GeoVax Accelerates Mpox Vaccine Development Amid New Variant Concerns

The identification of a newly evolved recombinant Mpox strain by UK health authorities has brought renewed attention to viral evolution and global vaccine supply vulnerabilities. GeoVax Labs, Inc. addressed these developments, emphasizing how its GEO-MVA vaccine program represents a strategic response to both public health and national security concerns. Early analysis indicates the variant contains genetic elements from both Clade I and Clade II Mpox viruses, which could impact disease severity, transmissibility, and vaccine effectiveness.

This discovery occurs while global Mpox vaccine supply remains concentrated with a single manufacturer, creating significant risks for preparedness, surge capacity, and equitable access. GeoVax's GEO-MVA program aims to develop an expanded supply of Modified Vaccinia Ankara (MVA)-based vaccine to bolster both domestic and global resilience. The company highlights that simultaneous circulation of multiple Mpox clades creates ongoing risk for recombination and changing outbreak behavior, while the single-vendor global supply model heightens vulnerability for stockpile readiness and distribution.

GeoVax is progressing GEO-MVA as the first U.S.-based Mpox/smallpox vaccine, aiming to deliver a scalable, domestically manufactured solution that supports national biodefense and global supply diversification. Final fill-finish manufacturing activities are scheduled for completion by year-end, with first-in-human studies planned upon regulatory clearance. David Dodd, Chairman & CEO of GeoVax, stated that viral evolution continues unabated and that dependence on a single global provider creates clear risks to preparedness, national security, and market stability.

Significant regulatory momentum has accelerated the program's timeline. GeoVax recently 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 requiring Phase 1 or Phase 2 trials to support a Marketing Authorization Application for GEO-MVA. The EMA's Committee for Medicinal Products for Human Use also affirmed the adequacy of GeoVax's proposed nonclinical package and agreed with the company's immunogenicity endpoints for demonstrating non-inferiority to licensed comparator vaccines.

This guidance provides substantial acceleration of the regulatory timeline, a de-risked development path, and potentially earlier commercialization across all 27 EU member states. The EMA's pathway positions GeoVax for expedited approval, reduced development costs, and earlier revenue generation as the company advances GEO-MVA toward Phase 3. The vaccine is engineered to provide durable, broad immune response with both civilian and biodefense dual-use applicability, featuring U.S.-based manufacturing to reduce foreign supplier reliance.

GeoVax's planned transition to AGE1 continuous cell-line manufacturing is expected to expand output, reduce costs, and support global self-sufficiency. The company's broader development portfolio includes other vaccine candidates, with more information available at https://www.geovax.com. The emergence of the recombinant Mpox variant underscores the ongoing need for diversified vaccine supply chains and accelerated development pathways to address evolving viral threats and strengthen global health security.