TAIPEI (Taiwan News) — Taiwan's Food and Drug Administration (FDA) announced Friday (Aug. 28) that it has conditionally approved United Biomedical, Inc., Asia (UBI Asia, 聯亞生技) starting clinical trials for its coronavirus vaccine — the second Taiwanese-made vaccine to enter the human testing phase.
After Taiwan vaccine maker Adimmune Corporation (國光生技) was given the green light to begin Phase I clinical trials for its vaccine candidate, AdimrSC-2f vaccine (COVID-19 S-protein) last week, UBI Asia was given permission to start human trials for its UB-612 vaccine after obtaining official notice from the FDA. The FDA said the notice should arrive in the next few days and the company can utilize the waiting period to select qualified subjects.
FDA Deputy Division Chief Wu Ming-mei (吳明美) explained that local health experts approved UBI Asia's human trials with certain conditions. She said UBI Asia has promised to supplement additional technical documents before it begins administering vaccines.
Wu pointed out that a few subjects have already received Adimmune's vaccine since Phase I began. Also, another company, Medigen Vaccine Biologics Corp. (MVC, 高端疫苗), is expected to receive approval for human trials soon.
Meanwhile, neither the National Health Research Institutes (NHRI) nor Enimmune Corp. (安特羅) have filed applications for the approval of human trials for their vaccines, she said, according to CNA.