Pfizer Inc. (NYSE: PFE) announced today 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.2 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.
Influenza annually causes 140,000 to 710,000 hospitalizations, 12,000 to 52,000 deaths3 and about $25 billion in economic loss in the U.S.4 The impact of flu on racial and ethnic minority groups in the U.S. is even larger. Black Americans are 1.8 times more likely than their white counterparts to be hospitalized for flu while Latino and Indigenous Americans are 1.2 and 1.3 times more likely, respectively.5 Although vaccination remains one of the best ways to help prevent infection and serious illness, racial and ethnic minority communities in the U.S. continue to be vaccinated at lower rates,6 and clinical trial enrollment for new or improved vaccines tend to lack diversity.7 Pfizer made a public commitment to help reduce health disparities through its clinical trials and ensure that Pfizer's clinical study populations fully represent the racial and ethnic diversity of the countries where trials are conducted.
About Pfizer's mRNA-based Flu Vaccine Program
The quadrivalent modRNA vaccine candidate will encode World Health Organization recommended strains for the Northern Hemisphere 2022-23 cell culture- or recombinant-based influenza vaccines.8 Additional information about the study can be found at www.clinicaltrials.gov.
This Phase 3 study is informed by previously shared data from the ongoing Phase 2 trial which demonstrates a safety and immunogenicity profile supportive of program advancement and is part of Pfizer's broader influenza vaccine program, focused on leveraging mRNA technology in a vaccine to help protect against the flu. Beyond the modRNA vaccine candidate, Pfizer has ongoing studies exploring more novel mRNA technology like self-amplifying RNA (saRNA), which has the potential to provide added benefit in the future.
In 2018, Pfizer entered into a worldwide collaboration and license agreement with BioNTech under which Pfizer has the exclusive right to carry out the clinical development and commercialization of mRNA‐based influenza vaccines. Upon potential approval and commercialization, BioNTech would receive a royalty on Pfizer's sales.
