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. The initiative, announced by the World Health Organization (WHO) on September 2 and launched on August 27, is funded by Gavi, the Vaccine Alliance, and coordinated through the International Coordinating Group (ICG) on Vaccine Provision, which includes 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 equitable and timely access to mpox vaccines during outbreaks.
David A. Dodd, Chairman and CEO of GeoVax, emphasized the importance of moving from reactive responses to 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 said. 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 and supporting market-shaping efforts as key strategic objectives, underscoring the need for reliable and diversified vaccine supply.
GeoVax is developing GEO-MVA, a Modified Vaccinia Ankara (MVA)-based vaccine candidate for mpox and smallpox. The company has completed key manufacturing, regulatory, clinical, and preclinical milestones, supporting a planned pivotal Phase 3 immune-bridging study in the fourth quarter of 2026. GMP clinical product has been manufactured and released for use, and the European Medicines Agency (EMA) has provided Scientific Advice supporting an expedited immune-bridging pathway comparing GEO-MVA with the licensed MVA-BN vaccine. Clinical site identification is underway for the approximately 500-participant study, and nonclinical studies have generated supportive immune response and neutralizing antibody data.
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 preparedness organizations regarding future procurement and the potential role of GEO-MVA as an additional source of MVA vaccine. "Preparedness also requires sufficient and reliable vaccine supply," Dodd noted. "Our objective with GEO-MVA is to contribute a reliable additional source of MVA vaccine capacity that can strengthen global supply resilience."
GeoVax is also pursuing next-generation technologies to address barriers to vaccine access, including MVA-X, a candidate for single-dose protection; continuous-cell-line manufacturing for scalable production; and microarray-based delivery technologies to simplify administration. "The launch of this global stockpile represents a significant advance," Dodd said. "The next challenge is ensuring that the vaccines supporting that stockpile can be manufactured at scale and deployed as efficiently and broadly as possible."
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 for international collaboration. GeoVax looks forward to working with Gavi, WHO, the ICG, and other partners to expand sustainable and equitable access to mpox vaccines worldwide. For more information, visit GeoVax's website at www.geovax.com.
