EQS-News: GeoVax Highlights Urgent Need for Multisource Mpox Vaccine Supply Following California Clade 1 Cases

EMA Endorses Expedited Development Pathway for GEO-MVA; Company Advances U.S.-Based Continuous Cell Line Manufacturing to Address Fragile Supply Chains and Align With Federal Pandemic Preparedness Initiatives

ATLANTA, GA - October 20, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing multi-antigen vaccines and immunotherapies for infectious diseases and cancer, today emphasized the urgent public health threat posed by the confirmation of locally transmitted Clade 1 Mpox cases in Los Angeles County, California (http://www.publichealth.lacounty.gov/phcommon/public/media/mediapubhpdetail.cfm?prid=5161).

These cases represent the first known local spread of the more severe strain in the United States, underscoring the fragility of global vaccine supply chains and the critical need for second-source solutions.

Public Health Threat from Clade 1 Mpox

The California Department of Public Health confirmed that three individuals were recently hospitalized with Clade 1 mpox in Los Angeles County, despite having no history of international travel. Clade 1 mpox is associated with more severe illness than Clade 2, which has circulated in the U.S. since 2022.

Fragile Vaccine Supply and Urgent Demand

The U.S. remains reliant on a single, foreign manufacturer for the currently approved MVA-based mpox vaccine. This dependency creates vulnerabilities in cost, supply chain security, and surge capacity - at a time when outbreaks in Africa, Europe, and now the U.S. are escalating.

“Relying on a single overseas manufacturer for such a critical biosecurity countermeasure is unwise and unsustainable,” said David Dodd, Chairman & CEO of GeoVax. “The emergence of locally spread Clade 1 mpox in California is a warning sign. America needs a diversified vaccine arsenal that includes U.S.-based manufacturing and scalable platforms designed for both epidemic response and national stockpiling.”

GEO-MVA: Expedited EMA Pathway and U.S. Onshoring Strategy

GeoVax’s GEO-MVA vaccine, based on Modified Vaccinia Ankara (MVA), has received favorable Scientific Advice from the European Medicines Agency (EMA), confirming a streamlined path directly to a Phase 3 immuno-bridging trial. This regulatory guidance accelerates GEO-MVA’s trajectory toward potential market authorization and strengthens its prospective role as a critical additional source MVA vaccine.

In parallel, GeoVax is advancing a next-generation continuous avian cell line (AGE1) manufacturing platform, designed to replace egg-based vaccine production. This innovation is anticipated to result in rapid, high-volume, U.S.-based production - reducing costs, shortening deployment timelines, and reinforcing national security.

Alignment with Federal Pandemic Preparedness Initiatives

GeoVax’s efforts directly align with a wave of federal actions designed to modernize America’s pandemic response:

• White House Executive Order on pharmaceutical independence, directing FDA and other agencies to accelerate domestic capacity and reduce foreign dependency.
• HHS-ASPR-DARPA EQUIP-A-Pharma Initiative, advancing AI-driven, modular U.S.-based manufacturing platforms for critical medicines.
• Congressional Bipartisan Action, including legislation championed by Senators Joni Ernst (R-IA) and Lisa Blunt Rochester (D-DE), seeking to onshore critical medical manufacturing.
• National Security Commission on Emerging Biotechnology (NSCEB) Recommendations, calling for a $15 billion investment in U.S.-owned biotech infrastructure.

“These federal initiatives are clear signals that America is serious about pandemic readiness and supply chain security,” said Dodd. “GeoVax is uniquely positioned to answer that call with our clinically validated MVA platform, EMA-endorsed expedited development plan, and continuous cell line manufacturing strategy.”

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. GeoVax is also developing a vaccine targeting Mpox and smallpox and, based on recent EMA regulatory guidance, anticipates progressing directly to a Phase 3 clinical evaluation, omitting Phase 1 and Phase 2 trials. 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.

Company Contact:
info@geovax.com
678-384-7220

Media Contact:
Jessica Starman
media@geovax.com 

View the original release on www.newmediawire.com