Company Underscores Rigorous Safety Monitoring and Long History of the MVA Platform as Development of GEO-CM04S1 Advances
ATLANTA, GA - September 22, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines, today reaffirmed its commitment to rigorous, science-based evaluation of vaccine safety. The statement follows discussions by federal officials at the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) meeting, held September 18-19, 2025, regarding reports of adverse events related to COVID-19 vaccination.
GeoVax recognizes the importance of transparent pharmacovigilance and ongoing review of safety data for all vaccines. Systems such as the Vaccine Adverse Event Reporting System (VAERS) are designed to detect potential signals that require further thorough, independent analysis. Reports in VAERS alone do not establish causality, and GeoVax supports the continued application of rigorous scientific standards to assess vaccine safety.
About GEO-CM04S1
GEO-CM04S1 is GeoVax’s investigational multi-antigen COVID-19 vaccine based on the Modified Vaccinia Ankara (MVA) viral vector platform. MVA is a non-replicating vector with a decades-long history of safe use, including in immunocompromised individuals, pregnant women and pediatric populations in prior vaccine settings.
CM04S1 is being evaluated in multiple ongoing Phase 2 clinical trials, including studies focused on patients with hematologic cancers resulting in significantly weakened immune systems that do not appear to adequately respond to the current authorized COVID-19 vaccines. To date, GEO-CM04S1 has demonstrated a favorable safety profile under the oversight of independent Data and Safety Monitoring Boards (DSMBs) and encouraging immune response within immune-compromised patients.
Commitment to Patients and Public Health
“In this moment of heightened focus on vaccine safety, our mission is more critical than ever: to develop vaccines that address the needs of populations most at risk from various infectious diseases,” said David Dodd, Chairman and CEO of GeoVax. “For GEO-CM04S1, this means addressing the critical needs of immunocompromised individuals for whom existing vaccine options may provide insufficient protection. We remain committed to transparent science, thorough safety monitoring, and collaboration with regulatory authorities as we work to deliver this much-needed solution.”
GeoVax emphasizes that ongoing clinical trials are designed with robust pharmacovigilance frameworks and long-term follow-up to ensure safety and efficacy are comprehensively assessed.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines against infectious diseases and therapies for solid tumor cancers. GEO-CM04S1 is a next-generation, multi-antigen 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
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