US gives Moderna $176 million to develop mRNA pandemic flu vaccine
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Key takeaways:
- Moderna is conducting a phase 1/2 trial of candidate vaccines against bird flu.
- Bird flu has affected millions of birds and dairy cattle since 2022, but only four human cases have been confirmed.
HHS announced that it will give Moderna around $176 million to accelerate the development of a messenger RNA-based pandemic influenza vaccine amid an ongoing outbreak of avian influenza.
The funds were awarded by HHS through the Biomedical Advanced Research and Development Authority (BARDA) and its Rapid Response Partnership Vehicle Consortium, a 10-year effort to support the research and development of vaccines, therapeutics and diagnostics as medical countermeasures, according to an HHS press release.
“The award ... is part of our longstanding commitment to strengthen our preparedness for pandemic influenza,” Dawn O’ Connell, HHS assistant secretary for preparedness and response, said in the release. “Adding this technology to our pandemic flu toolkit enhances our ability to be nimble and quick against the circulating strains and their potential variants.”
According to the CDC, highly pathogenic avian influenza A(H5N1) — also called bird flu — has affected more than 97 million wild birds, commercial poultry and backyard flocks across all 50 states. Bird flu also has affected 136 dairy cow herds in 12 states, with 56 confirmed cases in the last 30 days, the USDA reported.
There have also been three confirmed human cases of H5N1 in 2024, all in dairy workers with presumed exposure to infected cattle. The CDC still considers the risk to the general public to be low.
In 2023, BARDA issued a request for proposal to Moderna and other companies for development of mRNA vaccines for potential public health emergencies related to influenza viruses, including bird flu. These types of vaccines can complement traditional technologies during a pandemic emergency response.
Moderna in 2023 launched a phase 1/2 trial to study the safety and immunogenicity of its mRNA-1018 pandemic influenza vaccine candidate in 1,500 healthy adults. Results from the study, which is set to conclude this year, will inform phase 3 development plans, the company said in a press release. Vaccine candidates against both H5 and H7 avian influenza viruses are included in the study.
The HHS funds will support late-stage development of an mRNA-based vaccine to enable licensure of a pre-pandemic vaccine for H5 influenza virus, as well as options to prepare and accelerate a response to potential public health emergencies. The award will also allow development and manufacturing to quickly pivot in the face of other public health threats, such as emerging infectious diseases, according to HHS.
Moderna also recently announced positive findings from a phase 1/2 trial of its mRNA combination vaccine for influenza and COVID-19.
“We have successfully taken lessons learned during the COVID-19 pandemic and used them to better prepare for future public health crises,” HHS Secretary Xavier Becerra, said in the release. “As part of that, we continue to develop new vaccines and other tools to help address influenza and bolster our pandemic response capabilities. Importantly, we are doing this work in partnership with some of the nation’s leading scientists and clinicians.”
References:
- A study of m-RNA-1018 pandemic influenza candidate vaccines in healthy adults. https://clinicaltrials.gov/study/NCT05972174. Updated January 31, 2024. Accessed July 2, 2024.
- H5N1 bird flu: Current situation. https://www.cdc.gov/bird-flu/situation-summary/index.html. Updated July 1, 2024. Accessed July 2, 2024.
- Moderna receives project award through BARDA’s rapid response partnership vehicle consortium to accelerate development of mRNA-based pandemic influenza vaccine. https://investors.modernatx.com/news/news-details/2024/Moderna-Receives-Project-Award-through-BARDAs-Rapid-Response-Partnership-Vehicle-Consortium-to-Accelerate-Development-of-mRNA-based-Pandemic-Influenza-Vaccine/default.aspx. Published July 2, 2024. Accessed July 2, 2024.
- USDA. HPAI confirmed cases in livestock. https://www.aphis.usda.gov/livestock-poultry-disease/avian/avian-influenza/hpai-detections/hpai-confirmed-cases-livestock. Updated July 2, 2024. Accessed July 2, 2024.
Perspective
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Avian influenza is a perpetual pandemic threat that can be proactively planned for with advance medical countermeasure development. The announcement of the Moderna-BARDA contract reflects proactivity, as the government is seeking to diversify the types of avian influenza vaccines in its stockpile.
Moderna’s mRNA vaccine technology, which has been highly successful with COVID-19, will be important for any future avian influenza pandemic. The company also has made strides with vaccines for RSV and seasonal influenza. Messenger RNA technology is a strong and rapid force humans can wield to enhance their resiliency against infectious disease threats.
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