GeoVax Completes Manufacturing Milestone for Next-Generation Mpox/Smallpox Vaccine
TL;DR
GeoVax's GEO-MVA vaccine completion positions the company to capture market share by providing a domestic alternative to foreign MVA vaccines, strengthening U.S. biodefense independence.
GeoVax completed fill-finish manufacturing for GEO-MVA, entering final release evaluation before Phase 3 immunobridging trials in Q1 2026, following EMA's accelerated regulatory pathway.
GEO-MVA vaccine development enhances global pandemic preparedness by diversifying vaccine supply, reducing dependence on single sources, and improving health security against Mpox and smallpox threats.
GeoVax's GEO-MVA vaccine uses Modified Vaccinia Ankara technology to create a next-generation smallpox/Mpox vaccine, advancing through final quality checks before clinical trials begin.
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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.
Curated from NewMediaWire
