GeoVax Advances Mpox and Smallpox Vaccine Toward Phase 3 Trial with Clinical Supply Milestone

GeoVax Labs, Inc. has announced that clinical supplies for its GEO-MVA vaccine program have completed required release testing, with final product release scheduled for early April. This milestone supports the company’s planned pivotal Phase 3 clinical study targeting protection against mpox and smallpox.

The availability of GEO-MVA clinical material advances the program toward an immune bridging study designed in accordance with guidance from the European Medicines Agency. This study, scheduled to initiate in the second half of this year, represents a critical step toward potential regulatory Marketing Authorization under the EMA’s expedited development pathway. The planned study aims to demonstrate comparability to an approved MVA vaccine using immunological endpoints.

‘The availability of GEO-MVA cGMP clinical material marks a significant advancement for the GEO-MVA program,’ said David Dodd, Chairman and Chief Executive Officer of GeoVax. ‘With final product release expected shortly, we are entering the final preparatory phase ahead of initiating our immune bridging study positioning GeoVax at a pivotal inflection point, moving toward potential regulatory approval and subsequent commercialization.’

Parallel to clinical progress, GeoVax has initiated outreach discussions supporting potential procurement and preparedness contracting. These discussions include organizations that influence or directly procure vaccines for national stockpiles, military preparedness programs, and international outbreak response initiatives. ‘We are encouraged by the early engagement with global health and preparedness stakeholders,’ Dodd added. ‘These discussions, alongside our clinical progress, underscore the increasing recognition of the critical need to expand global supply of MVA-based vaccines.’

The GEO-MVA program addresses a significant 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 with 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.

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 more information about the company’s development programs, visit https://www.geovax.com.

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