Pfizer begins Phase 3 clinical trial of mRNA-based Influenza vaccine
New York: Pfizer Inc. has announced that the first participants have been dosed in a pivotal Phase 3 clinical trial to evaluate the efficacy, safety, tolerability and immunogenicity of the company's quadrivalent modified RNA (modRNA) influenza vaccine candidate in approximately 25,000 healthy U.S. adults.
"For years, there has been a need to better address the burden of influenza, despite the use of existing seasonal flu vaccines. Our experience with RNA viruses and mRNA technology has given us an even deeper understanding of the opportunity to potentially provide more efficacious vaccines that could further reduce the yearly rates of the severe outcomes of viral disease like flu, including hospitalization and death," said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. "We are excited to start the first Phase 3 efficacy study of an mRNA-based influenza vaccine that could potentially deliver an improved flu vaccine to help address the significant burden of this disease."
Each year, even when currently available vaccine strains match circulating influenza virus strains well, those vaccines typically confer only 40% to 60% protection, with even lower protection in years with poor matching of strains. With circulating influenza strains continually changing, predicting the best match for the next season's vaccine is difficult for global health experts as those strains are chosen more than six months before the start of the influenza season that they target. The flexibility of mRNA technology and its rapid manufacturing could potentially allow better strain matches in future years, and in a pandemic influenza situation, mRNA technology could allow rapid, large-scale manufacturing of vaccines. mRNA-based influenza vaccines require only the genetic sequence of the virus.
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