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GeoVax advances mpox vaccine program toward phase 3 study

March 25, 2026 9:21 AM

GeoVax Labs Inc. (NASDAQ: GOVX) announced that clinical supplies for its GEO-MVA vaccine have completed required release testing, with final product release scheduled for early April 2026.

The clinical-stage biotechnology company stated that sufficient clinical material will be available to support a planned immune bridging study designed according to European Medicines Agency guidance. The study is scheduled to begin in the second half of 2026.

"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."

The immune bridging study aims to demonstrate comparability to an approved MVA vaccine using immunological endpoints, following EMA guidance for a streamlined development pathway toward regulatory marketing authorization.

GeoVax reported it has initiated discussions with organizations involved in vaccine procurement for national stockpiles, military preparedness programs, and international outbreak response initiatives. The company is positioning for potential distribution upon regulatory or emergency use licensing approval.

The GEO-MVA vaccine is being developed for protection against mpox and smallpox. According to the company, current MVA vaccine supply is concentrated in a single commercial manufacturer, creating a supply gap that GEO-MVA could address for national stockpiles, outbreak response efforts, and military preparedness programs.

The information is based on a company press release statement.

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