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FAQ: GeoVax's Response to New Mpox Variant and GEO-MVA Vaccine Program
TL;DR
GeoVax's GEO-MVA vaccine offers a strategic advantage by diversifying global Mpox vaccine supply away from a single manufacturer, reducing geopolitical risks and creating market opportunities.
GeoVax's GEO-MVA vaccine uses Modified Vaccinia Ankara technology to generate broad immune responses, with EMA-approved accelerated Phase 3 trials and U.S.-based manufacturing for scalable production.
GeoVax's domestic Mpox vaccine production addresses global supply vulnerabilities, potentially improving equitable access and pandemic preparedness for a safer tomorrow.
A new recombinant Mpox strain combining Clade I and II elements has emerged, highlighting viral evolution while GeoVax advances its vaccine with streamlined EMA approval.
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GeoVax is addressing reports of a newly evolved recombinant Mpox strain and highlighting how its GEO-MVA vaccine program responds to the risks posed by viral evolution and concentrated global vaccine supply.
UK health authorities have confirmed a newly evolved recombinant Mpox strain containing genetic elements from both Clade I and Clade II Mpox viruses, indicating ongoing viral evolution with potential implications for disease severity, transmissibility, and vaccine readiness.
Global Mpox vaccine supply remains concentrated with a single manufacturer, creating risks around preparedness, surge capacity, geopolitical access, stockpile readiness, and equitable vaccine distribution.
GEO-MVA is GeoVax's next-generation Modified Vaccinia Ankara (MVA)-based Mpox/smallpox vaccine being developed as the first U.S.-manufactured Mpox/smallpox vaccine, aiming to provide a scalable, domestically manufactured solution that supports national biodefense and global supply diversification.
GeoVax received positive Scientific Advice from the European Medicines Agency (EMA) confirming the company may proceed directly to a single Phase 3 immuno-bridging trial without Phase 1 or Phase 2 trials required for a Marketing Authorization Application, significantly accelerating the regulatory timeline.
Final fill-finish activities of GEO-MVA are scheduled to be completed by year-end (2025), with first-in-human studies planned upon regulatory clearance, and the EMA pathway positions the company for expedited approval and earlier commercialization across EU member states.
The recombinant strain highlights that viral evolution continues, simultaneous circulation of multiple Mpox clades creates ongoing recombination risk, and global dependence on a single vaccine supplier heightens vulnerability for preparedness, national security, and market stability.
GEO-MVA is engineered to provide a durable, broad immune response with both civilian and biodefense (dual-use) applicability, and it represents the first U.S.-based manufacturing pathway for Mpox/smallpox vaccine, reducing reliance on foreign suppliers.
David Dodd, Chairman & CEO of GeoVax, stated that the emergence of a recombinant Mpox strain is a timely reminder that viral evolution does not pause, and GEO-MVA is being developed to meet the strategic need for a U.S.-manufactured vaccine supporting both domestic requirements and global demand.
Curated from NewMediaWire
