GeoVax Labs, Inc. has announced a significant regulatory milestone with the European Medicines Agency (EMA) providing positive Scientific Advice for its GEO-MVA vaccine targeting Mpox and smallpox. This advice suggests that a single Phase 3 immuno-bridging trial could suffice for a Marketing Authorization Application in the EU, bypassing earlier phase trials. This development not only reduces the timeline and cost associated with bringing the vaccine to market but also positions GeoVax as a potential key player in addressing the global demand for Mpox vaccines.
The EMA's guidance comes at a critical time, coinciding with the World Health Organization's declaration of Mpox as a public health emergency of international concern and outbreaks of Clade I across multiple continents. GeoVax's GEO-MVA vaccine could offer a much-needed alternative to the currently monopolistic market, enhancing global vaccine supply security. The company plans to initiate its Phase 3 trial in the second half of 2026, with manufacturing processes already in place to support near-term supply needs.
David Dodd, Chairman and CEO of GeoVax, highlighted the strategic and commercial significance of this development, noting it as a potential inflection point for the company. The expedited approval path and reduced development risk underscore GeoVax's transition from a development-stage biotech to a near-term commercial vaccine company, with significant implications for investors and public health stakeholders alike.
