New Recombinant Mpox Strain Highlights Global Vaccine Supply Vulnerabilities as GeoVax Advances Alternative

The confirmation of a newly evolved recombinant Mpox strain by UK health authorities has brought renewed attention to the ongoing evolution of the pathogen and the strategic vulnerabilities in global vaccine supply. Early analysis indicates this variant contains genetic elements from both Clade I and Clade II Mpox viruses, which could have implications for disease severity, transmissibility, and vaccine effectiveness. This discovery occurs while the world's Mpox vaccine supply remains concentrated with a single manufacturer, creating significant risks for preparedness, surge capacity, and equitable global access.

GeoVax Labs, Inc. is addressing this critical gap through its accelerated GEO-MVA program. The company is developing what it aims to be the first U.S.-manufactured Mpox and smallpox vaccine, designed to reduce reliance on foreign suppliers and support national biodefense priorities. David Dodd, Chairman & CEO of GeoVax, stated that the emergence of the recombinant strain serves as a reminder that viral evolution continues, and dependence on a single global vaccine provider creates clear risks to preparedness, national security, and market stability.

Significant regulatory momentum is supporting GeoVax's efforts. The company recently received positive Scientific Advice from the European Medicines Agency confirming that it may proceed directly to a single Phase 3 immuno-bridging trial for GEO-MVA, bypassing Phase 1 and Phase 2 trials to support a Marketing Authorization Application. This guidance from the EMA's Committee for Medicinal Products for Human Use provides a substantial acceleration of the regulatory timeline, a de-risked development path, and potentially earlier commercialization across all 27 EU member states.

The GEO-MVA vaccine is engineered as a Modified Vaccinia Ankara-based vaccine with dual-use capability for both public health needs and Strategic National Stockpile requirements. Key attributes include robust multi-antigen immunity designed to support strong humoral and T-cell responses, along with scalable modern production methods. GeoVax's planned transition to AGE1 continuous cell-line manufacturing is expected to expand output, reduce costs, and support global self-sufficiency in vaccine production.

From a manufacturing perspective, final fill-finish activities for GEO-MVA are scheduled for completion by year-end, with first-in-human studies planned upon regulatory clearance. The company's progress represents a strategic response to what public health experts identify as a dangerously concentrated global supply model that heightens vulnerability for stockpile readiness and equitable vaccine distribution. As the Mpox virus continues to evolve with simultaneous circulation of multiple clades creating ongoing risk for recombination, the development of diversified vaccine manufacturing capacity takes on increased importance for global health security. For more information about the company's developments, visit https://www.geovax.com.