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.