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September 29, 2020

Health Law Daily

FDA Pauses Inovio Pharmaceuticals’ Plan To Start Phase 2/3 Trial For Coronavirus Vaccine

  • September 29, 2020

Reuters (9/28, Mishra) reports the FDA “has put a hold on Inovio Pharmaceuticals Inc’s plans to start final trials of its coronavirus vaccine as the agency seeks more information, including details on a delivery device used to inject genetic material into cells.” The company’s phase 2/3 trials “were scheduled to start this month after they were postponed from this summer.” Inovio “said on Monday the latest delay due to the FDA’s ‘partial clinical hold’ was not due to any side effects in the early-stage study of the vaccine, which was continuing.”
      The Wall Street Journal (9/28, Hopkins, Subscription Publication) reports the study will be delayed until October at least.
      Also reporting are Bloomberg (9/28, Lauerman, Flanagan), BioPharma Dive (9/28, Gardner), and Bioworld (9/28).