Pfizer and BioNTech Granted EUA for Booster Dose of COVID-19 Vaccine in Young Children

Pfizer and BioNTech announced that FDA has expanded emergency use authorization (EUA) to include a booster dose after completion of the primary series of the companies’ COVID-19 vaccine in children five through 11 years of age. The booster dose should be given at least five months after the second dose of the two-dose primary series. More than 8 million children aged 5–11 years old have completed a primary series of the vaccine in the United States to date.

The EUA is based on data that show children five through 11 years of age had a significant immune response following a booster dose of the vaccine during the time when Omicron was the prevalent variant. More than 4,000 children in this age range have participated in the companies’ COVID-19 vaccine clinical trial to date.

The companies have also submitted an application to the European Medicines Agency for a booster dose in this age group and plan to file similarly with other regulatory agencies around the world. The Pfizer-BioNTech COVID-19 vaccine is currently the only COVID-19 vaccine authorized for use in the US for children in this age group. The vaccine is based on BioNTech’s proprietary mRNA technology, and the company is the Marketing Authorization Holder in the US, European Union, the UK, and Canada. BioNTech and Pfizer jointly hold EUAs or equivalents in the US and other countries.