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 has exposed critical vulnerabilities in America's vaccine supply chain, prompting GeoVax Labs to emphasize the urgent need for multisource vaccine solutions. Three individuals were recently hospitalized with Clade 1 mpox in Los Angeles County despite having no international travel history, representing the first known local spread of this more severe strain in the United States according to public health authorities (http://www.publichealth.lacounty.gov/phcommon/public/media/mediapubhpdetail.cfm?prid=5161).

This development underscores the fragility of global vaccine supply chains, as the United States remains dependent on a single foreign manufacturer for the currently approved MVA-based mpox vaccine. David Dodd, Chairman & CEO of GeoVax, stated that relying on a single overseas manufacturer for critical biosecurity countermeasures is unsustainable, particularly as outbreaks escalate across Africa, Europe, and now the United States. The emergence of locally spread Clade 1 mpox in California serves as a warning sign that America needs diversified vaccine arsenals including U.S.-based manufacturing and scalable platforms designed for both epidemic response and national stockpiling.

GeoVax's response includes advancing its GEO-MVA vaccine, which has received favorable Scientific Advice from the European Medicines Agency confirming a streamlined path directly to Phase 3 immuno-bridging trials. This regulatory guidance accelerates GEO-MVA's trajectory toward potential market authorization and strengthens its prospective role as a critical additional source MVA vaccine. The expedited development pathway represents a significant advancement in addressing immediate public health threats while maintaining rigorous safety and efficacy standards.

Concurrently, GeoVax is advancing a next-generation continuous avian cell line manufacturing platform designed to replace traditional egg-based vaccine production. This innovation is anticipated to enable rapid, high-volume U.S.-based production that reduces costs, shortens deployment timelines, and reinforces national security. The transition to continuous cell line manufacturing addresses longstanding challenges in vaccine production scalability and reliability during public health emergencies.

These initiatives align with multiple federal pandemic preparedness actions, including White House Executive Orders 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 seeks to onshore critical medical manufacturing. National Security Commission on Emerging Biotechnology recommendations have called for substantial investments in U.S.-owned biotech infrastructure to strengthen national biosecurity.

The convergence of emerging public health threats and federal preparedness initiatives creates a pivotal moment for vaccine innovation and manufacturing independence. GeoVax's combination of clinically validated MVA platforms, EMA-endorsed development plans, and continuous cell line manufacturing strategy positions the company to contribute significantly to national biosecurity while addressing immediate global health challenges posed by mpox variants.