ATLANTA, GA - September 9, 2026 - GeoVax Labs, Inc. (Nasdaq: GOVX) has welcomed the establishment of a global mpox vaccine stockpile, a move that could reshape international outbreak response. The initiative, funded by Gavi and 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—was launched on August 27 and is set to begin operations later this month.
The stockpile aims to provide countries with timely, equitable, and sustainable access to mpox vaccines during future outbreaks, addressing a critical gap highlighted during the 2024 mpox public health emergency. WHO has emphasized the need for a robust product mix and market-shaping efforts to ensure long-term supply. This framework represents a shift from reactive measures to sustained preparedness, a development that GeoVax's CEO, David A. Dodd, describes as "an important step forward."
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, and preclinical milestones, positioning it to initiate a pivotal Phase 3 immune-bridging study in the fourth quarter of 2026. The study will compare GEO-MVA's immune responses with those of the licensed MVA-BN vaccine, following scientific advice from the European Medicines Agency (EMA).
Manufacturing readiness is advanced: GMP clinical product has been produced and released for the pivotal study. Regulatory alignment with EMA supports an expedited pathway. Clinical site identification is underway for the approximately 500-participant trial. Preclinical studies have generated orthopoxvirus-specific immune responses and neutralizing-antibody data supporting the immune-bridging strategy.
As the stockpile infrastructure develops, GeoVax believes that additional qualified MVA vaccine sources are essential to expand supply and manufacturing capacity. The company is engaging with government agencies and international preparedness organizations to discuss future procurement needs and the potential role of GEO-MVA. Dodd noted that "preparedness also requires sufficient and reliable vaccine supply," and GeoVax aims to contribute to supply resilience.
Beyond GEO-MVA, GeoVax is pursuing next-generation MVA technologies, including MVA-X for potential single-dose protection, continuous-cell-line manufacturing for scalable production, and microarray-based delivery to simplify administration. These innovations could address barriers to global vaccine access and deployment.
Dodd added, "The launch of this global stockpile represents a significant advance in 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 efficiently." He expressed eagerness to collaborate with Gavi, WHO, ICG, and other partners to expand sustainable access to mpox vaccines worldwide.
The establishment of the stockpile is a strategic move that could influence future procurement and preparedness policies. For GeoVax, it underscores the importance of advancing GEO-MVA through clinical development to potentially serve as a vital component in global health security.
