GeoVax Advances Mpox Vaccine Development Amid Global Outbreaks

The global health landscape faces a growing challenge as Mpox outbreaks, particularly those caused by Clade I and Clade II strains, continue to expand across continents. GeoVax Labs, Inc., a clinical-stage biotechnology company, has highlighted the critical need for a diversified supply of Mpox vaccines. The European Medicines Agency (EMA) has supported GeoVax's proposed expedited development pathway for its GEO-MVA vaccine candidate, suggesting that a single Phase 3 immuno-bridging trial could suffice for Marketing Authorisation Application (MAA) approval. This approach significantly reduces development time while ensuring regulatory compliance.

Recent data from the Airfinity July 2025 Mpox Report underscores the severity of the situation, with Clade I Mpox cases now detected in China, the United Kingdom, Italy, and the U.S. The report also highlights the risk of vertical transmission of the virus, emphasizing the need for vaccines with comprehensive safety profiles. GeoVax's GEO-MVA vaccine candidate emerges as a scalable and strategic alternative, with plans to transition to a modernized manufacturing system for lower-cost, U.S.-based production.

David Dodd, Chairman and CEO of GeoVax, emphasized the urgency of expanding global Mpox vaccine access, citing the increasing number of breakthrough infections and pregnancy-related complications. The company is actively engaging with global health organizations and governments to facilitate rapid deployment of GEO-MVA in affected regions. This development represents a pivotal step towards enhancing the world's preparedness and response to Mpox outbreaks, offering hope for more resilient vaccine infrastructure.