Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced positive topline results from a Phase 1/2 study (NCT05596734) evaluating their mRNA-based combination vaccine candidates for influenza and COVID-19 among healthy adults aged 18 to 64. The lead formulations demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains. These findings were based on comparison with a licensed influenza vaccine and the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine administered concurrently.
The Phase 1/2 study, which aimed to assess safety, tolerability, and immunogenicity, revealed a safety profile consistent with the companies’ COVID-19 vaccine. Lead formulations induced immunogenicity results with Geometric Mean Titer (GMT) ratios consistent with regulatory-approved vaccines for influenza and SARS-CoV-2 strains. Point estimates for GMT ratios for matched influenza vaccine strains exceeded 1 relative to a licensed Quadrivalent Influenza Vaccine (QIV) administered concurrently with the Pfizer-BioNTech COVID-19 vaccine.
Annaliesa Anderson, PhD, FAAM, Senior Vice President and Head of Vaccine Research and Development at Pfizer, expressed encouragement for the promising Phase 1/2 results. The combination vaccine, designed to combat both influenza and COVID-19 with a single injection, holds the potential to simplify immunization practices globally.
Prof. Ugur Sahin, MD, CEO, and Co-founder of BioNTech highlighted the potential of combination vaccines becoming a staple in routine vaccination against respiratory diseases, especially for populations at a higher risk of severe illness. Given the seasonal pattern of COVID-19, the prospect of combination vaccines offers increased protection.
The companies announced plans to initiate a pivotal Phase 3 trial in the coming months. The Phase 1/2 trial data, showcasing the safety and immunogenicity of the combination vaccine, is expected to be published in a peer-reviewed journal.
Pfizer and BioNTech had previously secured Fast Track Designation from the U.S. Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and COVID-19.