The World Health Organization's recent declaration of Mpox as a Public Health Emergency of International Concern (PHEIC) 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 (RRPV) 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.
