GeoVax Completes Fill-Finish for GEO-MVA Vaccine, Advancing Phase 3 Trial Timeline to Early 2026

The successful completion of fill-finish for the initial clinical batch of GEO-MVA represents a significant manufacturing milestone for GeoVax Labs, moving the vaccine into final release evaluation before clinical deployment. This sterile, cGMP-regulated process of filling, sealing, and packaging vaccine vials marks the last manufacturing step before a vaccine may enter clinical study supply channels, positioning the company for Phase 3 immunobridging trial start-up activities in the first quarter of 2026.

The regulatory pathway for GEO-MVA was clarified in June 2025 when the European Medicines Agency (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. This provides a clear, accelerated regulatory path to licensure that aligns with the company's clinical program strategy. The EMA guidance allows GeoVax to progress directly to Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials that would typically be required for vaccine development programs.

This manufacturing achievement comes at a critical time as global mpox activity increases, including expanding Clade I outbreaks in Africa and emerging cases in the United States. These developments 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 vaccine stockpiles face constraints and demand grows for resilient, scalable, and geographically diversified manufacturing capacity.

David Dodd, Chairman & 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. The GEO-MVA program provides a clear path toward a diversified and domestically controlled second-source supply, which represents an essential component of modern pandemic preparedness. This milestone underscores the operational progress the company is delivering for shareholders and partners while addressing urgent national security concerns related to vaccine supply chains.

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. As a Modified Vaccinia Ankara (MVA)-based mpox/smallpox vaccine, GEO-MVA addresses both current public health needs and long-term biodefense requirements. The company's progress with GEO-MVA manufacturing and clinical planning demonstrates how biotechnology companies are responding to global health security challenges through innovative vaccine development and strategic manufacturing partnerships.

For more information about the company's clinical programs and technologies, visit https://www.geovax.com. The completion of fill-finish operations represents a tangible step toward reducing foreign dependence on critical medical countermeasures while advancing a vaccine candidate that could significantly enhance global preparedness against orthopoxvirus threats including mpox and smallpox.