Moderna's Bird Flu Vaccine Funding Nixed Is Pandemic Prep in Peril?

HHS Pulls Funding for Moderna's H5 Avian Flu Vaccine: A Step Back in Pandemic Preparedness?

In a move that has sparked considerable debate and concern within the public health community, the U.S. Department of Health and Human Services (HHS) has terminated a $590 million award previously granted to Moderna for the late-stage development of its mRNA vaccine candidate against H5 avian influenza, as well as other prepandemic vaccine initiatives. The announcement, made by Moderna yesterday, has raised questions about the nation's readiness for a potential avian flu pandemic.

The funding, initially awarded in January, was intended to bolster the development of vaccines targeting potential pandemic flu viruses. This decision comes even as Moderna released positive interim phase 1/2 clinical data for its H5 avian influenza vaccine candidate.

A Timeline of the Funding and its Cancellation:

• July 2024: Moderna receives a $176 million base award from HHS amid rising H5N1 infections in US residents, particularly agricultural workers.
• January 17: In the final days of the Biden administration, HHS announces a $590 million contract to fund the development of vaccines against potential pandemic flu viruses.
• Early March: Following the transition to the Trump administration, HHS signals that it is evaluating the contract.
• Present: HHS terminates the $590 million award.

This decision arrives against the backdrop of continued circulation of H5N1 in various animal populations across the United States and globally. These include:

• US dairy cattle
• Poultry flocks
• Wild birds
• Other mammals
• Animal outbreaks in other countries
• Sporadic H5N1 infections in some Asian countries, like Cambodia and Vietnam

Concerns from Public Health Experts

The cancellation has been met with strong criticism from public health experts. Ashish Jha, MD, MPH, dean of the Brown University School of Public Health, voiced his concerns on X, stating that the decision "puts American lives at risk." He further criticized the "attack on mRNA vaccines," emphasizing their proven safety and effectiveness.

Krutika Kuppalli, MD, with the University of Texas Southwestern Medical Center, described the move as "stunningly shortsighted" on BlueSky, particularly given the rising H5N1 threats and recent fatal cases. She warned, "This will come back to bite us. Hard."

Promising Clinical Trial Data

Despite the funding setback, Moderna's announcement included positive interim results from a phase 1/2 clinical trial. The study, involving 300 healthy adults, evaluated a 2-dose regimen. Key findings include:

• Minimal pre-existing immunity at baseline (2.1% of participants showing hemagglutinin titers at a level considered to correlate with protection).
• At day 43 (3 weeks after the second dose), 97.9% of participants had a 44.5-fold increase in titers from baseline.
• The data suggests a rapid, potent, and durable immune response.

Moderna's Response

Stéphane Bancel, MBA, MS, Moderna’s chief executive officer, acknowledged the uncertainty caused by the HHS decision but expressed satisfaction with the observed immune response and safety profile of the vaccine. He stated, "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."

The HHS's decision to withdraw funding from Moderna’s H5 avian flu vaccine program raises critical questions about the future of pandemic preparedness and the role of mRNA technology in combating emerging infectious diseases. While the reasons behind the decision remain a subject of speculation, the potential consequences for public health are a serious concern. As Moderna explores alternative pathways for development, the world watches, hoping that this setback will not derail the progress made in preparing for a potential avian flu pandemic.

Tags: Moderna, H5N1, Avian flu, HHS, Vaccine, Pandemic, mRNA vaccine, US Health, Trump administration, Biden administration

Source: https://www.cidrap.umn.edu/avian-influenza-bird-flu/hhs-cancels-funding-moderna-s-candidate-h5-avian-flu-and-pandemic-vaccines