Moderna MRNA announced that the U.S. government, through the Biomedical Advanced Research and Development Authority (“BARDA”), has awarded the company $590 million to accelerate the development of an mRNA-based vaccine program aimed at preventing the spread of the H5N1 virus, also known as bird flu, in humans.
Moderna intends to use the above-mentioned funds to support the late-stage development of mRNA-1018, its investigational pandemic influenza vaccine against H5 and H7 avian influenza viruses. Per management, the funding will also help fund the expansion of clinical studies for up to five additional pandemic influenza subtypes.
The company started a phase I/II study on mRNA-1018 in 2023 in healthy adults. Based on positive preliminary data from this study, it is advancing the vaccine to late-stage development. Management also intends to share data from the phase I/II study at a future medical meeting.
This is the second time under a year that Moderna has secured funding from the U.S. government for its bird flu vaccine. Last July, the company was awarded $176 million by the U.S. government to expedite the development of this vaccine.
Earlier this month, the U.S. Centers for Disease Control and Prevention (“CDC”) confirmed the first human death in the country from the H5N1 virus. Though the agency believes that the risk to the general public remains low due to a lack of evidence of human-to-human transmission, it continues to monitor for H5N1 activity, especially in people exposed to animals. As of Jan. 17, the CDC confirmed 67 human cases of H5N1 virus in the country since the beginning of last year.
Post the announcement, shares of Moderna were up nearly 5% in after-market trading on Friday. Some investors pointed out that this latest news could help bolster Moderna's financial performance, which faced a major setback last week after management slashed its 2025 revenue guidance.
Unlike traditional vaccines, which can take months to produce, mRNA-based vaccines can be developed quickly and offer manufacturing scalability, something that was observed in the case of COVID-19 vaccines. BARDA believes this to be a major advantage for mRNA vaccines, especially in case new strains/variants of the virus emerge.
The stock has plunged nearly 66% in the past year compared with the industry’s 14.1% decline.
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Moderna is not the only company to reach an agreement with BARDA for bird flu vaccines. BARDA also has a deal in place for 150 million doses of CSL Seqirus’ protein-based H5N1 bird flu vaccine. In October, CSL received its sixth avian influenza pandemic preparedness award worth $34 million from BARDA.
Another company that is developing its bird flu vaccine is CureVac CVAC. Last year, CVAC announced that it has started a phase I/II study on its bird flu vaccine. CureVac is developing this investigational mRNA-based vaccine in collaboration with GSK.
Novavax NVAX is also developing a bird flu vaccine in preclinical studies. NVAX claimed that this vaccine uses a new approach to immunize against the virus.
Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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