GeoVax Responds to WHO's Mpox PHEIC Declaration, Offers Alternative Vaccine Solution Amid Growing Global Threat

GeoVax Labs responds to the World Health Organization's fourth declaration of Mpox as a global public health emergency. Mpox is spreading globally, particularly the highly virulent Clade 1 strain. The company is developing GEO-MVA, a US-based MVA vaccine for Mpox and smallpox, as an alternative to the existing global supply. GeoVax has completed cGMP drug substance manufacturing of GEO-MVA and plans to begin clinical trials in 2026.

GeoVax Labs, Inc. (Nasdaq: GOVX) has responded to the World Health Organization's (WHO) fourth declaration of Mpox as a global public health emergency with the development of its GEO-MVA vaccine. The declaration reflects the ongoing global spread of the highly virulent Clade 1 strain of the Mpox virus, which has prompted heightened international concern and a call to action for more robust vaccine strategies [1].

Mpox, also known as monkey pox, continues to pose a significant threat to global health. The WHO reported rising case counts in both endemic and non-endemic regions, with Clade 1 Mpox now appearing in Europe, Asia, and North America. In the United States, multiple confirmed Clade 1 cases have been reported across various states, including New York, California, Georgia, and New Hampshire. Additionally, Clade 1 viral particles have been detected in wastewater in several U.S. states, suggesting silent transmission may be occurring even before symptomatic cases emerge [1].

The current reliance on a single manufacturer for the preferred Mpox vaccine, based on the Modified Vaccinia Ankara (MVA) platform, presents significant risks to biosecurity, affordability, and equitable distribution. African nations alone have requested 20 million doses for 2025, while global capacity is estimated at only 2–5 million doses annually [1].

GeoVax Labs is actively developing GEO-MVA, a U.S.-based MVA vaccine for Mpox and smallpox, as an alternative to the existing global supply. The company has completed cGMP drug substance manufacturing of GEO-MVA, with fill/finish processes underway. Clinical vials are expected to be available in Q4 2025, enabling clinical trials to begin in 2026 [1].

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, reduce cost, and streamline use of existing manufacturing infrastructure. This development supports U.S.-based rapid deployment in future outbreaks [1].

David Dodd, Chairman & CEO of GeoVax, stated, "WHO’s latest declaration underscores that the Mpox crisis is not behind us - it is escalating. 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. GEO-MVA offers a scalable, cost-effective, and onshore alternative that supports national security, global equity, and pandemic preparedness" [1].

GeoVax is engaged with U.S. federal agencies to align GEO-MVA with government initiatives aimed at onshoring critical pharmaceutical manufacturing and strengthening national pandemic readiness. The company’s proposal under the 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 [1].

GeoVax is calling on global and national policymakers to accelerate regulatory pathways for GEO-MVA and next-generation MVA manufacturing, expand federal funding to ensure rapid scale-up and stockpiling, and preserve early warning surveillance systems such as wastewater monitoring [1].

References:
[1] https://markets.financialcontent.com/wral/article/thenewswire-2025-6-11-geovax-responds-to-whos-fourth-declaration-of-mpox-as-a-global-public-health-emergency