GeoVax Receives EMA Scientific Advice for Phase 3 Trial of Mpox and Smallpox Vaccine Candidate

GeoVax Labs, Inc. has received formal Scientific Advice from the European Medicines Agency confirming regulatory alignment on the company's proposed pivotal Phase 3 immunobridging trial design for GEO-MVA, its Modified Vaccinia Ankara-based vaccine candidate for preventing Mpox and smallpox. The EMA's feedback concurs with GeoVax's strategy to evaluate GEO-MVA through a single, pivotal Phase 3 immuno-bridging study versus the approved MVA vaccine, Imvanex®, and supports proceeding directly into this trial without additional Phase 1 or Phase 2 clinical studies.

This regulatory milestone enables GeoVax to accelerate operational planning toward implementation and initiation of the Phase 3 program, currently projected to begin in the second half of 2026. David Dodd, Chairman and Chief Executive Officer of GeoVax, stated that the formal Scientific Advice represents a pivotal step forward for GEO-MVA and meaningfully de-risks the regulatory path in Europe. EMA's concurrence positions GeoVax to move efficiently toward a single, registrational Phase 3 study, marking a major milestone on the path toward commercialization.

The Scientific Advice confirms that non-inferiority immunogenicity endpoints are acceptable to support a future Marketing Authorization Application and that GeoVax's proposed clinical safety database is sufficient to support registration, assuming successful trial outcomes. EMA's feedback provides clarity and confidence across proposed clinical and quality dimensions, allowing the company to focus on execution rather than redesign of its development strategy. This advice follows GeoVax's previous announcement of favorable preliminary EMA guidance announced in June 2025 and marks the transition from regulatory alignment to regulatory execution.

These milestones substantially strengthen GEO-MVA's development profile and reinforce its potential role in expanding global Mpox and smallpox vaccine supply beyond the current single-supplier paradigm. Dodd added that with formal EMA Scientific Advice now in hand, GEO-MVA moves from a conceptual regulatory pathway to a clearly defined and executable development plan. As global health authorities continue to emphasize preparedness, resilience, and diversification of vaccine supply, GEO-MVA is positioned to play an important role. For more information about the company's clinical trials and updates, visit www.geovax.com.

The development is significant because it addresses critical gaps in global vaccine preparedness. The current single-supplier paradigm for Mpox and smallpox vaccines creates vulnerabilities in public health systems, particularly during outbreaks or bioterrorism threats. GEO-MVA's accelerated regulatory pathway could provide health authorities with additional options for stockpiling and distribution, enhancing global health security. For the biotechnology industry, this regulatory alignment demonstrates how early engagement with agencies like EMA can streamline development timelines and reduce uncertainty, potentially serving as a model for other vaccine developers.

For investors and stakeholders, the EMA's endorsement reduces regulatory risk and provides clearer visibility into GEO-MVA's commercialization timeline. The immunobridging approach, which compares immune responses to an already-approved vaccine rather than conducting traditional efficacy trials, represents an efficient regulatory strategy that could become more common for vaccines targeting diseases with established prevention methods. This development comes at a time when global health organizations are prioritizing vaccine supply diversification, making GEO-MVA's progress particularly relevant to pandemic preparedness initiatives worldwide.