The U.S. government is close to finalizing a significant agreement with Moderna to fund the late-stage trial of its mRNA bird flu vaccine, according to a report by the Financial Times. This move comes amidst rising concerns about the outbreak spreading to dairy cows and the potential for broader public health implications.
Moderna has confirmed ongoing discussions with the federal government to advance its bird flu vaccine candidate, mRNA-1018, although it has not yet confirmed the specifics of the funding arrangement. "Moderna can confirm we are in discussions with the U.S. Government on advancing our pandemic flu candidate, mRNA-1018. The Phase 1/2 dosing of mRNA-1018 is complete, with data expected soon," the company stated.
The anticipated funding, which could amount to several tens of millions of dollars, is expected to come from the Biomedical Advanced Research and Development Authority (BARDA). This support would not only fund the late-stage trial but also include a commitment to procure doses if the trials prove successful. Sources close to the discussions indicated that the formal agreement could be finalized as early as next month.
The U.S. Department of Health and Human Services (HHS) has not provided immediate comments on the report. Meanwhile, shares of Moderna have seen a significant rise, about 40% since April 1, following the second reported human case of bird flu in the United States. The company's stock saw a further 3% increase in premarket trading on Thursday, reaching $151.25.
Moderna's experimental vaccine is designed to protect against multiple strains of the bird flu virus, including the currently circulating H5N1 variant. With dosing in an early-to-mid stage study completed, the company is awaiting crucial data that could pave the way for broader use of the vaccine.
The United States maintains a stockpile of bird flu vaccines that match the strain currently in circulation, alongside antivirals for treating human infections. However, a major epidemic or pandemic would necessitate a substantial scaling up of these stocks. In addition to Moderna, the U.S. government is also in discussions with other major pharmaceutical companies like Pfizer and CSL Seqirus regarding potential mRNA vaccines.
Last week, U.S. officials confirmed another human infection since the virus was first detected in dairy cattle in late March. The Centers for Disease Control and Prevention (CDC) continues to monitor the situation closely, maintaining that the risk to public health remains low. Marc Lacey, global executive director for pandemics at CSL, emphasized the importance of preparedness efforts. "We are closely monitoring the situation because we are acutely aware of the threat that influenza virus strains like H5N1 can pose and take seriously our role in preparedness efforts alongside our government and public health partners," Lacey said.
CSL Seqirus announced that BARDA has selected it to deliver nearly 5 million doses of a prepandemic vaccine matched to the current strain of bird flu. This effort is part of a broader strategy to ensure readiness against potential outbreaks and to mitigate risks associated with the H5N1 virus.
The risk of human-to-human transmission of bird flu remains extremely low, with most cases occurring in livestock workers who are in close contact with infected poultry or cattle. Nevertheless, infections can be treated with antiviral drugs if symptoms are promptly addressed.
