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FAQ: GeoVax's GEO-MVA Vaccine Fill-Finish Completion and Phase 3 Trial Timeline
TL;DR
GeoVax's GEO-MVA vaccine completion positions the company to capture market share by providing a domestic alternative to foreign MVA vaccines, strengthening U.S. biodefense independence.
GeoVax completed fill-finish manufacturing for GEO-MVA, entering final release evaluation before Phase 3 immunobridging trials in Q1 2026, following EMA's accelerated regulatory pathway.
GEO-MVA vaccine development enhances global pandemic preparedness by diversifying vaccine supply, reducing dependence on single sources, and improving health security against Mpox and smallpox threats.
GeoVax's GEO-MVA vaccine uses Modified Vaccinia Ankara technology to create a next-generation smallpox/Mpox vaccine, advancing through final quality checks before clinical trials begin.
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GeoVax Labs announced the successful completion of fill-finish for the initial clinical batch of GEO-MVA, its next-generation Mpox/smallpox vaccine, with the product now entering final release evaluation before clinical use.
GEO-MVA is a Modified Vaccinia Ankara (MVA)-based vaccine designed to protect against Mpox and smallpox, aiming to expand global vaccine availability and diversify manufacturing sources.
It addresses vulnerabilities from U.S. dependence on a single foreign MVA vaccine supplier by providing a domestically controlled second-source supply, strengthening biodefense infrastructure amid increasing global Mpox activity.
The vaccine is undergoing final release evaluation, which is the concluding quality-control and compliance process required before shipment for clinical use.
Phase 3 immunobridging trial start-up activities are positioned to begin in the first quarter (Q1) of 2026.
The European Medicines Agency (EMA) confirmed that a single Phase 3 immunobridging study showing immune comparability to the approved MVA vaccine Imvanex® would be sufficient for efficacy evaluation, providing an accelerated path to licensure.
GEO-MVA is designed to be comparable to the approved MVA vaccine Imvanex® through immunobridging studies, while offering a diversified, domestically manufactured supply alternative to reduce reliance on a sole foreign supplier.
GeoVax's broader MVA platform includes next-generation COVID-19 and other infectious disease programs, with lead clinical programs like GEO-CM04S1 (a COVID-19 vaccine) and Gedeptin® (an oncolytic solid tumor therapy).
David Dodd, Chairman & CEO of GeoVax, stated that this represents critical steps toward Phase 3 initiation and advances the mission to support U.S. and global health security by providing a domestically controlled second-source vaccine supply.
Curated from NewMediaWire
