Pfizer, BioNTech announce ‘positive’ topline data for combo flu/COVID vaccine

Pfizer (PFE) and BioNTech SE (BNTX) announced “positive” topline results from a Phase 1/2 study evaluating the safety, tolerability and immunogenicity of mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults 18 to 64 years of age. In the clinical trial, the vaccine candidates were compared to a licensed influenza vaccine and the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine given at the same visit. The data from the trial showed that the companies’ lead formulations demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains. The topline results of the ongoing trial demonstrated that the combination formulations evaluated had a safety profile consistent with the safety profile of the companies’ COVID-19 vaccine. Immunogenicity results induced by lead formulations in the companies’ phase 1/2 trial showed point estimates for Geometric Mean Titer ratios that were consistent with the criteria applied to regulatory approved vaccines against the respective influenza and SARS-CoV-2 strains. Point estimates for GMT ratios for all matched influenza vaccine strains with lead formulations were greater than 1 relative to a licensed Quadrivalent Influenza Vaccine given concomitantly with the Pfizer-BioNTech COVID-19 vaccine. A pivotal Phase 3 trial evaluating these lead formulations is expected to be initiated in the coming months. Data from the Phase 1/2 trial will be published in a peer-reviewed journal. “We are encouraged by these early results in our Phase 1/2 study of our combination vaccine candidates against influenza and COVID-19. This vaccine has the potential to lessen the impact of two respiratory diseases with a single injection and may simplify immunization practices for providers, patients, and healthcare systems all over the world. mRNA-based vaccines have demonstrated their ability to induce robust antibody and T-cell responses, and we look forward to starting Phase 3 clinical development. Today’s results are an important achievement towards our ambition of providing a broad portfolio of respiratory combination vaccines,” said Annaliesa Anderson, PhD, FAAM, Senior Vice President and Head, Vaccine Research and Development at Pfizer.