The U.S. government has announced a significant investment of $176 million to Moderna for the development of a pandemic influenza vaccine using mRNA technology. This funding aims to address the growing concern over bird flu cases in dairy cows across the country. The funds will be released through the U.S. Department of Health and Human Services (HHS) and are part of an initiative by the Biomedical Advanced Research and Development Authority (BARDA), which focuses on medical treatments for potential pandemics.
Moderna will use this funding to continue the development of a vaccine that employs the same mRNA technology that was pivotal in the rapid development and rollout of COVID-19 vaccines. The company plans to launch trials to test the safety and effectiveness of this new vaccine, which could be scaled up in response to a bird flu pandemic if necessary.
The H5N1 virus, which was detected earlier this year in dairy cows, has spread to more than 135 herds in 12 states and has infected three people to date, all of whom experienced mild cases. Federal health officials emphasize that the risk to the wider population remains low, but the development of a vaccine is a proactive measure to mitigate potential future threats.
The new funds from HHS will support the continued development of the vaccine, including a late-stage trial next year if early study results are positive. The project is designed to be flexible and can be quickly redirected to target another form of influenza if a different threat emerges. This adaptability is crucial in addressing the ever-evolving landscape of infectious diseases.
Moderna’s bird flu vaccine is currently in very early-stage testing. The mRNA technology used in this vaccine has shown promise in the rapid development and deployment of COVID-19 vaccines, which were among the first to receive authorization from the Food and Drug Administration (FDA). This technology offers several advantages, including efficacy, speed of development, scalability, and reliability, as demonstrated during the COVID-19 pandemic.
The funding will also enable Moderna to enhance its vaccine response capability, including the use of large-scale commercial mRNA manufacturing and ongoing seasonal flu vaccine development. HHS has secured a fair pricing agreement to ensure cost savings and access to vaccines. Moderna will prepare materials and conduct clinical trials to collect safety and immune response data to support FDA approval and potentially scale up production in a public health emergency.
The award also allows for the rapid development of mRNA vaccines targeted at various influenza virus subtypes or strains with pandemic potential. This flexibility is essential in addressing other emerging infectious diseases as they arise. If successfully developed, Moderna’s mRNA-based pandemic flu vaccine could significantly improve response times if a new virus strain emerges.
In 2023, BARDA requested proposals from Moderna and other companies to develop mRNA vaccines for potential public health emergencies caused by influenza viruses, including H5N1. Moderna has initiated a study to evaluate the safety and immunogenicity of its pandemic influenza vaccine in people aged 18 and older. This study includes vaccine candidates against H5 and H7 bird flu viruses, with results expected in 2024 to inform further development plans.
In the U.S., there have been four human cases of bird flu, including three in 2024. Health officials maintain that the risk to the general population remains low, although dairy workers and others working near infected cows face a heightened risk. Beyond the announcement for Moderna, federal health officials have already begun emergency preparedness against bird flu.
The Administration for Strategic Preparedness and Response (ASPR), within HHS, has 4.8 million doses of bird flu vaccine being prepared for potential use pending FDA approval. These doses could be ready by mid-July through August. However, vaccines may not be the only solution to address bird flu should the outbreak spread further into humans. Other options, such as the widespread use of antivirals, may be considered to contain the virus.
Moderna’s CEO, Stephane Bancel, highlighted the advantages of mRNA vaccine technology, including its efficacy, speed of development, and scalability. Manufacturing conventional flu vaccines using cell or egg-based technology can take four to six months, whereas mRNA technology offers a more rapid response.
U.S. officials have stated that they are moving bulk vaccine from CSL Seqirus that closely matches the current virus into finished shots that could provide 4.8 million doses if needed. These doses would potentially be used to inoculate farm workers and others at risk of exposure to the virus. For the general public, U.S. and global health officials continue to assert that the risk from bird flu remains low.
Source: Associated Press, Bloomberg
