GeoVax Labs, Inc. (Nasdaq: GOVX) has welcomed the launch of a new global mpox vaccine stockpile, an initiative funded by Gavi, the Vaccine Alliance, and coordinated through the International Coordinating Group (ICG) on Vaccine Provision. The stockpile, announced on August 27 and highlighted by the World Health Organization (WHO) on September 2, is scheduled to begin operations later this month. It aims to provide countries with timely, equitable, and sustainable access to mpox vaccines during future outbreaks, addressing persistent barriers to vaccine access experienced during recent emergencies.
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 applauded WHO, Gavi, and ICG partners for establishing this mechanism and expressed GeoVax's intent to engage with global health partners as GEO-MVA advances toward pivotal Phase 3 evaluation.
The stockpile builds on the Access and Allocation Mechanism established during the 2024 mpox public health emergency. According to WHO, strategic objectives for the stockpile include securing a robust product mix of vaccines and supplies and supporting market-shaping efforts to promote longer-term sustainable access. 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 cooperation.
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 its pivotal Phase 3 immune-bridging study in the fourth quarter of 2026. Manufacturing readiness includes GMP clinical product that has been manufactured, filled, packaged, and released for use in the trial. Regulatory alignment with the European Medicines Agency supports an expedited immune-bridging pathway comparing GEO-MVA with the licensed MVA-BN vaccine. Clinical readiness is advancing with CRO engagement and site identification for the approximately 500-participant study. Preclinical studies have generated orthopoxvirus-specific immune responses and neutralizing-antibody data supporting the immune-bridging strategy.
As the global stockpile infrastructure develops, GeoVax believes that additional qualified MVA vaccine sources can help expand supply availability and manufacturing capacity. The company is engaging government agencies and international preparedness organizations regarding future procurement requirements and the potential role of GEO-MVA as an additional source of MVA vaccine supply. 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 and provide governments and international health organizations with greater supply flexibility.”
Beyond GEO-MVA, GeoVax is pursuing next-generation technologies aimed at addressing further barriers to vaccine access. These include MVA-X, a next-generation MVA approach targeting single-dose protection; continuous-cell-line manufacturing for scalable production; and microarray-based delivery technologies that could simplify administration and facilitate broader deployment. Dodd commented: “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. Our longer-term MVA strategy is focused on that entire continuum.”
GeoVax looks forward to working with Gavi, WHO, the ICG, and other international health organizations to expand sustainable and equitable access to mpox vaccines worldwide. As GEO-MVA progresses toward pivotal Phase 3 evaluation, the company emphasizes its commitment to contributing to global preparedness and biosecurity.
