TAIPEI (Taiwan News) — A vaccine for the Wuhan coronavirus (COVID-19) developed by Taiwanese vaccine maker Adimmune Corporation (國光生技) was on Monday (Aug. 17) given the green light for clinical trials by Taiwan's Food and Drug Administration (FDA), the first Taiwanese-made vaccine to enter the human testing phase.
On Monday afternoon, the FDA issued a press release announcing that it had recently held an expert meeting to review Adimmune Corp.'s vaccine candidate AdimrSC-2f vaccine (COVID-19 S-protein) for a Phase I clinical trial. The conclusion of the meeting was to approve the vaccine for human trials, with certain conditions and the caveat that the effectiveness of the vaccine will be decided after further evaluation of the trial results.
Chang Lien-cheng (張連成), head of the FDA's Medicinal Products Division, said experts at the meeting suggested that the first phase of Adimmune's clinical trial plan should be approved conditionally, reported CNA. Adimmune can first select qualified subjects, and after a review of data and approval by the Ministry of Health and Welfare, the vaccines can then be administered.
Chang said the Phase I human trials for the vaccine are expected to include 68 healthy subjects. Safety and toxicity tests will be carried out first before the vaccines are administered at the National Taiwan University Hospital.
The company is expected to receive NT$200 million (US$6.8 million) in government subsidies for entering the first phase of clinical trials in late August, reported UDN. If it gets approval to begin Phase II before Dec. 31, the company will receive an additional NT$300 million.
Chang said applications from other manufacturers are still under review but that Adimmune's product is the first in Taiwan to be allowed to enter human trials.