GeoVax Reaffirms Commitment to Evidence-Based Vaccine Safety as Development of GEO-CM04S1 Advances

GeoVax Labs, Inc. has reaffirmed its commitment to rigorous, science-based evaluation of vaccine safety following discussions by federal officials at the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices meeting regarding reports of adverse events related to COVID-19 vaccination. The clinical-stage biotechnology company emphasized the importance of transparent pharmacovigilance and ongoing review of safety data for all vaccines, noting that systems such as the Vaccine Adverse Event Reporting System are designed to detect potential signals that require further thorough, independent analysis.

The company's statement comes as it advances development of GEO-CM04S1, an investigational multi-antigen COVID-19 vaccine based on the Modified Vaccinia Ankara viral vector platform. This platform has a decades-long history of safe use, including in immunocompromised individuals, pregnant women and pediatric populations in prior vaccine settings. GEO-CM04S1 is currently being evaluated in multiple ongoing Phase 2 clinical trials, with particular focus on patients with hematologic cancers resulting in significantly weakened immune systems that do not appear to adequately respond to current authorized COVID-19 vaccines.

David Dodd, Chairman and CEO of GeoVax, stated that in this moment of heightened focus on vaccine safety, the company's mission to develop vaccines that address the needs of populations most at risk from various infectious diseases is more critical than ever. For GEO-CM04S1, this means addressing the critical needs of immunocompromised individuals for whom existing vaccine options may provide insufficient protection. The company remains committed to transparent science, thorough safety monitoring, and collaboration with regulatory authorities as it works to deliver this much-needed solution.

To date, GEO-CM04S1 has demonstrated a favorable safety profile under the oversight of independent Data and Safety Monitoring Boards and encouraging immune response within immune-compromised patients. 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. The company's approach recognizes that reports in VAERS alone do not establish causality, and GeoVax supports the continued application of rigorous scientific standards to assess vaccine safety.

The development of GEO-CM04S1 represents an important advancement in addressing vaccine equity and effectiveness for vulnerable populations. Immunocompromised patients, particularly those with hematologic cancers, have been identified as a group that may not mount adequate immune responses to current COVID-19 vaccines, leaving them at continued risk of severe disease. GeoVax's vaccine candidate is being evaluated as both a primary vaccine for immunocompromised patients and as a booster vaccine in specific patient populations, including those with chronic lymphocytic leukemia.