GeoVax Highlights U.S. Government Investment in Orthopox Preparedness as Validation of Long-Term Vaccine Readiness

GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing vaccines and immunotherapies, today commented on the U.S. government’s recent procurement of additional ACAM2000® (Emergent BioSolutions) smallpox vaccine, noting that the award reinforces the continued strategic importance of maintaining robust orthopoxvirus preparedness capabilities. The procurement reflects the U.S. government’s ongoing commitment to maintaining the Strategic National Stockpile and sustaining multiple medical countermeasures against smallpox and mpox threats.

Continued federal investment demonstrates that orthopox preparedness remains an enduring national priority requiring long-term investment in vaccine manufacturing capacity, supply chain resilience, and diversified medical countermeasure capabilities. ‘Government procurement decisions are driven by long-term national preparedness objectives rather than short-term outbreak cycles,’ said David Dodd, Chairman and Chief Executive Officer of GeoVax. ‘Continued federal investment in orthopox preparedness reinforces the importance of resilient manufacturing capacity, diversified vaccine supply, and regulatory readiness. We believe this environment strongly supports the accelerated development of GEO-MVA through its expedited regulatory pathway and the expansion of U.S.-based MVA vaccine manufacturing to strengthen America’s long-term public health and biodefense preparedness.’

The announcement comes amid an evolving global health security landscape marked by recurring mpox outbreaks, continued emergence of high-consequence infectious diseases, and renewed emphasis on domestic manufacturing of critical medical countermeasures. Together, these trends reinforce the importance of maintaining a resilient and diversified biodefense infrastructure capable of responding to both naturally occurring outbreaks and potential biological threats.

GEO-MVA is GeoVax’s Modified Vaccinia Ankara (MVA)-based vaccine candidate being developed for protection against mpox and smallpox. Following positive scientific advice from the European Medicines Agency (EMA), GeoVax is pursuing an expedited clinical development strategy utilizing immunobridging to an approved MVA vaccine, enabling the program to advance directly into a single, registrational Phase 3 study without conducting traditional Phase 1 or Phase 2 clinical efficacy studies. The pivotal Phase 3 study is scheduled to initiate in the fourth quarter of 2026 with data readout of the immunobridging portion of the study anticipated by mid-2027.

The program is intended to expand domestic manufacturing capacity, strengthen orthopoxvirus vaccine supply resilience, and complement broader U.S. and international preparedness efforts by providing an additional source of MVA vaccine for public health and biodefense applications. The continued emphasis on orthopox preparedness, combined with recent federal initiatives supporting domestic production of critical medical countermeasures, reinforces the strategic importance of expanding U.S.-based vaccine manufacturing capacity. GeoVax believes these long-term policy priorities are well aligned with the objectives of its GEO-MVA program and the broader goal of strengthening America’s medical countermeasure infrastructure.

For more information, visit www.geovax.com.

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