GeoVax's Mpox Vaccine Gets EMA Green Light for Streamlined Approval Path

GeoVax Labs, Inc., a clinical-stage biotechnology company, has received positive Scientific Advice from the European Medicines Agency (EMA) for its GEO-MVA vaccine, aimed at preventing Mpox and smallpox. This guidance confirms that a single Phase 3 immuno-bridging trial could suffice for evaluating efficacy and supporting a Marketing Authorization Application (MAA), potentially accelerating the regulatory approval process. The EMA's feedback aligns with GeoVax's development strategy, eliminating the need for multiple development steps typically required for vaccines. This development is timely, as the World Health Organization has 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 highly virulent Mpox strains. The company is also progressing towards next-generation manufacturing capabilities to ensure scalable and cost-effective production.

The EMA's agreement with GeoVax's proposed strategy comes at a critical time when public health authorities are under pressure to diversify vaccine supplies due to escalating Mpox transmission and strained global stockpiles. GeoVax's GEO-MVA vaccine not only addresses immediate needs by expanding vaccine availability but also plans to shift to a more scalable production method, aiming for self-sufficiency in regions like Africa. This initiative represents a significant step towards meeting global and domestic needs for Mpox and smallpox preparedness, offering a critical alternative to current vaccine solutions. For more information on GeoVax's developments, visit www.geovax.com.