Pfizer and BioNTech update on mRNA-based combination vaccine program against Influenza and Covid-19

In a Phase 3 trial, Pfizer and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicity objectives

Pfizer and BioNTech SE announced top-line results from their Phase 3 clinical trial to evaluate the companies’ combined mRNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age.

The combination candidate consists of Pfizer’s mRNA-based influenza vaccine candidate with the companies’ licensed COVID-19 vaccine. The Phase 3 trial measured two primary immunogenicity objectives (immunogenicity against SARS-CoV-2 as well as immunogenicity against influenza A and B), of which one was met.

In a separate Phase 2 trial, Pfizer evaluated trivalent (tIRV) influenza mRNA standalone vaccine candidates which demonstrated robust immunogenicity in individuals 18-64 years of age. The companies are evaluating adjustments to the combination vaccine candidate aimed at improving immune responses against influenza B and will discuss next steps with health authorities.

“We are encouraged by the robust immunogenicity we saw with our combination vaccine against influenza A, which was similar to what we had seen for our initial quadrivalent influenza vaccine where we saw superior relative vaccine efficacy against a comparator flu vaccine,” said Annaliesa Anderson, PhD, Senior Vice President and Head, Vaccine Research and Development at Pfizer. “We are committed to developing vaccines that will reduce the burden of respiratory diseases and believe that combination vaccines are the most efficient way to do this. Today’s results provide insight and direction towards achieving this goal, and we remain optimistic about our combination COVID-19 and influenza program, for which we are evaluating the next steps.”

“We are dedicated to developing combination vaccines which provide broader protection against multiple respiratory diseases,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “The insights gained from this combination vaccine trial are highly valuable and will play a crucial role in guiding the further development of Pfizer’s and our combination vaccine program against influenza and COVID-19. We are committed to drawing on our experience in developing mRNA-based vaccine candidates against multiple antigens and believe we can successfully accomplish this task in collaboration with our partner Pfizer.”