Pfizer and BioNTech Provide Update on mRNA-based Combination Vaccine Program Against Influenza and COVID-19 in Individuals 18-64 Years of Age

Core Insights - Pfizer and BioNTech's Phase 3 trial for a combination vaccine against influenza and COVID-19 met one of its two primary immunogenicity objectives, specifically achieving robust responses against influenza A and comparable responses against COVID-19, but did not meet the non-inferiority objective for the influenza B strain [1][2][3] - The companies are considering adjustments to the combination vaccine candidate and will engage with health authorities regarding next steps [1][2] - Pfizer's separate Phase 2 trial for a second-generation trivalent influenza mRNA vaccine showed promising results, demonstrating strong immunogenicity against all strains compared to standard influenza vaccines [1][5] Phase 3 Trial Details - The Phase 3 trial enrolled over 8,000 adults aged 18-64 to assess the safety, tolerability, and immunogenicity of a single-dose combination vaccine [2] - The trial compared the combination vaccine to a licensed influenza vaccine and the companies' licensed COVID-19 vaccine, focusing on antibody responses to both influenza and SARS-CoV-2 [2] - The combination vaccine elicited robust responses for influenza A but lower geometric mean titers for influenza B, while showing comparable responses against SARS-CoV-2 [2] Company Statements - Pfizer expressed optimism about the results, highlighting the robust immunogenicity against influenza A and the commitment to developing vaccines that address respiratory diseases [3] - BioNTech emphasized the importance of the insights gained from the trial for future development of combination vaccines [3] Phase 2 Trial Insights - Pfizer's Phase 2 trial for second-generation influenza vaccines involved 450 participants and aimed to improve immunogenicity and breadth of protection [5] - The new trivalent formulations showed strong responses against influenza A and B, with no safety signals reported [5] Industry Context - Influenza causes significant health burdens in the U.S., with annual hospitalizations ranging from 140,000 to 710,000 and deaths between 12,000 and 52,000, leading to economic losses of approximately $25 billion [7] - Current influenza vaccines typically provide 40% to 60% protection, with lower efficacy in years of poor strain matching, highlighting the need for improved vaccine technologies like mRNA [7]