The World Health Organization's recent declaration of Mpox as a Public Health Emergency of International Concern for the fourth time underscores the escalating threat posed by the Clade 1 strain of the Mpox virus. This strain, previously confined to Central Africa, has now been detected in Europe, Asia, and North America, including multiple U.S. states, signaling a growing global health crisis. GeoVax Labs, Inc., a clinical-stage biotechnology company, is responding to this crisis by advancing the development of GEO-MVA, a U.S.-based MVA vaccine for Mpox and smallpox. The company's efforts come at a critical time when the world's reliance on a single manufacturer for the preferred Mpox vaccine poses significant risks to biosecurity, affordability, and equitable distribution.
With African nations alone requesting 20 million doses for 2025 against a global production capacity of only 2–5 million doses annually, the need for alternative vaccine sources is clear. GEO-MVA is being developed using an advanced continuous avian cell line manufacturing process, which aims to increase production yield and scalability, eliminate reliance on pathogen-free chicken eggs, and reduce costs. GeoVax has completed cGMP drug substance manufacturing of GEO-MVA, with clinical vials expected to be available in Q4 '25, paving the way for clinical trials in 2026. David Dodd, Chairman & CEO of GeoVax, emphasized the importance of expanding domestic vaccine capacity in light of the WHO's declaration.
"As Clade 1 spreads in the U.S. and globally, we must act now to expand domestic vaccine capacity. Single-source dependency threatens access during geopolitical or logistical disruptions," Dodd stated. GEO-MVA represents a scalable, cost-effective, and onshore alternative that supports national security, global equity, and pandemic preparedness. GeoVax is also collaborating with U.S. federal agencies to align GEO-MVA with initiatives aimed at strengthening national pandemic readiness. The company's proposal under BARDA's Rapid Response Partnership Vehicle was selected for award, pending funding, to scale MVA-based vaccine production using advanced U.S. biomanufacturing technologies.
The ongoing global spread of Mpox, particularly the Clade 1 strain, highlights the urgent need for diversified vaccine sources and robust public health strategies. GeoVax's development of GEO-MVA offers a promising solution to enhance global vaccine supply, ensuring preparedness for current and future outbreaks. The implications of this announcement extend beyond immediate outbreak response, addressing systemic vulnerabilities in global health infrastructure that have been exposed by the current Mpox crisis and previous pandemics.
