GeoVax Welcomes Global Mpox Vaccine Stockpile Launch, Highlights GEO-MVA Readiness

GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies, has welcomed the launch of a new global mpox vaccine stockpile designed to ensure timely and equitable access during outbreaks. The initiative, announced on August 27 and funded by Gavi, the Vaccine Alliance, is coordinated by 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 is set to begin operations later this month, establishing a long-term mechanism for outbreak response.

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. Equitable access requires more than having vaccines available after an outbreak begins. It requires durable procurement infrastructure, sufficient vaccine supply, and the ability to rapidly deliver vaccine protection where it is needed." He emphasized that GeoVax looks forward to engaging with global health partners as its mpox vaccine candidate, GEO-MVA, advances toward pivotal Phase 3 evaluation and potential future supply.

The new stockpile builds on the Access and Allocation Mechanism established during the 2024 mpox public health emergency, addressing persistent barriers to vaccine access. WHO has identified securing a robust product mix and supporting market-shaping efforts as key objectives, underscoring the importance of reliable and diversified vaccine supply. The ICG mechanism has been used for decades for epidemic-prone diseases, and its expansion to mpox provides a durable framework for international coordination.

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, supporting the planned initiation of a pivotal Phase 3 immune-bridging study in the fourth quarter of 2026. Program readiness includes GMP clinical product manufactured and released, EMA Scientific Advice supporting an expedited pathway, CRO engagement for a ~500-participant study, and comparative nonclinical data supporting the immune-bridging strategy.

As the stockpile infrastructure develops, GeoVax believes additional qualified MVA vaccine sources can help expand supply and manufacturing capacity. The company is engaging government agencies and international organizations regarding future procurement. Dodd added, "Creating a sustainable procurement mechanism is an important part of preparedness, but preparedness also requires sufficient and reliable vaccine supply. Our objective with GEO-MVA is to contribute a reliable additional source of MVA vaccine capacity that can strengthen global supply resilience."

Beyond GEO-MVA, GeoVax is pursuing next-generation technologies to address access barriers, including MVA-X for single-dose protection, continuous-cell-line manufacturing, and microarray-based delivery to simplify administration. Dodd concluded, "The launch of this global stockpile represents a significant advance in the infrastructure for equitable mpox vaccine access and outbreak response. The next challenge is ensuring that the vaccines supporting that stockpile can be manufactured at scale and deployed as efficiently and broadly as possible."