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Pfizer/BioNTech Seek FDA Emergency Nod For Updated COVID-19 Shot For Kids Under 11 Years

Benzinga Real-time News ·  Sep 26, 2022 07:54

  • Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have completed an FDA submission seeking Emergency Use Authorization (EUA) for a 10-μg booster dose for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age.

  • The emergency use request of the Omicron BA.4/BA.5-adapted bivalent vaccine in this age group is supported by safety and immunogenicity data from the companies' bivalent Omicron BA.1-adapted vaccine, non-clinical & manufacturing data, and pre-clinical data.

  • Related Content: Europe Backs Approval Of Omicron-Adapted COVID-19 Vaccines.

  • An application to extend the Omicron BA.4/BA.5-adapted bivalent vaccine for 5-11 years children will be submitted to the European Medicines Agency (EMA) in the coming days.

  • The companies have also initiated a Phase 1/2/3 study to evaluate the safety, tolerability, and immunogenicity of different doses and dosing regimens of Pfizer/BioNTech's Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine in children six months - 11 years.

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