GeoVax Labs, Inc. announced the successful completion of fill-finish for the initial clinical batch of GEO-MVA, its next-generation Mpox/smallpox vaccine, with the product now entering final release evaluation before clinical use. This manufacturing milestone positions the company for Phase 3 immunobridging trial start-up activities in the first quarter of 2026, representing a significant step toward addressing vulnerabilities in U.S. biodefense infrastructure. The fill-finish process marks the last manufacturing step before a vaccine may enter clinical study supply channels, with GEO-MVA undergoing final quality-control and compliance procedures.
This advancement follows European Medicines Agency (EMA) Scientific Advice from June 2025 confirming that a single Phase 3 immunobridging study demonstrating immune comparability to the approved MVA vaccine, Imvanex®, would be sufficient to evaluate GEO-MVA's efficacy, providing a clear regulatory path to licensure. This development comes amid increasing Mpox activity globally, including expanding Clade I outbreaks in Africa and emerging cases in the United States, which exposes vulnerabilities associated with global dependence on a sole foreign MVA vaccine supplier. David Dodd, Chairman & CEO of GeoVax, emphasized the strategic importance of this milestone, stating that America cannot remain dependent on a single foreign manufacturer for MVA-based biodefense vaccines and that GEO-MVA provides a clear path toward diversified and domestically controlled second-source supply.
GEO-MVA is designed to expand global vaccine availability at a time of constrained stockpiles and growing demand for resilient, scalable, and geographically diversified manufacturing capacity. The vaccine represents a core asset within GeoVax's broader MVA platform, which also includes next-generation COVID-19 and other infectious disease programs. For more information about the company's clinical trials and updates, visit their website at https://www.geovax.com.
The completion of fill-finish operations and progression toward Phase 3 clinical evaluation represents a critical advancement in pandemic preparedness, particularly as global health authorities seek to strengthen vaccine supply chains and reduce dependence on single-source manufacturers. This milestone underscores the operational progress GeoVax is making in developing domestic vaccine manufacturing capabilities that could enhance national security and global health resilience against infectious disease threats.
