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US Department of Health and Human Services Grants $590 Million to Accelerate H5N1 mRNA Vaccine Development
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Key Takeaways
- HHS allocated $590 million to Moderna for mRNA-based H5N1 vaccine development amid pandemic concerns.
- H5N1 primarily affects birds but can cause severe respiratory symptoms in humans, with 67 confirmed cases.
As H5N1 bird flu outbreaks impact all 50 states, concerns grow over its spread to humans.
The US Department of Health and Human Services (HHS) granted $590 million to Moderna to accelerate development of an mRNA-based vaccine as concern for a potential H5N1 pandemic in humans grows.1
H5N1 vaccine vial | Image Credit: © syhin_stas - stock.adobe.com
H5N1 is a highly pathogenic avian influenza virus that typically spreads among birds, cattle, and other wild animals. However, it can also be passed to humans from exposure to infected animals or animal carcasses, resulting in mild to severe respiratory symptoms and conjunctivitis.2
“Although H5N1 infections remain a low risk to the general public, they can cause severe disease and should be taken seriously,” said Stephanie Kurdach, infectious disease analyst at GlobalData, in a press release. “An mRNA H5N1 vaccine would be particularly beneficial in the event of a pandemic, as they can be manufactured much quicker than traditional vaccines.”3
The success of mRNA vaccines such as those for SARS-CoV-2 demonstrated their ability to elicit robust immune responses, as well as their potential for rapid development and adaptability. This has paved the way for their application in other infectious diseases, including H5N1. In one study, H5N1-targeting vaccines demonstrated significant efficacy and activated substantial neutralizing antibody concentrations in ferrets.4
The FDA has approved multiple vaccines in the past that target H5N1; however, these are not effective against strains found in the 2024 outbreak. According to GlobalData, there are 12 vaccines in active development in phase 1, 2, and 3 trials to protect against H5N1 including influenza A/H5N1 vaccine (GSK, CureVac), mRNA-1018 (Moderna; NCT05972174), and influenza H5 vaccine (Sanofi).3,5,6
As of January 2025, all 50 states have outbreaks in poultry, which include both commercial and non-commercial farms or backyard flocks. The CDC has also reported rising cases in cattle and dairy cows, affecting more than 900 dairy herds across 16 states, primarily in California, Colorado, Michigan, and Texas. H5N1 cases have been confirmed in pets and other wild animals, with concerns that it may eventually impact pig populations, as well.2,3
The CDC has reported a total of 67 confirmed reported human cases of H5N1; however, this number may not accurately reflect the actual number of cases due to lack of testing and public awareness. Although the virus typically resolves in a few days, individuals with preexisting conditions, older adults, and young children may experience worse symptoms and outcomes. Two cases of severe infection are of particular concern to health experts, who identified virus mutations in the patients that may make it easier for H5N1 viral particles to attach to upper respiratory pathways in human, potentially contributing to human transmission. One of these cases, a man from Louisiana, was fatal, but is the only reported H5N1-related mortality as of January 2025.7,8
“Avian flu variants have proven to be particularly unpredictable and dangerous to humans in the past. That is why this response has been a top priority for the Biden-Harris Administration and HHS,” said Xavier Becerra, secretary of the HHS, in a press release. “Accelerating the development of new vaccines will allow us to stay ahead and ensure that Americans have the tools they need to stay safe.”1
