GeoVax Labs, Inc. (Nasdaq: GOVX) has expressed support for the newly launched global mpox vaccine stockpile, an initiative funded by Gavi, the Vaccine Alliance, and coordinated through the International Coordinating Group (ICG) on Vaccine Provision, which includes WHO, UNICEF, Médecins Sans Frontières, and the International Federation of Red Cross and Red Crescent Societies. The stockpile, announced on August 27 and scheduled to begin operations later this month, aims to provide countries with timely, equitable, and sustainable access to mpox vaccines during outbreaks.
David A. Dodd, Chairman and CEO of GeoVax, stated, "Establishing a dedicated global mpox vaccine stockpile is an important step forward in moving from reactive outbreak response toward sustained preparedness." He emphasized that equitable access requires durable procurement infrastructure, sufficient vaccine supply, and rapid delivery capabilities. The company applauds WHO, Gavi, and ICG partners for establishing this mechanism and looks forward to engaging with global health partners as its mpox vaccine candidate, GEO-MVA, advances toward pivotal Phase 3 evaluation.
The stockpile builds on the Access and Allocation Mechanism from the 2024 mpox public health emergency and addresses persistent barriers to vaccine access. WHO has identified securing a robust product mix of vaccines and supplies, along with supporting market-shaping efforts, as strategic objectives. These objectives underscore the importance of reliable and diversified vaccine supply for sustained global preparedness. The ICG mechanism has been used for decades to coordinate emergency vaccine supplies for epidemic-prone diseases, and the addition of mpox establishes a durable framework for international health organizations, donors, countries, and manufacturers to collaborate on preparedness and response.
GeoVax is developing GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine candidate for mpox and smallpox prevention. The company has completed key manufacturing, regulatory, clinical, and preclinical milestones for its planned pivotal Phase 3 immune-bridging study in the fourth quarter of 2026. Manufacturing readiness is achieved with GMP clinical product available for the study. Regulatory alignment with the European Medicines Agency supports an expedited immune-bridging pathway comparing GEO-MVA with the licensed MVA-BN vaccine. Clinical readiness includes CRO engagement and site identification for the approximately 500-participant study. Preclinical studies have generated immune responses and neutralizing-antibody data supporting the strategy.
As the stockpile infrastructure develops, GeoVax believes additional qualified MVA vaccine sources can expand supply availability and manufacturing capacity. The company is engaging government agencies and international organizations regarding future procurement and the potential role of GEO-MVA as an additional source of MVA vaccine. Dodd noted, "Creating a sustainable procurement mechanism is an important part of preparedness, but preparedness also requires sufficient and reliable vaccine supply." GeoVax aims to contribute a reliable additional source of MVA vaccine capacity to strengthen global supply resilience.
Beyond GEO-MVA, GeoVax is advancing MVA-X, a next-generation vaccine targeting single-dose protection; continuous-cell-line manufacturing for scalable production; and microarray-based delivery technologies to simplify administration. These efforts are intended to address barriers to global vaccine access. As GEO-MVA progresses, GeoVax looks forward to working with Gavi, WHO, ICG, and other organizations to expand sustainable and equitable access to mpox vaccines worldwide.
