Pfizer, BioNTech Apply For EUA In US Of Omicron BA.4/BA.5-Adapted Bivalent Vaccine Booster In Kids

Pfizer Inc. (PFE) and BioNTech SE (BNTX) announced Monday that they have completed a submission to the U.S. Food and Drug Administration requesting Emergency Use Authorization or EUA of a 10-g booster dose of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age.

The request for EUA of the vaccine in this age group is supported by safety and immunogenicity data from the companies' bivalent Omicron BA.1-adapted vaccine, non-clinical and manufacturing data from the companies' 10-g bivalent Omicron BA.4/BA.5-adapted vaccine, and pre-clinical data from Omicron BA.4/BA.5-adapted vaccine in their decision.

The companies will also submit an application to extend the Omicron BA.4/BA.5-adapted bivalent vaccine marketing authorization to include children ages 5 through 11 years to the European Medicines Agency or EMA in the coming days.

Pfizer and BioNTech have also initiated a Phase 1/2/3 study NCT05543616 (C4591048) to evaluate the safety, tolerability, and immunogenicity of different doses and dosing regimens of the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children 6 months through 11 years of age.

The pediatric study, consistent with regulatory guidance, follows a previous Phase 1/2/3 trial involving these age groups that demonstrated the original Pfizer-BioNTech COVID-19 Vaccine is well-tolerated and offers a high level of protection against COVID-19, measured at a time when the Omicron BA.2 strain was highly prevalent.

The Pfizer-BioNTech COVID-19 Vaccine is based on BioNTech's proprietary mRNA technology. It was developed by both BioNTech and Pfizer.

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