GeoVax Labs, Inc. (Nasdaq: GOVX) announced a Memorandum of Agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) on September 14, 2026, granting GeoVax access to the CEPI Centralised Laboratory Network for clinical trial sample testing in support of its planned pivotal Phase 3 immune-bridging study of GEO-MVA, an MVA-based vaccine candidate targeting mpox and smallpox. The agreement marks a significant step in the vaccine's development and could have far-reaching implications for global health security.
The CEPI Centralised Laboratory Network is the largest global group of laboratories dedicated to harmonizing the immunological assessment of vaccines against infectious diseases with epidemic and pandemic potential. By using standardized assays and reporting procedures, the network minimizes variability in trial readouts, helping researchers and regulators consistently evaluate vaccine performance. For GeoVax, this independent evaluation is crucial to build confidence in GEO-MVA among regulators, public-health organizations, governments, and potential strategic partners. As David Dodd, Chairman and CEO of GeoVax, stated, "Independent evaluation is an important step toward building confidence in GEO-MVA among regulators, public-health organizations, governments and potential strategic partners."
The agreement also supports a broader strategic objective: establishing GEO-MVA as an additional qualified source of MVA-based mpox vaccine supply. Recent global mpox outbreaks have underscored the risks of constrained vaccine supply and the importance of expanding MVA vaccine capacity. GeoVax believes that sustainable preparedness requires not only adequate vaccine stockpiles but also multiple qualified sources of supply and manufacturing capacity capable of serving different regions. Dodd continued, "But the larger objective extends beyond development of another mpox vaccine. The global preparedness community needs resilient MVA supply. We believe that the data produced by CEPI’s network could pave the way for an additional qualified supply source of mpox vaccine supply if we are successful in testing and licensure, reducing dependence on a single manufacturing infrastructure and ultimately enabling production capacity that can be deployed closer to the populations it is intended to protect."
Under the agreement, clinical samples from GeoVax will be evaluated using assays specific to orthopoxviruses, the family to which mpox and smallpox belong. The independent nature of the testing is particularly important as GeoVax advances GEO-MVA toward its pivotal Phase 3 study. Results generated through CEPI’s laboratory network will provide independently generated and standardized immunological data to inform GeoVax’s clinical development and future regulatory interactions. Dr Amy Shurtleff, Director of Laboratory Research and Innovation Department at CEPI, commented, "CEPI’s Centralised Laboratory Network was set up during the COVID-19 pandemic to help reduce clinical testing differences that can emerge from independent laboratory review to instead ensure easy access and alignment to key data that could support vaccine approvals. It has rapidly expanded since then, with vaccine developers around the world using the service to evaluate thousands of their samples produced during trials of promising vaccine candidates against other deadly pathogens, including mpox. Our new agreement with GeoVax enables the company to access validated, high-quality mpox testing tools that could fast-track its promising GEO-MVA mpox vaccine through development and give the world further options to fight this harmful, recurring disease."
The agreement also provides a framework for CEPI to share anonymized summaries of sample-testing results with the World Health Organization (WHO), Gavi, the Vaccine Alliance, and others to further CEPI’s mission. GeoVax will cover the full testing costs, and CEPI has not provided specific funding for GEO-MVA development. GeoVax expects to initiate the approximately 500-participant Phase 3 immune-bridging study in the fourth quarter of 2026, with results expected in mid-2027. The study follows Scientific Advice from the European Medicines Agency (EMA) and aims to compare immune responses generated by GEO-MVA with those of the licensed MVA-BN comparator.
This collaboration matters because it could accelerate the availability of a second MVA-based mpox vaccine, reducing reliance on a single manufacturer and enhancing global preparedness. The independent validation through CEPI’s network may also streamline regulatory pathways and bolster confidence in GEO-MVA, potentially leading to a more resilient vaccine supply chain. For more information about GeoVax, visit www.geovax.com. To learn more about CEPI and its Centralised Laboratory Network, visit CEPI.net.
