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Gavi-funded, ICG-Coordinated Initiative Establishes Long-Term Infrastructure for Timely and Equitable Mpox Vaccine Access During Outbreaks
New Stockpile Framework Supports Sustainable Supply and Long-Term Global Preparedness
ATLANTA, GA – September 9, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies against infectious diseases and cancers, today 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.
In a September 2 announcement, the World Health Organization (WHO) highlighted the initiative, which was launched on August 27 and is funded by Gavi (the Vaccine Alliance) and coordinated through the International Coordinating Group (ICG) on Vaccine Provision, whose 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 and establishes a long-term mechanism for global mpox vaccine access and outbreak response.
“Establishing a dedicated global mpox vaccine stockpile is an important step forward in moving from reactive outbreak response toward sustained preparedness,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “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.
GEO-MVA: Advancing Toward Pivotal Phase 3
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 planned initiation of its pivotal Phase 3 immune-bridging study in the fourth quarter of 2026.
GEO-MVA program readiness includes:
- Manufacturing Readiness: GMP clinical product has been manufactured, filled, packaged and released for use in the pivotal clinical study.
- Regulatory Alignment: European Medicines Agency (EMA) Scientific Advice supports an expedited immune-bridging development pathway comparing GEO-MVA with the licensed MVA-BN vaccine.
- Clinical Readiness: CRO engagement and clinical-site identification are advancing in support of the targeted approximately 500-participant pivotal study.
- Preclinical Support: Comparative nonclinical studies have generated 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.
“Creating a sustainable procurement mechanism is an important part of preparedness, but preparedness also requires sufficient and reliable vaccine supply,” Dodd continued. “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.”
Extending Access Through Next-Generation MVA Technologies
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.
“The launch of this global stockpile represents a significant advance in the infrastructure for equitable mpox vaccine access and outbreak response,” 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. 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, we look 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,” Dodd added.
About GEO-MVA
GEO-MVA is GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine being developed for protection against mpox and smallpox. Following Scientific Advice from the European Medicines Agency, GeoVax is pursuing an immune-bridging development strategy intended to compare immune responses generated by GEO-MVA with those generated by the licensed MVA-BN comparator.
GeoVax is developing GEO-MVA to expand global access to MVA vaccine supply and scalable production capabilities. The Company believes GEO-MVA has the potential to become an important strategic preparedness asset by providing governments and international public health organizations with an additional source of MVA vaccine supporting biosecurity and orthopoxvirus preparedness.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the fourth quarter of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
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