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Moderna Secures $590M HHS Award to Advance mRNA-Based Pandemic Flu Vaccines

• Moderna has received a $590 million award from the U.S. Department of Health and Human Services to accelerate development of mRNA-based pandemic influenza vaccines.

• The company has initiated Phase 1/2 trials for mRNA-1018, targeting H5 and H7 avian influenza strains, with plans to advance to Phase 3 based on preliminary data.

• The funding, provided through BARDA's Rapid Response Partnership Vehicle Consortium, will support late-stage development and expand clinical studies for up to five additional pandemic flu subtypes.

Moderna Inc. has secured substantial federal support to advance its pandemic influenza vaccine program, marking a significant step forward in preparedness against potential global health threats. The U.S. Department of Health and Human Services (HHS) has awarded the company $590 million to accelerate the development of mRNA-based pandemic influenza vaccines.
The funding, channeled through the Rapid Response Partnership Vehicle (RRPV) Consortium and the Biomedical Advanced Research and Development Authority (BARDA), aims to support late-stage development and licensure of pre-pandemic mRNA vaccines. This initiative represents a strategic investment in next-generation vaccine technology to combat emerging influenza threats.

Clinical Progress and Development Plans

Moderna has already made significant strides in its pandemic influenza program. In 2023, the company initiated a Phase 1/2 clinical trial evaluating mRNA-1018, an investigational pandemic influenza vaccine. The study focuses on safety and immunogenicity in healthy adults aged 18 and older, specifically targeting H5 and H7 avian influenza virus strains - subtypes with pandemic potential.
Based on encouraging preliminary data from this trial, Moderna is preparing to advance mRNA-1018 into Phase 3 studies. The company plans to present detailed Phase 1/2 results at an upcoming scientific meeting, providing crucial insights into the vaccine's performance and potential.

Expanded Scope and Strategic Focus

The HHS award will enable Moderna to broaden its pandemic preparedness efforts significantly. The agreement supports the expansion of clinical studies to include up to five additional subtypes of pandemic influenza, strengthening the comprehensive approach to addressing potential outbreak threats.
This development aligns with Moderna's broader strategic vision for 2025, which emphasizes a focused portfolio addressing respiratory viruses, rare diseases, oncology, and latent viruses. The pandemic influenza program represents a key component of the company's respiratory virus platform, building on their successful mRNA technology experience.

Public Health Implications

The substantial federal investment underscores the critical importance of developing rapid-response vaccine capabilities for pandemic preparedness. By leveraging mRNA technology, which proved instrumental during the COVID-19 pandemic, this initiative aims to enhance the nation's ability to respond swiftly to emerging influenza threats.
The collaboration between Moderna and HHS, through BARDA's support, exemplifies the ongoing commitment to strengthening public health infrastructure and ensuring readiness for future pandemic challenges. This partnership could potentially revolutionize the approach to pandemic influenza vaccine development, offering faster and more adaptable solutions for emerging viral threats.
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