GeoVax Responds to New Mpox Variant, Highlights Vaccine Supply Concerns and Accelerated Development Program

The identification of a newly evolved recombinant Mpox strain by UK health authorities underscores the ongoing evolution of the pathogen and highlights significant vulnerabilities in global vaccine preparedness. Early analysis indicates this variant contains genetic elements from both Clade I and Clade II Mpox viruses, raising concerns about potential changes in disease severity and transmissibility. This discovery occurs within a context where global Mpox vaccine supply remains concentrated with a single manufacturer, creating substantial risks for stockpile readiness, surge capacity, and equitable geopolitical access.

GeoVax Labs, Inc. is advancing its GEO-MVA program as a strategic response to these challenges, aiming to establish the first U.S.-based Mpox and smallpox vaccine. The company's initiative seeks to deliver a scalable, domestically manufactured solution that supports national biodefense priorities and contributes to global supply diversification. Final fill-finish manufacturing activities for GEO-MVA are scheduled for completion by year-end, with first-in-human studies planned pending regulatory clearance.

David Dodd, Chairman and CEO of GeoVax, emphasized the timeliness of this development, stating that viral evolution continues unabated. He noted the clear risks to preparedness, national security, and market stability posed by dependence on a single global vaccine provider. The company's development of GEO-MVA is positioned to address this strategic need by creating a U.S.-manufactured vaccine capable of supporting both domestic requirements and international demand.

Significant regulatory momentum has accelerated the GEO-MVA development pathway. GeoVax recently received positive Scientific Advice from the European Medicines Agency (EMA), confirming the company may proceed directly to a single Phase 3 immuno-bridging trial without requiring Phase 1 or Phase 2 studies to support a Marketing Authorization Application. The EMA's Committee for Medicinal Products for Human Use also affirmed the adequacy of GeoVax's proposed nonclinical package and agreed with the immunogenicity endpoints for demonstrating non-inferiority to licensed comparator vaccines.

This regulatory guidance provides a substantial acceleration of the development timeline, a de-risked path forward, and potentially earlier commercialization opportunities across all 27 European Union member states. The EMA's streamlined approach positions GeoVax for expedited approval, reduced development costs, and earlier revenue generation as the company advances toward Phase 3 trials. For more information about the company's clinical programs, visit https://www.geovax.com.

The emergence of this recombinant Mpox variant serves as a critical reminder of the continuous threat posed by viral evolution and the fragility of concentrated global vaccine supply chains. GeoVax's accelerated GEO-MVA program represents a concerted effort to enhance vaccine resilience through domestic manufacturing capabilities and regulatory-efficient development pathways. This approach addresses both immediate public health concerns and longer-term strategic biodefense requirements in an increasingly uncertain global health landscape.