also plan to submit these data to the European Medicines Agency (EMA) and other regulatory agencies around the world for authorization in the coming weeks.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 5 years of age and older