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# FDA OKs Resumption of Inovio Covid Vaccine Trial
- URL: https://www.fdaweb.com/fda-oks-resumption-of-inovio-covid-vaccine-trial/
- Published: 2021-11-10T12:00:00.000Z
- Updated: 2026-09-14T17:22:04.000Z
- Author: David McFarland
- Tags: Biologics, Devices, #legacy-id-D5150550

FDA has authorized Inovio to proceed with the INNOVATE Phase 3 segment for its INO-4800 Covid-19 vaccine candidate. In authorizing the trial, FDA lifted a partial clinical hold after reviewing additional non-clinical, clinical, and device information submitted by the company.

Inovio [says](https://ir.inovio.com/news-releases/news-releases-details/2021/INOVIO-Receives-U.S.-FDA-Authorization-to-Proceed-with-INNOVATE-Phase-3-Segment-for-its-COVID-19-Vaccine-Candidate-INO-4800-in-the-U.S/default.aspx?ref=fdaweb.com) the vaccine candidate is composed of a precisely designed DNA plasmid that is injected intradermally followed by electroporation using a proprietary smart device that delivers the DNA plasmid directly into cells in the body and is intended to produce a well-tolerated immune response.

The company is partnering with Advaccine Biopharmaceuticals Suzhou to conduct the INNOVATE Phase 3 segment in multiple countries in the Americas, Asia, and Africa to evaluate the vaccine’s efficacy in a two-dose regimen administered one month apart in men and non-pregnant women age 18 and older.