21 August 2020 | News
The indigenous COVID-19 vaccine, "AdimrSC-2f vaccine (COVID-19 S-protein)" from Adimmune Corp. is the first to enter Phase I human trials in Taiwan with conditional approval from Taiwan FDA
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For the first time ever, Taiwan's Food and Drug Administration (FDA) has given conditional approval for the experimental COVID-19 vaccine developed by Taiwanese company 'Adimmune Corporation' to initiate the human clinical trial.
The indigenous COVID-19 vaccine, "AdimrSC-2f vaccine (COVID-19 S-protein)" was found Sunday by medical experts to be eligible to enter a phase 1 clinical trial, under controlled policies of FDA.
Chang Lien-cheng, the head of the Medicinal Products Division at the FDA, said the company must first look for 60 able-bodied and healthy individuals for the trial. For safety reasons, the people chosen will have to undergo toxicity testing before the COVID-19 trial, which is expected to take place at National Taiwan University Hospital".
The Ministry of Health and Welfare is still waiting on the company to provide additional technical data about the vaccine, and only after the data is received can the process begin, he said.
According to the health official, if things move forward as scheduled, the vaccine by Adimmune would likely be the first to enter a clinical trial in the country.
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.