Influenza (flu) causes approximately five million cases of severe illness and 290,000 to 650,000 deaths worldwide each year.¹ Current seasonal flu vaccines prevent only 40 percent to 60 percent of the disease in the best-matched seasons.²

Messenger RNA, or mRNA, has the potential to improve this situation. For decades, mRNA therapeutics seemed more promise than reality. But Pfizer and BioNTech’s swift development and delivery of the world’s first mRNA-based vaccine for COVID-19 highlighted mRNA as a potent vaccine platform, and we believe this technology has the potential to help prevent or treat other diseases, including flu.

“Since 2018, we have been working to develop a potential mRNA influenza vaccine, driven by our deep understanding of infectious diseases and our extensive experience in researching, developing, and implementing new vaccine technologies to help prevent infectious diseases,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer. “The COVID-19 pandemic allowed us to demonstrate the immense scientific opportunity that mRNA might have for a variety of diseases. Influenza remains an area where we think a vaccine with improved efficacy in any given season could make a real difference in people’s lives, and we believe mRNA is the ideal technology to take on this challenge.”

Relative to the technologies used to manufacture the flu vaccines currently available that require the use of chicken eggs or mammalian cells, the manufacturing processes for any potential mRNA-based flu vaccine, if successfully developed and licensed, would also be simpler and faster. These traditional technologies, where the virus must replicate, take months, creating a potential stumbling block for fast delivery of seasonal vaccines. Because mRNA can be manufactured in a relatively short time frame, an mRNA vaccine for flu could potentially allow for manufacturers to better match the strains in circulation in any given season, perhaps leading to greater efficacy, subject to regulatory approval.

In September 2021, we announced that the first participants were dosed in a Phase 1 exploratory clinical trial to evaluate the safety, tolerability, and immunogenicity of a single dose quadrivalent mRNA vaccine against influenza in healthy adults.

In addition, the study is designed to address fundamental questions that will help in the design of the vaccine. Our mRNA influenza vaccine program is the first in a planned wave of programs leveraging mRNA technology for influenza.

We believe mRNA represents a new frontier in health care, and we are committed to continuing to advance the technology to unlock its full power for the benefit of patients everywhere.