FAQ on GeoVax's Accelerated Development of GEO-MVA Vaccine Amid Global Mpox Crisis

What is the GEO-MVA Mpox vaccine?

The GEO-MVA Mpox vaccine is a vaccine candidate being developed by GeoVax Labs, Inc. to combat the Mpox virus, with a focus on addressing the current global shortage and the emergence of more virulent strains.

Why is the development of the GEO-MVA Mpox vaccine being accelerated?

The acceleration is due to a record-setting surge in Mpox cases, especially in Africa, the WHO’s reaffirmation of Mpox as a global emergency, and favorable scientific advice from the EMA supporting an expedited development path.

How does the current Mpox outbreak compare to previous years?

In 2025, more than 21,000 confirmed Mpox cases have been reported in 13 African countries, exceeding the total case count for all of 2024, with numbers expected to double by year-end.

What are the challenges in combating the Mpox outbreak?

Challenges include critical vaccine shortages, the spread of more virulent Mpox strains (Clade I and Clade 1a), armed conflict, collapsing infrastructure, and significant reductions in U.S. and European aid.

What is the significance of the WHO’s reaffirmation of Mpox as a Public Health Emergency of International Concern (PHEIC)?

It underscores the worsening multi-country outbreak and the urgent need for global action to enhance surveillance, laboratory, and response systems to combat the spread of Mpox.

How is the GEO-MVA vaccine development being expedited?

GeoVax is finalizing fill-finish manufacturing, initiating human trials to evaluate safety and immunogenicity, and pursuing a streamlined regulatory pathway based on EMA’s favorable scientific advice for potential conditional approval.

Where are the most heavily impacted regions by the Mpox outbreak?

Sierra Leone, Malawi, and the Democratic Republic of the Congo (DRC) are among the most heavily impacted, with healthcare systems under severe strain due to the outbreak and aid reductions.

What are the implications of the EMA’s guidance for the GEO-MVA vaccine?

The EMA’s guidance supports a streamlined regulatory pathway for GEO-MVA, enabling expedited development and potential conditional approval in the EU, and strengthens its relevance to global procurement programs like those of WHO and UNICEF.