Curated News
By: NewsRamp Editorial Staff
December 18, 2025
GeoVax Gains EMA Backing for Phase 3 Mpox/Smallpox Vaccine Trial
TLDR
- GeoVax's EMA alignment accelerates GEO-MVA's Phase 3 trial, potentially creating a competitive advantage in the Mpox/smallpox vaccine market by 2026.
- EMA's Scientific Advice confirms GeoVax can proceed directly to a single Phase 3 immunobridging study against Imvanex, streamlining the regulatory pathway to commercialization.
- GEO-MVA's development strengthens global vaccine supply diversification, enhancing preparedness against Mpox and smallpox threats for better public health protection worldwide.
- GeoVax's MVA-based vaccine candidate skips Phase 1/2 trials, moving straight to Phase 3 in 2026 following EMA's regulatory alignment on trial design.
Impact - Why it Matters
This regulatory milestone has significant implications for global public health preparedness. With mpox outbreaks continuing to occur worldwide and smallpox remaining a potential bioterrorism threat, vaccine diversification is crucial. Currently, global supply relies heavily on a single supplier, creating vulnerability in pandemic response systems. GeoVax's GEO-MVA vaccine, if successful, could provide an alternative option, enhancing supply chain resilience and potentially offering different storage, distribution, or efficacy characteristics. For healthcare systems and governments, this represents progress toward more robust preparedness frameworks. For the public, it means potentially broader access to protection against these diseases, particularly important for at-risk populations and regions with limited current vaccine availability. The EMA's endorsement also validates the immunobridging approach, which could streamline future vaccine development for other threats.
Summary
GeoVax Labs, a clinical-stage biotechnology company, has achieved a critical regulatory milestone by receiving formal Scientific Advice from the European Medicines Agency (EMA) for its GEO-MVA vaccine candidate. The EMA's concurrence confirms alignment on GeoVax's proposed pivotal Phase 3 immunobridging trial design, which will evaluate GEO-MVA against the approved MVA vaccine, Imvanex®, for the prevention of Mpox and smallpox. This regulatory green light allows the company to accelerate directly into a single, registrational Phase 3 study without needing additional Phase 1 or 2 trials, with initiation projected for the second half of 2026. The EMA's feedback validates that non-inferiority immunogenicity endpoints and the proposed clinical safety database are sufficient to support a future Marketing Authorization Application, assuming successful trial outcomes.
David Dodd, Chairman and CEO of GeoVax, emphasized that this formal Scientific Advice represents a pivotal step forward that meaningfully de-risks the regulatory path in Europe and moves GEO-MVA from a conceptual pathway to a clearly defined development plan. The milestone follows favorable preliminary EMA guidance announced in June 2025 and marks the transition from regulatory alignment to execution. This development strengthens GEO-MVA's profile as a potential solution to expand global vaccine supply beyond the current single-supplier paradigm, particularly as health authorities emphasize preparedness and diversification. For more information about the company's progress, visit www.geovax.com.
Beyond GEO-MVA, GeoVax's portfolio includes GEO-CM04S1, a next-generation COVID-19 vaccine in Phase 2 trials for immunocompromised patients and as a booster, and Gedeptin®, an oncolytic therapy for advanced head and neck cancers. The company's strong IP portfolio supports its technologies worldwide. This regulatory advancement positions GeoVax to potentially address critical public health needs through innovative vaccine development, with the original release available on www.newmediawire.com. The EMA's support underscores the growing importance of vaccine diversification and preparedness in global health strategy.
Source Statement
This curated news summary relied on content disributed by NewMediaWire. Read the original source here, GeoVax Gains EMA Backing for Phase 3 Mpox/Smallpox Vaccine Trial
