GeoVax Advances Domestic Mpox Vaccine Production, Targets 2026 Phase 3 Trial

GeoVax Labs, Inc. has completed fill-finish manufacturing for its GEO-MVA mpox/smallpox vaccine, moving the product into final release evaluation and positioning the company to begin Phase 3 immunobridging trial activities in the first quarter of 2026. This milestone represents a critical step in establishing domestic vaccine production capacity in the United States, which currently relies on a single foreign manufacturer for MVA-based biodefense vaccines.

The fill-finish process, which involves sterile filling, sealing, and packaging of vaccine vials under current Good Manufacturing Practice regulations, marks the final manufacturing step before clinical deployment. With this completion, GEO-MVA enters the concluding quality-control phase required before shipment for clinical use. This advancement follows European Medicines Agency guidance from June 2025 confirming that a single Phase 3 immunobridging study demonstrating immune comparability to the approved MVA vaccine Imvanex® would be sufficient for efficacy evaluation, providing an accelerated regulatory path to licensure.

The timing of this manufacturing milestone coincides with increasing global mpox activity, including expanding Clade I outbreaks in Africa and emerging cases in the United States. These developments highlight vulnerabilities in global health security created by dependence on limited vaccine supply chains. David Dodd, Chairman and CEO of GeoVax, emphasized the strategic importance of this development, 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 a diversified and domestically controlled second-source supply."

GEO-MVA is designed as a Modified Vaccinia Ankara-based vaccine to expand global availability during a period of constrained stockpiles and growing demand for resilient, scalable 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 https://www.geovax.com.

This development carries significant implications for pandemic preparedness, particularly as health authorities worldwide confront the reality of recurring infectious disease threats. The establishment of domestic MVA vaccine manufacturing capacity addresses a critical gap in U.S. biodefense infrastructure, potentially reducing response times during public health emergencies. Furthermore, the accelerated regulatory pathway established by EMA guidance could streamline approval processes for similar vaccine candidates, creating a more responsive framework for future vaccine development.

The successful completion of fill-finish operations demonstrates operational progress in vaccine manufacturing capabilities that extend beyond the immediate GEO-MVA program. As vaccine nationalism and supply chain vulnerabilities have become prominent concerns in global health policy, the development of geographically diversified manufacturing capacity represents a strategic investment in health security. The progression toward Phase 3 trials in early 2026 suggests that, pending successful clinical outcomes, domestic MVA vaccine availability could become reality within the coming years, fundamentally altering the landscape of U.S. biodefense preparedness.