GeoVax Urges Multisource Mpox Vaccine Strategy Following California Clade 1 Outbreak

The confirmation of locally transmitted Clade 1 mpox cases in Los Angeles County, California has exposed significant vulnerabilities in America's vaccine supply chain and prompted urgent calls for diversified manufacturing capabilities. Three individuals were recently hospitalized with the more severe Clade 1 strain despite having no international travel history, marking the first known local spread of this dangerous variant 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 critical need for second-source vaccine solutions at a time when outbreaks are escalating across Africa, Europe, and now domestically.

The United States currently relies on a single foreign manufacturer for the approved MVA-based mpox vaccine, creating significant vulnerabilities in cost, supply chain security, and surge capacity. David Dodd, Chairman & CEO of GeoVax, emphasized the strategic risk of this dependency, stating that relying on a single overseas manufacturer for critical biosecurity countermeasures is both unwise and unsustainable. The emergence of locally spread Clade 1 mpox in California serves as a stark warning 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 GEO-MVA vaccine 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 the vaccine'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 the immediate public health threat posed by the more severe Clade 1 strain, which is associated with more serious illness than the Clade 2 variant that has circulated in the U.S. since 2022.

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 would reduce costs, shorten deployment timelines, and reinforce national security. The company's efforts align directly with multiple federal initiatives aimed at modernizing America's pandemic response capabilities, including White House Executive Orders on pharmaceutical independence, the HHS-ASPR-DARPA EQUIP-A-Pharma Initiative advancing AI-driven manufacturing platforms, and Congressional bipartisan action championed by Senators Joni Ernst and Lisa Blunt Rochester seeking to onshore critical medical manufacturing.

The National Security Commission on Emerging Biotechnology has recommended a $15 billion investment in U.S.-owned biotech infrastructure, reflecting growing recognition of the strategic importance of domestic vaccine manufacturing capacity. Dodd noted that these federal initiatives signal America's seriousness about pandemic readiness and supply chain security, with GeoVax positioned to answer that call through its clinically validated MVA platform, EMA-endorsed development plan, and continuous cell line manufacturing strategy. The convergence of emerging public health threats and advancing manufacturing technologies creates a pivotal moment for strengthening national biosecurity infrastructure against future pandemic risks.