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

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

Posted In: BriefsBiotechLarge CapNewsHealth CareFDAGeneral