Submission to European Medicines Agency for Omicron BA.4/BA.5-adapted Bivalent Vaccine booster in children 5 through 11 years of age
Pfizer Inc. and BioNTech SE announced they have completed a submission to the European Medicines Agency (EMA) for a 10-µg booster dose of the companies’ 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 (MA) to include the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is supported by safety and immunogenicity data from the companies’ Omicron BA.1-adapted bivalent vaccine, non clinical and manufacturing data from the companies’ 10-µg Omicron BA.4/BA.5-adapted bivalent vaccine, and preclinical data from the companies’ Omicron BA.4/BA.5-adapted bivalent vaccine.
On September 26, the companies also completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children 5 through 11 years of age.
In addition, the companies have also initiated a Phase 1/II/III study (NCT05543616, C4591048) to evaluate the safety, tolerability and immunogenicity of different doses and dosing regimens of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age. This study is consistent with regulatory guidance and follows the design of the previous Phase 1/II/III trial to evaluate further options for protection in this age group.
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