The U.S. Department of Health and Human Services (HHS) has announced the termination of its contract with pharmaceutical company Moderna for the late-stage development of a pre-pandemic influenza vaccine, specifically targeting the H5 avian flu virus. The move, dated May 28, 2025, comes as the agency undertakes a broader reevaluation of therapies utilizing messenger RNA (mRNA) technology.
The cancellation of the award for late-stage development and the government’s right to purchase the vaccines casts uncertainty on the future of Moderna’s mRNA-1018 avian flu vaccine program, despite the company concurrently announcing positive interim results from its Phase 1/2 clinical study.
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Moderna revealed that the early to mid-stage trial, involving approximately 300 healthy adults, demonstrated that its H5 avian flu vaccine candidate elicited a “rapid, potent and durable immune response.”
According to the interim data, 97.8% of participants achieved hemagglutination inhibition (HAI) antibody titers considered to correlate with protection three weeks after the second dose, a significant increase from the 2.1% at baseline. The company also stated the vaccine was generally well-tolerated.
Despite these clinical findings, HHS has decided to halt its funding for the program’s progression.
In a statement, HHS Communications Director Andrew Nixon said, “After a rigorous review, we concluded that continued investment in Moderna’s H5N1 mRNA vaccine was not scientifically or ethically justifiable. The reality is that mRNA technology remains under-tested, and we are not going to spend taxpayer dollars repeating the mistakes of the last administration, which concealed legitimate safety concerns from the public.” This decision aligns with a reported broader effort by the current administration to scrutinize spending on mRNA-based vaccines and ensure transparency.
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Moderna’s Chief Executive Officer, Stéphane Bancel, acknowledged the setback while emphasizing the positive trial data.
“While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase 1/2 study of our H5 avian flu vaccine and we will explore alternative paths forward for the program,” Bancel stated. He further added, “These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats.”
The company has affirmed its commitment to pandemic preparedness and will now explore alternative avenues for the late-stage development and manufacturing of its H5 avian flu vaccine program.
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