GeoVax Advances GEO-MVA Vaccine Program Toward Pivotal Phase 3 Trial

GeoVax Labs, Inc. has provided a development update on its GEO-MVA vaccine program for protection against mpox and smallpox, highlighting continued progress toward initiation of its planned pivotal Phase 3 clinical study. The company announced that GEO-MVA clinical supplies have completed required release testing, with final release of the product for clinical use scheduled for early April. Upon final release, sufficient clinical material will be available to fully support the planned immune bridging study designed in accordance with guidance from the European Medicines Agency (EMA).

This impending availability of GEO-MVA vaccine clinical material further advances the program toward initiation of the immune bridging study, a critical step toward regulatory Marketing Authorization under the EMA's expedited development pathway, scheduled to initiate in the second-half of this year. David Dodd, Chairman and Chief Executive Officer of GeoVax, stated that the availability of GEO-MVA cGMP clinical material marks a significant advancement for the program, positioning GeoVax at a pivotal inflection point moving toward potential regulatory approval and subsequent commercialization.

The planned immune bridging study is designed to demonstrate comparability to an approved MVA vaccine using immunological endpoints, consistent with EMA guidance supporting a streamlined development pathway. As recently announced, the company has initiated outreach discussions in support of potential procurement and preparedness contracting, positioning for rapid GEO-MVA vaccine distribution upon regulatory and/or Emergency Use Licensing issuance. These discussions include organizations that influence or directly procure vaccines for national stockpiles, military preparedness programs, and international outbreak response initiatives.

GEO-MVA is being developed to address a significant and well-recognized gap in global vaccine preparedness. Recent mpox outbreaks and evolving epidemiological patterns have reinforced the need for sustained preparedness, including expanded manufacturing capacity and diversified supply sources. The current supply of MVA vaccine is concentrated in a single commercial manufacturer, limiting redundancy in a platform considered essential for protection against both mpox and smallpox. GeoVax believes GEO-MVA has the potential to serve as an important additional source of MVA vaccine supply supporting national stockpile programs, global outbreak response efforts, and military and biodefense preparedness initiatives.

The GEO-MVA program is advancing under an expedited regulatory pathway supported by EMA scientific advice, which enables potential regulatory approval based on a single immune bridging study demonstrating non-inferiority to an approved MVA vaccine. Following successful completion of the planned study, GEO-MVA is expected to advance toward regulatory submission and potential commercialization as an additional source of MVA vaccine supply for global preparedness and biodefense programs. For more information about GeoVax's broader pipeline and development priorities, visit https://www.geovax.com.