By Don Tracy, Associate Editor

Funding from the Biomedical Advanced Research and Development Authority (BARDA) is expected to support the late-stage development and licensure of a pre-pandemic vaccine targeting the H5 influenza virus.
The Biomedical Advanced Research and Development Authority (BARDA) has granted Moderna a $176 million project award under the Rapid Response Partnership Vehicle (RRPV) Consortium, with the goal of expediting the development of mRNA-based pandemic influenza vaccines. Reportedly, the award is expected to support the late-stage development and licensure of a pre-pandemic vaccine targeting the H5 influenza virus, a subtype known for causing severe avian influenza and posing a potential risk to humans.1
"mRNA vaccine technology offers advantages in efficacy, speed of development, and production scalability and reliability in addressing infectious disease outbreaks, as demonstrated during the COVID-19 pandemic," said Stéphane Bancel, CEO, Moderna, in a press release. "We are pleased to continue our collaboration with BARDA to expedite our development efforts for mRNA-based pandemic influenza vaccines and support the global public health community in preparedness against potential outbreaks."
Last year, Moderna initiated a Phase I/II study aiming to assess the safety and immunogenicity of its investigational pandemic influenza vaccine (mRNA-1018) in adults, with results expected this year to influence plans for Phase III. In October, the company announced encouraging results from the trial.1,2
The ongoing trial is a randomized, observer blind study evaluating the safety and immunogenicity of mRNA-1083 compared to a standard dose influenza vaccine, Fluarix, in adults 50-64 years of age and against an enhanced influenza vaccine, Fluzone HD, in adults 65-79 years of age. Additionally, both groups will compare mRNA-1083 to Spikevax booster.
Results indicated that the mRNA-1083 candidate achieved hemagglutination inhibition antibody titers similar to or greater than both licensed quadrivalent influenza vaccines and achieved SARS-CoV-2 neutralizing antibody titers similar to the Spikevax bivalent booster. Additionally, the vaccine led to geometric mean titer (GMT) ratios >1.0 relative to Fluarix in adults 50-64 years of age, for all four influenza vaccine strains. Further, GMT ratios of mRNA-1083 relative to Spikevax bivalent were > 0.9 in adults 50 to 64 years of age and > 1.0 in adults 65 to 79 years of age, relative to Spikevax.2
"With today's positive results from our combination vaccine against flu and COVID-19, we continue to expand our Phase 3 pipeline," said Bancel, in a press release. "Flu and COVID-19 represent a significant seasonal burden for individuals, providers, healthcare systems and economies. Combination vaccines offer an important opportunity to improve consumer and provider experience, increase compliance with public health recommendations, and deliver value for healthcare systems. We are excited to move combination respiratory vaccines into Phase 3 development and look forward to partnering with public health officials to address the significant seasonal threat posed to people by these viruses."
According to data from the Centers for Disease Control and Prevention, there were an estimated 35-65 million cases of influenza during the 2023-2024 United States flu season. Additionally, there was an estimated 25,000 to 72,000 deaths, 16 million to 30 million medical visits, and 390,000 to 830,000 deaths.3
“The burden of flu disease in the United States can vary widely and is determined by a number of factors including the characteristics of circulating viruses, the timing of the season, how well the vaccine is working to protect against illness, and how many people got vaccinated,” reports the CDC. “While the effects of flu varies, it places a substantial burden on the health of people in the United States each year.”4
The project is funded by the Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), and BARDA.1