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FDA Sets Review Dates For Pfizer, Moderna COVID-19 Shot For Kids, Plus Novavax EUA

Benzinga · 04/29/2022 15:08
  • The FDA has set up June meeting dates to review COVID-19 vaccine submissions, noting that the dates are tentative as none of the submissions are complete.  
  • The agency reserved June 8, 21, and 22 for virtual meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review Moderna Inc (NASDAQ: MRNA) and Pfizer Inc (NYSE: PFE) - BioNTech SE (NASDAQ: BNTX) emergency use authorizations for younger age groups. 
  • On Thursday, Moderna submitted its emergency use authorization (EUA) for children aged six months to 6 years to the FDA. 
  • Pfizer/BioNTech have yet to do so.
  • In February, the FDA pulled back on its plan to authorize the Pfizer vaccine for children aged six months to 4 years as the agency asked for more information.
  • In addition, the FDA also slated June 7 for the panel to discuss Novavax Inc’s (NASDAQ:NVAXCOVID-19 vaccine emergency use submission
  • The FDA set June 28 to discuss whether the SARS-CoV-2 strain composition should be modified. The June meeting follows VRBPAC’s meeting this month that discussed general considerations. 
  • The FDA said that the discussion will include whether the strain should be modified, “and if so, which strain(s) should be selected for Fall 2022.”
  • Price Action: NVAX shares are up 2.91% at $45.56 during the market session on the last check Friday.