Public Health Vaccines wins BioMaP contract to move Marburg vaccine manufacturing to the U.S.

Public Health Vaccines has won a BioMaP-Consortium contract to transfer production and testing of its PHV01 Marburg vaccine candidate from offshore sites to U.S. manufacturing facilities. The move is aimed at strengthening domestic live viral vaccine capacity and preparing for faster scale-up if outbreaks or other infectious threats emerge.

Why it matters: - Domestic capacity for live viral vector vaccines remains limited, especially for vaccines used against viral hemorrhagic fevers. - Moving PHV01 manufacturing to U.S. facilities is intended to strengthen vaccine supply chain resilience and improve outbreak response readiness. - Marburg virus disease has no licensed vaccine today and can be severe, with a reported fatality ratio of up to 88%. - The U.S. Department of Homeland Security has determined Marburg virus to be a material threat to national security.

What happened: - Public Health Vaccines, LLC won a contract from the Biopharmaceutical Manufacturing Preparedness Consortium to tech transfer production and testing of PHV01, its monovalent VSV ΔG Marburg Angola vaccine candidate, to the United States. - The project will move the complete manufacturing process from offshore facilities to Ascend-ABL’s U.S.-based CGMP sites in Maryland and Florida. - The award is worth about $11 million. - The contract is funded in whole or in part with federal funds from the Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority under OT number #75A50123D00003.

The details: - PHV01 uses a recombinant vesicular stomatitis virus, or rVSV, vector platform originally developed by the Public Health Agency of Canada. - The transfer covers both BDS, or upstream and downstream production, and FDP, or formulation, fill and finish. - The U.S. manufacturing shift is meant to establish readiness for Phase 2-scale production and provide a base for rapid scale-up during emergencies. - Public Health Vaccines has been developing PHV01 with BARDA since February 2019 under contract #HHSO100201900022C. - PHV says the vaccine candidate has already completed Phase 1 clinical testing and is expected to enter Phase 2 clinical testing in the coming months. - The BioMaP-Consortium brings together pharmaceutical, medical, academic and scientific organizations focused on medical countermeasure development and delivery. - PHV’s portfolio also includes vaccines for Marburg virus, Sudan ebolavirus, Ebola Bundibugyo and Nipah virus. - BARDA has funded PHV’s Marburg, Sudan ebolavirus and Ebola Bundibugyo programs, while the Coalition for Epidemic Preparedness Innovations has funded its Nipah and Ebola Bundibugyo programs.

Between the lines: - The award signals continued U.S. government interest in rebuilding domestic manufacturing for high-consequence biologics, not just advancing one vaccine candidate. - PHV is positioning its rVSV platform as a repeatable manufacturing system for filovirus vaccines, which could matter if future outbreaks require faster deployment. - A successful transfer could reduce dependence on offshore production for a category of vaccines that is hard to make and strategically important.

What's next: - PHV will complete the technology transfer of PHV01 manufacturing and testing to Ascend-ABL’s U.S. sites. - The company expects to begin Phase 2 clinical testing in the coming months. - The manufacturing base created by the project is intended to support emergency scale-up if demand rises.

The bottom line: - PHV’s new contract moves a Marburg vaccine candidate closer to U.S.-based production and adds capacity in a vaccine area with no licensed product and high national security relevance.