Taiwan’s Food and Drug Administration (FDA) says that it might be late July before it can consider authorizing the country’s first locally made COVID-19 vaccine.
FDA Director General Wu Shou-mei said Monday that the vaccine manufacturer – Medigen – still needs to submit some technical documents. Without them, the FDA cannot move forward with the process for granting Emergency Use Authorization (EUA).
Medigen is the first pharmaceutical company in Taiwan to announce the results of phase II trials on a COVID-19 vaccine. The company submitted the vaccine for EUA approval on June 15, in the hopes of beginning mass production in July. But Wu says that more documents are needed, some of which require the assistance of third-party testing labs.
Meanwhile, a second Taiwanese pharmaceutical company – United Biomedical Inc. (UBI) – has held a press conference announcing the results of Phase II trials for a COVID-19 vaccine of their own. The company said on Sunday that their vaccine offers protection from COVID-19 variants. UBI is planning to conduct a phase III clinical trial involving 11,000 people in India. There are also plans to test the vaccine’s effectiveness when used in combination with other jabs.
FDA head Wu Shou-mei says that she has not yet seen the details of the UBI trials. She says that once the company submits them, an official review will take place.