GeoVax Advances U.S.-Based Mpox Vaccine Production Following California Clade 1 Outbreak

The confirmation of locally transmitted Clade 1 mpox cases in Los Angeles County represents a significant escalation in the public health threat facing the United States, according to clinical-stage biotechnology company GeoVax Labs. Three individuals were recently hospitalized with the more severe Clade 1 strain despite having no history of international travel, marking the first known local spread of this dangerous variant in the country. The California Department of Public Health confirmed these cases through their official reporting system (http://www.publichealth.lacounty.gov/phcommon/public/media/mediapubhpdetail.cfm?prid=5161).

This development exposes critical vulnerabilities in America's vaccine supply chain, as the nation remains dependent on a single foreign manufacturer for the currently approved MVA-based mpox vaccine. David Dodd, Chairman & CEO of GeoVax, emphasized the strategic risk of this arrangement, stating that relying on a single overseas manufacturer for such a critical biosecurity countermeasure is unwise and unsustainable. The emergence of locally spread Clade 1 mpox in California serves as a warning sign that America needs a diversified vaccine arsenal including U.S.-based manufacturing and scalable platforms designed for both epidemic response and national stockpiling.

GeoVax's response includes advancing their GEO-MVA vaccine, which has received favorable Scientific Advice from the European Medicines Agency confirming a streamlined path directly to a Phase 3 immuno-bridging trial. This regulatory endorsement accelerates GEO-MVA's trajectory toward potential market authorization and strengthens its prospective role as a critical additional source MVA vaccine. The company is simultaneously developing a next-generation continuous avian cell line manufacturing platform designed to replace traditional egg-based vaccine production, enabling rapid, high-volume U.S.-based production that reduces costs and shortens deployment timelines.

These initiatives align with multiple federal pandemic preparedness actions, including a White House Executive Order directing FDA and other agencies to accelerate domestic capacity and reduce foreign dependency. The HHS-ASPR-DARPA EQUIP-A-Pharma Initiative is advancing AI-driven, modular U.S.-based manufacturing platforms for critical medicines, while Congressional bipartisan action led by Senators Joni Ernst and Lisa Blunt Rochester seeks to onshore critical medical manufacturing. The National Security Commission on Emerging Biotechnology has also recommended a $15 billion investment in U.S.-owned biotech infrastructure.

The urgency of these developments stems from the escalating nature of mpox outbreaks across Africa, Europe, and now the United States. Clade 1 mpox is associated with more severe illness than the Clade 2 strain that has circulated in the U.S. since 2022, making the current supply chain fragility particularly concerning during a period of increasing case numbers. GeoVax's combination of clinically validated MVA platform technology, EMA-endorsed expedited development plan, and continuous cell line manufacturing strategy positions the company to address these critical national security and public health challenges through domestic production capabilities that can respond rapidly to emerging threats.