GeoVax Advances Mpox/Smallpox Vaccine Toward Phase 3 Trial, Addressing U.S. Supply Vulnerabilities

GeoVax Labs, Inc. has announced the successful completion of fill-finish for the initial clinical batch of GEO-MVA, its next-generation Mpox and 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 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. These trends expose 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 at a time when stockpiles are constrained and demand is growing for resilient, scalable manufacturing capacity.

David Dodd, Chairman and CEO of GeoVax, emphasized the significance of this advancement, stating that completion of fill-finish represents critical steps toward Phase 3 initiation and supports the mission to enhance U.S. and global health security. He noted that America cannot remain dependent on a single foreign manufacturer for MVA-based biodefense vaccines, and GEO-MVA provides a clear path toward a diversified and domestically controlled second-source supply, which he described as an essential component of modern pandemic preparedness.

The GEO-MVA 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 original press release can be viewed at https://www.newmediawire.com.

This manufacturing milestone carries significant implications for public health infrastructure and pandemic preparedness. By establishing domestic manufacturing capacity for MVA-based vaccines, the United States would reduce reliance on international supply chains that proved vulnerable during recent global health emergencies. The accelerated regulatory pathway established by EMA guidance could potentially bring this vaccine candidate to market more quickly than traditional development timelines would allow.

For the biotechnology industry, GeoVax's progress demonstrates the viability of advanced vaccine platforms that can address multiple public health threats. The company's approach of using the MVA platform for both Mpox/smallpox and COVID-19 vaccines suggests potential efficiencies in manufacturing and regulatory processes that could benefit future vaccine development efforts. The successful completion of fill-finish operations also validates the company's manufacturing capabilities at a critical juncture in vaccine development.

The timing of this announcement is particularly relevant given current global health concerns. With Mpox outbreaks continuing in various regions and the persistent threat of smallpox as a potential bioterrorism agent, having multiple vaccine sources represents a strategic advantage for national security and global health stability. The development of GEO-MVA addresses both immediate public health needs and long-term preparedness requirements, creating a more resilient system for responding to infectious disease threats.