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 provide countries with timely, equitable, and sustainable access to vaccines during future outbreaks. The initiative, announced by the World Health Organization (WHO) on September 2, was launched on August 27 and is funded by Gavi, the Vaccine Alliance, and coordinated through the International Coordinating Group (ICG) on Vaccine Provision. Partners include WHO, UNICEF, Médecins Sans Frontières (MSF), and the International Federation of Red Cross and Red Crescent Societies (IFRC). The stockpile is scheduled to begin operations later this month, establishing a long-term mechanism for global mpox vaccine access and outbreak response.
David A. Dodd, Chairman and Chief Executive Officer 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. We applaud WHO, Gavi, and the ICG partners for establishing this important mechanism and look forward to engaging with global health partners as our mpox vaccine candidate, GEO-MVA, advances toward pivotal Phase 3 evaluation and potential future supply.”
The new stockpile builds upon the Access and Allocation Mechanism established during the 2024 mpox public health emergency and responds to persistent barriers to vaccine access experienced during recent outbreaks. WHO has identified securing a robust product mix of vaccines and supplies and supporting market-shaping efforts to promote longer-term sustainable access to mpox vaccines among the stockpile’s strategic objectives. These objectives underscore the importance of reliable and diversified vaccine supply as part of sustained global preparedness. The ICG mechanism has been used for decades to coordinate emergency vaccine supplies for epidemic-prone diseases. The addition of mpox establishes a durable framework through which international health organizations, donors, countries, and vaccine manufacturers can support preparedness and rapid outbreak response.
GeoVax is developing GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine candidate for the prevention of mpox and smallpox. 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. Program readiness includes GMP clinical product manufactured, filled, packaged, and released for use in the pivotal clinical study; European Medicines Agency (EMA) Scientific Advice supporting an expedited immune-bridging development pathway comparing GEO-MVA with the licensed MVA-BN vaccine; CRO engagement and clinical-site identification advancing in support of the targeted approximately 500-participant pivotal study; and comparative nonclinical studies generating orthopoxvirus-specific immune responses and neutralizing-antibody data supporting the planned immune-bridging strategy.
As the new global stockpile infrastructure develops, GeoVax believes additional qualified MVA vaccine sources can help expand supply availability, manufacturing capacity, and preparedness for future outbreaks. 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 advancing GEO-MVA toward potential registration and supply, GeoVax is pursuing technologies intended to address additional barriers to global vaccine access and administration. These efforts include development of MVA-X, a next-generation MVA vaccine approach targeting single-dose protection; advancement of continuous-cell-line manufacturing intended to support scalable production; and evaluation of microarray-based delivery technologies that could potentially simplify vaccine 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 – from expanding supply, to pursuing single-dose protection, to simplifying how vaccines may ultimately be administered in the field.”
As GEO-MVA progresses toward pivotal Phase 3 evaluation, GeoVax looks forward to working with Gavi, WHO, the ICG, and other international health organizations toward the shared objective of expanding sustainable and equitable access to mpox vaccines worldwide. For more information about GeoVax, visit GeoVax's website.
