- Pfizer Inc PFE and BioNTech SE 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.
- Price Action: PFE shares are down 0.75% at $43.75, and BNTX stock is down 1.34% at $126.63 during the premarket session on the last check Monday.
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