GEO-MVA Provides Potential Opportunity to Expand Mpox Vaccine Supply Amid Growing U.S. and Global Clade 1 Threat
ATLANTA, GA - June 11, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies, today issued a statement in response to the World Health Organization’s (WHO) fourth declaration of Mpox as a Public Health Emergency of International Concern (PHEIC). The WHO’s decision 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.
Mpox continues to pose a significant threat to global health, with WHO reporting rising case counts in endemic and non-endemic regions alike. In particular, Clade 1 Mpox - previously confined to Central Africa - is now appearing in Europe, Asia, and North America. In the United States, multiple confirmed Clade 1 cases have been reported across New York, California, Georgia, and New Hampshire. Additionally, Clade 1 viral particles have been detected in wastewater in North Carolina, California, Alabama and Iowa, suggesting silent transmission may be occurring even before symptomatic cases emerge.
U.S. and Global Reliance on a Single Supplier Threatens Response Capacity
Despite the urgency, the world remains dangerously dependent on a single manufacturer for the preferred Mpox vaccine, based on the Modified Vaccinia Ankara (MVA) platform. This presents significant risks to biosecurity, affordability, and equitable distribution. African nations alone have requested 20 million doses for 2025; global capacity is estimated at only 2–5 million doses annually.
GEO-MVA: America’s Strategic Vaccine Alternative
GeoVax is actively developing GEO-MVA, a U.S.-based MVA vaccine for Mpox and smallpox. GEO-MVA is engineered as an alternative to the existing global supply and has been recognized at global forums as a pivotal component of future pandemic resilience.
GeoVax has completed cGMP drug substance manufacturing of GEO-MVA, with fill/finish processes underway. Clinical vials are expected to be available in Q4 ‘25, enabling clinical trials to begin in 2026.
GEO-MVA is also being developed using an advanced continuous avian cell line manufacturing process, intended to:
- Increase production yield and scalability.
- Eliminate reliance on pathogen-free chicken eggs.
- Reduce cost and streamline use of existing manufacturing infrastructure.
- Enable U.S.-based rapid deployment in future outbreaks.
“WHO’s latest declaration underscores that the Mpox crisis is not behind us - it is escalating,” said David Dodd, Chairman & CEO of GeoVax. “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.”
Strengthening Biosecurity and Public Health Readiness
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 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.
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.
- Preserve early warning surveillance systems such as wastewater monitoring.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. The Company’s lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine currently in three Phase 2 clinical trials, being evaluated as (1) a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, (2) a booster vaccine in patients with chronic lymphocytic leukemia (CLL) and (3) a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. In oncology the lead clinical program is evaluating a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. The Company is also developing GEO-MVA, a vaccine targeting Mpox and smallpox. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. For more information about the current status of our clinical trials and other updates, visit our website: 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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