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 this 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, which Dodd described as 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 current status of clinical trials and other updates, visit www.geovax.com.
