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# Inovio Covid-19 Vaccine Trial on Partial Hold
- URL: https://www.fdaweb.com/inovio-covid-19-vaccine-trial-on-partial-hold/
- Published: 2020-09-28T12:00:00.000Z
- Updated: 2026-09-14T16:30:32.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147741

FDA has placed a partial clinical hold on an Inovio planned Phase 2/3 trial of its Covid-19 vaccine candidate INO-4800, including its Cellectra 2000 delivery device to be used in the trial. The partial hold is not due to the occurrence of any adverse events related to the company’s ongoing expanded Phase 1 study of the vaccine, which may continue and is not impacted by the hold, according to Inovio. The company says it is actively working to address the agency’s questions and plans to respond next month.

Inovio says it is working with a team of contract manufacturers including Thermo Fisher Scientific, Richter-Helm BioLogics, and Ology Bioservices to manufacture INO-4800 on a commercial scale and is seeking additional external funding and partnerships to further scale up manufacturing capacities. Currently, the Coalition for Epidemic Preparedness Innovations, the Bill & Melinda Gates Foundation, and the U.S. Department of Defense have contributed significant funding to advance INO-4800.

INO-4800 is Inovio’s DNA vaccine candidate created to protect against Covid-19\. Interim Phase 1 results showed a favorable safety profile and strong immunogenicity, including antibody and T cell responses, the company says. It was designed using Inovio’s proprietary DNA medicine platform rapidly after the publication of the genetic Covid-19 sequence.