GeoVax Receives EMA Guidance for Streamlined Development of Mpox and Smallpox Vaccine

GeoVax Labs, Inc., a clinical-stage biotechnology company, has announced a significant regulatory advancement for its GEO-MVA vaccine, aimed at preventing Mpox and smallpox. The European Medicines Agency (EMA) provided positive Scientific Advice, endorsing a streamlined development pathway that could lead to faster approval. This guidance confirms that a single Phase 3 immuno-bridging trial would suffice to evaluate the vaccine's efficacy and support a Marketing Authorization Application (MAA), eliminating the need for Phase 1 and Phase 2 trials.

The EMA's Committee for Medicinal Products for Human Use (CHMP) agreed with GeoVax's proposed immunogenicity endpoints and non-clinical studies, marking a pivotal step towards regulatory approval in Europe. This development is timely, as the World Health Organization recently declared Mpox a Public Health Emergency of International Concern, highlighting the urgent need for expanded vaccine availability. GeoVax's CEO, David Dodd, emphasized the importance of diversifying vaccine supply to strengthen global health resilience, especially with the emergence of more virulent Mpox strains.

The EMA's guidance not only accelerates the potential approval of GEO-MVA but also underscores the critical need for additional vaccine manufacturers to address the global demand. GeoVax is committed to enhancing vaccine accessibility and manufacturing resilience, with plans to transition to a next-generation production platform for scalable and cost-effective vaccine supply. This regulatory milestone represents a significant leap forward in the global fight against Mpox and smallpox, offering hope for a more robust public health response to these infectious diseases.