• Lead formulations evaluated in the Phase 1/2 study demonstrated robust immune responses to influenza A, influenza B, and SARS-CoV-2 strains
• Safety profile of the mRNA-based combination vaccine candidates consistent with the companies’ COVID-19 vaccine
• The companies plan to start a pivotal Phase 3 trial in the coming months

NEW YORK & MAINZ, GERMANY--- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced positive topline results from a Phase 1/2 study (NCT05596734) 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.

“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,” said Annaliesa Anderson, PhD, FAAM, Senior Vice President and Head, 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 3 clinical development. Today’s results are an important achievement towards our ambition of providing a broad portfolio of respiratory combination vaccines.”

“Studies of confirmed viral infections suggest that COVID-19 adopts a seasonal pattern with peaks in fall and winter, similar to other respiratory diseases. Co-infections as well as consecutive respiratory infection during this period can further increase the risk of severe illness,” said Prof. Ugur Sahin, MD, CEO and Co-founder of BioNTech. “Combination vaccines have the potential to become a mainstay of routine vaccination against respiratory diseases, especially for the vaccination of populations who have a higher risk of severe illness.”

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 (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 (QIV) 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.

Pfizer and BioNTech previously announced that their mRNA-based combination vaccine candidate for influenza and COVID-19 received Fast Track Designation from the U.S. Food and Drug Administration (FDA).

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