On December 5, Pfizer and BioNTech announced that they have submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, intended as a booster shot for children aged 6 months to 4 years.
Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine is currently authorized in the United States and the European Union as a booster for children aged 5 years and older. The two companies are in discussions with the European Medicines Agency to expand the marketing authorization of the bivalent vaccine in the EU to include children aged 6 months to 4 years.