The global health community faces a growing challenge as Mpox outbreaks, caused by both Clade I and Clade II strains, expand across continents. GeoVax Labs, Inc. has highlighted the critical need for diversified vaccine supplies, especially with the recent Scientific Advice from the European Medicines Agency (EMA) supporting an expedited development pathway for its GEO-MVA vaccine candidate. This development comes at a time when the Airfinity July 2025 Mpox Report underscores the silent spread of Clade I Mpox in China, Europe, and the United States, alongside travel-linked cases from Ethiopia and the Democratic Republic of the Congo (DRC).

The EMA’s endorsement of a single Phase 3 immuno-bridging trial for GEO-MVA represents a significant step forward in addressing the urgent need for Mpox vaccines. This approach allows for vaccine approval based on comparable immune responses, reducing development time without compromising regulatory standards. GeoVax’s Chairman and CEO, David Dodd, emphasized the strategic and urgent need for second-source MVA-based vaccines, given the increasing number of breakthrough infections and pregnancy-related complications linked to Mpox.

The global spread of Clade I Mpox, with new detections in populous regions like China and travel-linked cases in G7 countries, underscores the importance of vaccine diversification. The DRC’s confirmation of vertical Mpox transmission further highlights the need for next-generation vaccines with broader safety data. GeoVax’s GEO-MVA vaccine candidate, with its potential for scalable, lower-cost production and U.S.-based manufacturing, is positioned as a viable alternative to current MVA vaccine supplies.

GeoVax is actively engaging with global stakeholders, including the World Health Organization (WHO) and Africa CDC, to explore advance purchase agreements and manufacturing alliances. These efforts aim to ensure rapid deployment of GEO-MVA in current and emerging hotspots, addressing the immediate and long-term challenges posed by the global Mpox situation.

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