Pfizer and BioNTech Submit Application to US FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children under 5 Years

Pfizer Inc. and BioNTech SE announced they have submitted an application to the US FDA for emergency use authorization of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine as the third 3-µg dose in the three-dose primary series for children 6 months through 4 years of age.