⁍ The U.S. health regulator has put a hold on Inovio Pharmaceuticals Inc’s plans to start final trials of its coronavirus vaccine.
⁍ Inovio said it would respond to FDA’s queries in October, after which the U.S. agency would have 30 days to decide whether the trial should proceed.
– The FDA has put a hold on mid-to-late trials of an experimental vaccine designed to fight the deadly strain of coronavirus, sending shares of Inovio Pharmaceuticals down as much as 25%, Reuters reports. The vaccine is being developed using Inovio’s DNA medicine platform, and was supposed to be administered through a device called Cellectra, which sends an electrical pulse to open a cell’s pores and allow DNA molecules to enter. But the FDA is now seeking more information on that device, and Inovio says it won’t be able to start the mid-to-late trials this month as planned. “It’s not guaranteed that Inovio will have the all-clear from the FDA to start the trial once it hears back from the agency in November,” an analyst says.
Source: https://www.reuters.com/article/health-coronavirus-inovio-pharma/update-3-us-fda-pauses-inovios-coronavirus-vaccine-trial-plan-idUSL4N2GP2HE