Pfizer Starts Pivotal Phase 3 Study of mRNA-Based Influenza Vaccine

  • Pfizer Inc PFE has dosed the first participants in the Phase 3 trial of its quadrivalent modified RNA (modRNA) influenza vaccine candidate in approximately 25,000 healthy U.S. adults.
  • Influenza annually causes 140,000 to 710,000 hospitalizations, 12,000 to 52,000 deaths, and about $25 billion in economic loss in the U.S.
  • The quadrivalent modRNA vaccine candidate will encode World Health Organization recommended strains for the Northern Hemisphere 2022-23 cell culture- or recombinant-based influenza vaccines.
  • This Phase 3 study is informed by previously shared data from the ongoing Phase 2 trial, demonstrating a safety and immunogenicity profile supportive of program advancement.
  • Beyond the modRNA vaccine candidate, Pfizer has ongoing studies exploring more novel mRNA technology like self-amplifying RNA (saRNA).
  • In 2018, Pfizer entered into a worldwide collaboration and license agreement with BioNTech SE BNTX, under which Pfizer has the exclusive right to carry out the clinical development and commercialization of mRNA‐based influenza vaccines. 
  • BioNTech would receive a royalty on Pfizer’s sales upon potential approval and commercialization.
  • Price Action: PFE shares are down 0.13% at $46.13 during the premarket session on the last check Wednesday.
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