On Sept. 28, 2022, Pfizer and BioNTech announced they had completed a submission to the European Medicines Agency for a 10-ﾵg booster dose of the companiesﾒ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children 5 through 11 years of age.

This application for a variation of the marketing authorization to include the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group was supported by safety and immunogenicity data from the companiesﾒ Omicron BA.1-adapted bivalent vaccine, non-clinical and manufacturing data from the companiesﾒ 10-ﾵg Omicron BA.4/BA.5-adapted bivalent vaccine, and preclinical data from the companiesﾒ Omicron BA.4/BA.5-adapted bivalent vaccine.