Us-based pharmaceutical company Pfizer Inc. (NYSE: PFE) and Germany-based BioNTech SE (Nasdaq: BNTX) announced on Tuesday the US Food and Drug Administration (FDA) expanded emergency use authorisation (EUA) to include a booster dose after completion of the primary series of the Pfizer-BioNTech COVID-19 Vaccine in children 5 to 11 years of age.

The booster dose is given at least five months after the second dose of the two-dose primary series and is the same 10-microgram dose of the Pfizer-BioNTech COVID-19 Vaccine.

To date, more than 8 million 5- to 11-year-olds in the US have completed a primary series.

The expanded EUA is based on data from the Phase 2/3 clinical trial, which showed that a booster dose of the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group, generating neutralising antibodies against both the Omicron variant and wild-type SARS-CoV-2 virus regardless of prior SARS-CoV-2 infection. No new safety signals were observed. The third dose was well tolerated, with a safety profile similar to the two-dose primary series.

The companies have already submitted an application to the European Medicines Agency for a booster dose in this age group and are planning to file with other regulatory agencies around the world. The Pfizer-BioNTech COVID-19 Vaccine is currently the only COVID-19 vaccine authorised for use in the U.S. for children 5 to 11 years of age.