Pfizer, BioNTech submit application to FDA for Omicron-specific COVID vaccine

Aug. 22, 2022 11:02 AM ETBioNTech SE (BNTX), PFEBy: Jonathan Block, SA News Editor22 Comments

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  • Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) have submitted an application for an Emergency Use Authorization to the US FDA of their Omicron-specific bivalent COVID-19 vaccine.
  • The shot contains protection against the original COVID strain as well as against the BA.4 and BA.5 Omicron subvariants, currently the two most dominant strains circulating in the US.
  • The companies are asking for approval in those 12 years and older.
  • The application is supported by data from a phase 2/3 trial against the BA.1 subvariant as well as preclinical data from the BA.4/BA.5-adapted bivalent vaccine. A clinical study of the bivalent vaccine is expected to begin this month.
  • The FDA will likely grant the authorization in the coming weeks given that the Biden administration has stated it wants to start administering the new vaccines in September.
  • White House COVID response coordinator Ashish Jha recently said that the federal government will stop purchases of COVID-19 vaccines, treatments, and tests as early as this fall.

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