Pfizer and BioNTech Provide Update on mRNA-Based Combination Vaccine Program Against Influenza and COVID-19 in People 18 to 64 Years

Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced topline results from their Phase 3 clinical trial evaluating the companies’ combination mRNA vaccine candidate against influenza and COVID-19 in healthy individuals aged 18 to 64 years. The combination candidate consists of Pfizer’s mRNA-based influenza vaccine candidate with the companies’ licensed COVID-19 vaccine. The Phase 3 trial measured two primary immunogenicity objectives (immunogenicity against SARS-CoV-2 and immunogenicity against influenza A and B), one of which was met. In a separate Phase 2 trial, Pfizer evaluated trivalent (“tIRV”) influenza mRNA standalone vaccine candidates that demonstrated robust immunogenicity in individuals aged 18 to 64 years. The companies are evaluating modifications to the combination vaccine candidate aimed at improving immune responses against influenza B and will discuss next steps with health authorities.

Update on Phase 3 Trial of Pfizer and BioNTech Combination Vaccine