COVID-19 vaccine clinical trials approvedANTIBODIES: Adimmune became the first in the nation to gain FDA approval to start phase 1 human tests, which it plans to commence by the end of this monthBy Kao Shih-ching / Staff reporterThe Food and Drug Administration (FDA) yesterday approved Adimmune Corp’s (國光生技) application to conduct phase I clinical trials of its COVID-19 candidate vaccine, making it the first in the nation to get the green light, the company said in a filing with the Taiwan Stock Exchange yesterday. The FDA on Monday granted Adimmune conditional approval for its clinical trial application, asking it to submit additional technical data. After complying with the request, the company received full approval yesterday, it said in a press release. Adimmune plans to enroll 60 to 70 healthy adult participants, who would be divided into three groups that would receive low, medium and high doses of the drug, Pan said. To speed up development of the vaccine, Adimmune intends to combine the phase II and phase III trials into a phase II/III design and run the final phase in November, subject to FDA approval, he said.

Source: Taipei Times August 20, 2020 15:56 UTC