GeoVax Labs, Inc. (Nasdaq: GOVX) today reaffirmed its commitment to rigorous, science-based evaluation of vaccine safety, following recent discussions at the CDC's Advisory Committee on Immunization Practices (ACIP) meeting regarding reports of adverse events related to COVID-19 vaccination. The company emphasizes 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 (VAERS) are designed to detect potential signals that require further thorough, independent analysis. GeoVax supports the continued application of rigorous scientific standards to assess vaccine safety, as reports in VAERS alone do not establish causality.
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. The vaccine is currently being evaluated in multiple ongoing Phase 2 clinical trials, including studies focused on patients with hematologic cancers who have significantly weakened immune systems and 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.
“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.
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 in this release are based on current expectations and projections. Actual results may differ materially due to various factors, including whether GeoVax can obtain acceptable results from ongoing or future clinical trials, its products can provoke desired responses, viral vector technology amplifies immune responses adequately, products can be developed with desired characteristics in a timely manner, products will be safe for human use, vaccines will effectively prevent targeted infections, products will receive regulatory approvals, GeoVax raises required capital, competitive products emerge, and favorable agreements are secured. Further information on risk factors is contained in periodic reports filed with the SEC.
