GeoVax Labs, Inc. has announced the successful completion of fill-finish for the initial clinical batch of GEO-MVA, its next-generation Mpox/smallpox vaccine. The product has entered final release evaluation, the concluding quality-control process required before clinical use, positioning the company for Phase 3 immunobridging trial start-up activities in the first quarter of 2026.
Fill-finish represents the sterile, cGMP-regulated process of filling, sealing, and packaging vaccine vials, marking the last manufacturing step before a vaccine may enter clinical study supply channels. With this milestone achieved, GeoVax has moved into the final pre-clinical-deployment phase of its European Medicines Agency-aligned clinical program. In June 2025, the EMA Scientific Advice confirmed 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, accelerated regulatory path to licensure.
This development coincides with 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. GEO-MVA is designed to expand supply, diversify sources, and strengthen biodefense infrastructure. David Dodd, Chairman & CEO of GeoVax, stated that completion of fill-finish represents critical steps toward Phase 3 initiation and a pivotal advancement in the mission to support U.S. and global health security. He emphasized 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 a Modified Vaccinia Ankara-based Mpox/smallpox vaccine designed to expand global vaccine availability at a time of constrained stockpiles and growing demand for resilient, scalable, and geographically diversified manufacturing capacity. It is 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 current status of clinical trials and other updates, visit the company website at https://www.geovax.com.
The milestone underscores the urgent need for domestic MVA vaccine capacity in the United States, particularly as global health threats evolve. By establishing a second-source domestic supplier, GeoVax aims to reduce strategic vulnerabilities in pandemic preparedness while creating a more resilient vaccine supply chain. This advancement comes as health authorities worldwide reassess biodefense strategies following recent infectious disease outbreaks, making GEO-MVA's progress particularly timely for both national security and public health planning.
