GeoVax Labs, Inc., a clinical-stage biotechnology company, 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 (https://journals.plos.org/plosmedicine/article/file?id=10.1371/journal.pmed.1004893&type=printable) that emphasizes ongoing transmission, morbidity, and mortality, particularly across Africa, driven by evolving viral clades, constrained vaccine supply, and persistent inequities in access to countermeasures.
David Dodd, Chairman and Chief Executive Officer of GeoVax, stated that the company strongly endorses the message that complacency would be a costly mistake. "The data are clear: mpox continues to circulate, evolve, and disproportionately impact vulnerable populations," Dodd said. "A durable response requires sustained investment, diversified vaccine supply, and readiness that extends beyond reactive surge manufacturing."
GeoVax is developing GEO-MVA, a Modified Vaccinia Ankara-based vaccine for the prevention of mpox and smallpox, specifically designed to address structural vulnerabilities highlighted in the PLOS Medicine analysis. The program aims to reduce the world's continued dependence on a single manufacturer for licensed MVA vaccine supply, which represents a critical weakness in global health security.
Key program milestones include completion of GEO-MVA clinical material, positioning the program for late-stage clinical execution and supply readiness. The company plans to initiate a pivotal Phase 3 immunobridging study in the fourth quarter of 2026, aligned with formal Scientific Advice from the European Medicines Agency supporting an expedited registration pathway. Immunobridging results are anticipated in the second quarter of 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 a global risk due to ongoing zoonotic spillover, viral evolution, and efficient transmission networks, particularly in settings where health systems are under-resourced. GeoVax believes these realities reinforce the need for redundant, geographically diversified MVA manufacturing capacity—a principle that underpins the GEO-MVA program.
"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."
The implications of this announcement extend beyond immediate public health concerns to address systemic vulnerabilities in global vaccine supply chains. By developing an alternative MVA vaccine source, GeoVax aims to create redundancy that could prevent future shortages during outbreaks. This approach recognizes that infectious disease threats require sustained preparedness rather than reactive responses, particularly for diseases like mpox that continue to evolve and disproportionately affect regions with limited healthcare resources.
For stakeholders in public health, biodefense, and global health security, the development of GEO-MVA represents progress toward more resilient systems capable of responding to ongoing and emerging threats. The program's alignment with regulatory guidance from the European Medicines Agency suggests a viable pathway toward market availability, potentially providing governments and health organizations with additional options for protecting vulnerable populations against mpox and related orthopoxvirus threats.
