GeoVax's GEO-MVA Vaccine Receives European Regulatory Backing, Paving Way for Faster Approval

The European Medicines Agency (EMA) has provided GeoVax Labs, Inc. with positive Scientific Advice for its GEO-MVA vaccine, a development that could significantly streamline the path to regulatory approval in Europe. This guidance confirms that a single Phase 3 immuno-bridging trial would suffice to evaluate the vaccine's efficacy against Mpox and smallpox, potentially eliminating the need for Phase 1 and Phase 2 trials. This regulatory milestone is particularly timely, given the World Health Organization's recent declaration of Mpox as a Public Health Emergency of International Concern, highlighting the urgent need for diversified vaccine options.

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 agreement not only accelerates the development timeline but also addresses the critical shortage of Mpox vaccines globally. GeoVax's Chairman and CEO, David Dodd, emphasized the importance of this development in enhancing global health resilience, especially in light of the ongoing spread of Mpox across multiple continents and the detection of the virus in wastewater in several U.S. states.

The strategic regulatory pathway outlined by the EMA could enable GeoVax to bring GEO-MVA to market more quickly, offering a much-needed alternative to the current single-supplier scenario for Mpox and smallpox vaccines. Furthermore, GeoVax's plans to transition to a next-generation manufacturing platform promise scalable and cost-effective production, aiming to ensure vaccine self-sufficiency in regions like Africa and the U.S. This development is a significant step forward in the global effort to combat Mpox and smallpox, providing hope for expanded vaccine availability and strengthened public health preparedness.