HHS Ends Moderna’s $590M Bird Flu Vaccine Deal

Highlights

• HHS has terminated a $590 million contract with Moderna for late-stage bird flu vaccine development.
• Moderna's mRNA-1018 showed promising early trial results with a 97.8% protective antibody response rate.
• The cancellation follows political changes in HHS leadership, with Robert F. Kennedy, Jr. at the helm.
• Moderna faces added financial pressure, with R&D spending down 19% and plans to reduce overall costs by $1.7 billion.
• The company is exploring new avenues to continue its pandemic preparedness vaccine work.

Federal Termination Raises Questions Over Late-Stage Development Plans

The U.S. Department of Health and Human Services (HHS) has officially terminated a $590 million contract with Moderna, significantly impacting the company's plans for advancing its pandemic bird flu vaccine into late-phase trials. The abrupt decision casts uncertainty over the biotech's path forward for mRNA-1018, a vaccine that uses messenger RNA to encode hemagglutinin glycoproteins, key components in fighting influenza viruses.

The HHS originally expanded its contract with Moderna in January 2024, after the company had already received $176 million in funding the previous year to develop mRNA-based pandemic influenza vaccines. As stated in the original text, "The HHS expanded the agreement in January, providing $590 million to fund late-phase development." This funding was meant to support later-stage clinical research and potential pre-pandemic vaccine stockpiling.

Contract Termination and Political Shifts

Moderna disclosed the contract cancellation on Wednesday, May 28, noting that the agreement had included both late-stage development and the federal right to purchase doses of the vaccine. "Moderna revealed the HHS has terminated the award for late-stage development and right to purchase pre-pandemic influenza vaccines." The company is now examining alternative pathways for continuing development and manufacturing.

The decision comes just three months after HHS initiated a reevaluation of its contracts with major biotech firms. The timing aligns with the appointment of Robert F. Kennedy, Jr. as department chief, a controversial figure who has previously criticized mRNA vaccines. According to the report, "RFK Jr. called COVID-19 shots, which overwhelmingly use mRNA, ‘the deadliest vaccine ever made’ in 2021," and his nonprofit had actively opposed FDA approvals for such products.

Clinical Results Show Promise Despite Setback

Alongside news of the contract's termination, Moderna released interim results from its phase 1/2 clinical trial for mRNA-1018. The study involved 300 adult participants. Prior to vaccination, only 2.1% of participants had antibody levels above the protective threshold. However, three weeks after the second dose, 97.8% showed adequate antibody responses. As reported: "Three weeks after receiving the second of two doses, 97.8% of participants had antibody titers above the threshold."

The vaccine demonstrated a strong safety profile, with no significant tolerability concerns. Most adverse reactions were mild and fell into grade 1 or 2 classifications, with little difference observed between the first and second doses. Moderna intends to share additional clinical findings at an upcoming scientific meeting.

Financial Challenges Add to Pressure

The loss of government backing adds financial strain at a time when Moderna is already cutting costs. "Moderna reduced its R&D spending by 19% in the first quarter." In addition, the company is aiming to reduce overall operating expenses by up to $1.7 billion. Without federal support, Moderna will now need to rely on internal resources or alternative partnerships to proceed with its pandemic preparedness efforts, including further development of mRNA-1018.

The company emphasized its commitment to pandemic readiness, noting it is seeking funding and collaboration opportunities consistent with its long-term strategy: "The company said it is now seeking alternatives consistent with its ‘strategic commitment to pandemic preparedness.’"