Study Shows Positive Results for mRNA-Based Combination Influenza and COVID-19 Vaccine

A Phase I/II study evaluating the safety, tolerability and immunogenicity of Pfizer and BioNTech’s mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults 18 to 64 years of age show positive topline results.

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 the companies’ lead formulations demonstrated robust immune responses to influenza A, influenza B and SARS-CoV-2 strains. According to the companies, immunogenicity results induced by lead formulations in the companies’ trial showed point estimates for geometric mean titer (GMT) 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 >1 relative to a licensed quadrivalent influenza vaccine given concomitantly with the Pfizer-BioNTech COVID-19 vaccine.

“We are encouraged by these early results in our Phase I/II 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,” said Annaliesa Anderson, PhD, FAAM, senior vice president and head of vaccine research and development at Pfizer. “mRNA-based vaccines have demonstrated their ability to induce robust antibody and T-cell responses, and we look forward to starting Phase III clinical development. Today’s results are an important achievement towards our ambition of providing a broad portfolio of respiratory combination vaccines.”