GeoVax Advances Toward European Approval for Mpox and Smallpox Vaccine

GeoVax Labs, Inc., a clinical-stage biotechnology company, has achieved a significant milestone in the development of its GEO-MVA vaccine for Mpox and smallpox. The European Medicines Agency (EMA) has provided favorable Scientific Advice, confirming that a single Phase 3 immuno-bridging trial could suffice for evaluating the vaccine's efficacy and supporting a Marketing Authorization Application (MAA). This guidance eliminates the need for multiple development steps, potentially accelerating the regulatory approval process.

The EMA's Committee for Medicinal Products for Human Use (CHMP) agreed with GeoVax's proposed non-clinical studies and immunogenicity endpoints, which are designed to demonstrate the vaccine's non-inferiority to the currently approved MVA vaccine, Imvanex. This development is particularly timely, as the World Health Organization has recently declared Mpox a Public Health Emergency of International Concern, highlighting the need for expanded vaccine availability.

David Dodd, Chairman and CEO of GeoVax, emphasized the importance of diversifying vaccine supply to strengthen global health resilience. The company's progress with GEO-MVA, including plans to transition to a next-generation manufacturing platform, represents a critical step toward meeting both immediate and long-term needs for Mpox and smallpox preparedness. This advancement comes at a crucial time, with the emergence of highly virulent strains of the virus and detection in multiple regions underscoring the urgency for new vaccine options.