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, marking a significant step toward Phase 3 clinical trial initiation in early 2026. This manufacturing milestone comes at a time of increasing global Mpox activity and exposes vulnerabilities in U.S. biodefense infrastructure that relies on a single foreign supplier for MVA-based vaccines.
The fill-finish process represents the final sterile manufacturing step before vaccine vials can enter clinical study supply channels. With this process complete and GEO-MVA now undergoing final release evaluation, GeoVax has positioned itself to begin Phase 3 immunobridging trial start-up activities in the first quarter of 2026. The company received regulatory guidance from the European Medicines Agency in June 2025 confirming that a single Phase 3 study demonstrating immune comparability to the approved MVA vaccine, Imvanex®, would be sufficient for efficacy evaluation, providing an accelerated path to licensure.
This development addresses a critical gap in U.S. pandemic preparedness. Current global dependence on a sole foreign MVA vaccine supplier creates significant vulnerabilities, particularly as Mpox activity increases worldwide with expanding Clade I outbreaks in Africa and emerging cases in the United States. GEO-MVA is designed to expand supply, diversify sources, and strengthen biodefense infrastructure by providing a domestically controlled second-source supply option.
David Dodd, Chairman & CEO of GeoVax, emphasized the importance of this milestone, stating that America cannot remain dependent on a single foreign manufacturer for MVA-based biodefense vaccines. The GEO-MVA program represents a clear path toward diversified vaccine supply, which he described as an essential component of modern pandemic preparedness. This advancement also demonstrates operational progress for the company's shareholders and partners.
GEO-MVA is a Modified Vaccinia Ankara-based vaccine designed 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. The company maintains a strong intellectual property portfolio supporting its technologies and product candidates, with worldwide rights for its developments.
The timing of this manufacturing achievement aligns with broader public health concerns about vaccine supply chain resilience. As infectious disease threats continue to evolve, the ability to rapidly develop and manufacture vaccines domestically becomes increasingly critical for national security and global health stability. The progress with GEO-MVA represents not just a corporate milestone but a tangible step toward reducing strategic vulnerabilities in the U.S. vaccine supply ecosystem.
For more information about GeoVax's clinical programs and corporate developments, visit their website at https://www.geovax.com. The company's broader portfolio includes GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, and Gedeptin®, an oncolytic solid tumor gene-directed therapy that recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers.
