GeoVax Labs, Inc. has endorsed an urgent call to action from World Health Organization officials warning that the mpox epidemic remains a significant global health threat despite declining attention in some regions. The company's statement aligns with concerns raised in a recent PLOS Medicine article co-authored by Rosamund Lewis, MD, WHO Head of the Poxviruses Programme, which emphasizes ongoing transmission, morbidity, and mortality particularly across Africa.
The article highlights that evolving viral clades, constrained vaccine supply, and persistent inequities in access to countermeasures continue to drive mpox transmission. Dr. Lewis reinforced these concerns in a recent public call to action, emphasizing that sustained political will, financing, and expanded vaccine availability remain essential to controlling mpox as a global health threat. GeoVax Chairman and CEO David Dodd stated, "The data are clear: mpox continues to circulate, evolve, and disproportionately impact vulnerable populations. A durable response requires sustained investment, diversified vaccine supply, and readiness that extends beyond reactive surge manufacturing."
GeoVax's GEO-MVA program, a Modified Vaccinia Ankara-based vaccine for prevention of mpox and smallpox, aims to address the structural vulnerabilities highlighted in the analysis, particularly the world's continued dependence on a single manufacturer for licensed MVA vaccine supply. The company has completed GEO-MVA clinical material, positioning the program for late-stage clinical execution and supply readiness. A pivotal Phase 3 immunobridging study is planned for initiation in Q4 2026, aligned with formal Scientific Advice from the European Medicines Agency supporting an expedited registration pathway.
Immunobridging results are anticipated in Q2 2027, supporting potential regulatory submissions and procurement discussions. "With a clearly defined regulatory pathway ahead, GEO-MVA is transitioning from preparedness planning to execution," Dodd added. "This program is designed not only to meet regulatory requirements, but to support long-term global readiness by expanding MVA vaccine capacity in a market that remains chronically supply-constrained."
The PLOS Medicine authors emphasize that mpox will continue to pose global risk due to ongoing zoonotic spillover, viral evolution, and efficient transmission networks, particularly in under-resourced health systems. GeoVax believes these realities reinforce the need for redundant, geographically diversified MVA manufacturing capacity. "As the mpox response evolves from emergency reaction to long-term control, vaccine supply resilience becomes a cornerstone of preparedness," said Dodd. "GeoVax is committed to supporting that objective by advancing GEO-MVA as an additional MVA vaccine option for public-health and biodefense stakeholders worldwide."
