This computer-generated image shows influenza virus hemagglutinin epitopes arrayed on a nanoparticle. [Image courtesy of NIAID]
Big Pharma behemoth Pfizer (NYSE: PFE) has dosed the first participants in a pivotal Phase 3 clinical trial to test its quadrivalent modified RNA (modRNA) influenza vaccine candidate.
The mRNA flu vaccine study will enroll roughly 25,000 healthy U.S. adults.
Pfizer is not the only company to develop an mRNA flu vaccine. In December, Moderna (Nasdaq:MRNA) announced positive interim data from a Phase 1 study of its quadrivalent seasonal flu vaccine candidate, mRNA-1010. That data, however, disappointed investors, as mRNA-1010 had a similar performance to Sanofi’s (NSDQ:SNY) Fluzone HD flu vaccine.
Moderna’s (Nasdaq:MRNA) mRNA-1010 flu vaccine is now in a Phase 3 study. That study is fully enrolled with approximately 6,000 participants. Moderna anticipates the vaccine could have an accelerated pathway for approval.
Moderna is also developing a combined SARS-CoV-2 and influenza vaccine known as mRNA-1073, as well as mRNA-1230, a vaccine targeting SARS-CoV-2, influenza, and respiratory syncytial virus.
Pfizer is upbeat about the potential of its mRNA flu vaccine to “deliver an improved flu vaccine to help address the significant burden of this disease,” said Annaliesa Anderson, senior vice president and chief scientific officer, vaccine research and development at Pfizer.
Typical flu vaccines are generally anywhere from 40% to 60% effective against circulating influenza virus strains, according to CDC. Last year, the seasonal flu vaccine was about 16% effective, according to The New York Times.
The modularity of the mRNA platform could enable drug developers to develop flu vaccines more nimbly than older platforms. To date, FDA has approved flu vaccines that are egg-based, cell-based and recombinant.
For its quadrivalent modRNA vaccine candidate, Pfizer plans on encoding WHO-backed strains for the Northern Hemisphere 2022-23 cell culture- or recombinant-based influenza vaccines.
Pfizer is also exploring other types of mRNA technology, including self-amplifying RNA (saRNA).
Pfizer’s mRNA-based influenza vaccine program is based on a 2018 collaboration and license agreement with BioNTech (Nasdaq:BNTX).
Last year, Pfizer’s and BioNTech’s COVID-19 vaccine generated $59 billion in cumulative revenue.
Between 3 and 5 million people develop severe flu infections globally each year, according to WHO.