ATLANTA, GA - March 3, 2025 (NEWMEDIAWIRE) - GeoVax Labs, Inc. (Nasdaq: GOVX), a leader in developing vaccines and immunotherapies for infectious diseases and cancer, underscores the strategic importance of its Modified Vaccinia Ankara (MVA) vaccine platform in helping to bolster U.S. biodefense capabilities. Efforts in MVA vaccine design and manufacturing improvements align with key recommendations from the recent "Bolstering U.S. Biodefense: Recommendations For The New Administration" report, published by the Janne E. Nolan Center on Strategic Weapons at the Council on Strategic Risks, a respected think tank specializing in national security and biodefense policy. The report emphasizes the need for robust, diversified medical countermeasures to protect national and global security.
Addressing Biodefense Gaps with MVA-Based Solutions
The "Bolstering U.S. Biodefense" report highlights the urgency of strengthening U.S. preparedness against biological threats, including deliberate attacks, emerging infectious diseases, and supply chain vulnerabilities. GeoVax's efforts towards the development of MVA-based vaccines, including GEO-MVA for vaccination against Mpox and smallpox, and efforts to transition to a next-generation manufacturing platform utilizing a continuous avian cell line, directly align with these national security objectives:
Vaccine Supply Chain Resilience: Current reliance on a single non-U.S. manufacturer for critical vaccines, such as MVA, poses a national security risk. GeoVax's efforts to transition to a next generation manufacturing platform should allow for the use of existing domestic manufacturing facilities, leading to a reduced dependence on foreign suppliers and enhancing supply chain security.
Advanced Biomanufacturing for Scalability: The biodefense report calls for investment in next-generation biomanufacturing. GeoVax is developing a continuous cell line-based MVA manufacturing platform that it expects will result in rapid, high-volume vaccine production, which is currently not feasible utilizing existing MVA directed manufacturing platforms
Diverse Medical Countermeasures for Threat Readiness: The Department of Defense's Biodefense Posture Review and National Biodefense Strategy emphasize the need for multiple vaccine approaches. GeoVax's MVA platform complements mRNA and protein-based vaccines, ensuring a broader and more resilient national preparedness framework.
Strategic National Stockpile Shortfalls: The 2022 Mpox epidemic revealed significant vaccine shortages in the National Strategic Stockpile, leaving public health officials unable to meet urgent demand. The reliance on a single foreign supplier for any vaccine can further exacerbate these challenges, reinforcing the need for a diversified, U.S.-based vaccine supply.
Relevance to the New HHS Administration
The transition of leadership at the U.S. Department of Health and Human Services (HHS) presents a pivotal moment for vaccine policy and national preparedness. The Administration has emphasized transparency, safety, and domestic vaccine manufacturing, aligning closely with GeoVax's mission.
Alignment with National Health Security Goals: GeoVax's focus on U.S.-based vaccine production supports HHS's priority of reducing dependency on foreign pharmaceutical supply chains, ensuring America's self-sufficiency in pandemic preparedness.
Advancing a Diversified Vaccine Portfolio: With a growing consensus that a single vaccine platform is unable to address the breadth of infectious disease concerns, there is a clear recognition of the benefits of having multiple alternative vaccine platforms available. GeoVax's MVA-based approach provides a proven, durable, and safe alternative, reinforcing a well-rounded immunization strategy.
Public Trust and Transparency: Given the call for increased scrutiny of vaccine development, GeoVax is committed to transparency, publishing full clinical trial results and working collaboratively with HHS to foster public confidence.
Policy Action to Strengthen U.S. Biodefense
GeoVax urges policymakers to act swiftly in supporting domestic vaccine production and biodefense innovation. Key recommendations include:
Expanding Federal Investment in MVA-Based Vaccines: Increased funding from BARDA, the Department of Defense, and the NIH to accelerate the development, next-generation manufacturing scale up and deployment of GEO-MVA.
Accelerating Regulatory Approvals: Streamlined pathways for emergency use authorization and priority review of MVA-based vaccines to strengthen national preparedness.
Public-Private Partnerships: Enhanced collaboration between government agencies, biotechnology firms, and global health organizations to integrate MVA-based solutions into pandemic and biodefense planning.
A Call for Action
"The 'Bolstering U.S. Biodefense' report clearly articulates the vulnerabilities in our national health security framework. GeoVax is committed to helping address these gaps with our MVA-based vaccines and next-generation manufacturing capabilities," said David Dodd, Chairman & CEO of GeoVax. "With a new HHS administration, there is a timely opportunity to strengthen domestic vaccine infrastructure and ensure greater national resilience against emerging threats."
GeoVax remains dedicated to advancing innovative, scalable, and accessible vaccine solutions to safeguard public health and national security.
References: Council on Strategic Risks. (2025). Bolstering U.S. Biodefense: Strengthening the Nation's Response to Biological Threats. Janne E. Nolan Center on Strategic Weapons. Retrieved from https://www.councilonstrategicrisks.org.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel vaccines for many of the world's most threatening infectious diseases and therapies for solid tumor cancers. The company's lead clinical program is GEO-CM04S1, a next-generation COVID-19 vaccine for which GeoVax was recently awarded a BARDA-funded contract to sponsor a 10,000-participant Phase 2b clinical trial to evaluate the efficacy of GEO-CM04S1 versus an approved COVID-19 vaccine. In addition, GEO-CM04S1 is 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(R), having recently completed a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. A Phase 2 clinical trial in first recurrent head and neck cancer, evaluating Gedeptin(R) combined with an immune checkpoint inhibitor is planned. GeoVax has a strong IP portfolio in support of its technologies and product candidates, holding worldwide rights for its technologies and products. The Company has a leadership team who have driven significant value creation across multiple life science companies over the past several decades. 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.
