Taiwan denies approval for UBI's COVID-19 vaccine candidate

TAIPEI (Reuters) – Taiwan has rejected an application for the production and emergency use of UBI Pharma Inc’s COVID-19 vaccine candidate, the government said on Monday, in a setback for the island’s push to attain self-sufficiency.

A medical worker disinfects the chairs after people received a dose of the AstraZeneca vaccine against the coronavirus disease (COVID-19) during a vaccination session for elderly people over 75 years old, at a stadium in New Taipei City, Taiwan June 25, 2021. REUTERS/Ann Wang

Developing its own vaccine has been a major goal, although Taiwan has also ordered millions of shots from Moderna Inc and AstraZeneca PLC, and is due next week to start injecting its first domestically-developed vaccine, made by Medigen Vaccine Biologics Corp.

The health ministry, explaining the rejection of the request for emergency use authorisation, or EUA, said the antibodies engendered by UBI’s vaccine candidate did not match up with those prompted by the AstraZeneca vaccine.

However, the ministry said, UBI planned Phase III trials in India.

Health Minister Chen Shih-chung expressed regret that the EUA had not been granted.

“We still have to follow certain standards,” he told reporters.

UBI did not immediately respond to a request for comment.

In June, the company had said it would seek an EUA in Taiwan and that Phase II tests showed no major adverse effects for its vaccine candidate, which, it said, generated a good immune response.

About 40% of Taiwan’s 23.5 million people have received at least one dose of the two required by the vaccine regimen.

However, unlike some other parts of Asia, Taiwan faces no huge pressure to vaccinate the populace.

The pandemic is well under control in Taiwan, with only a handful of domestic infections reported daily following tough controls adopted after a spike in cases that began in mid-May.

The government has drawn criticism from opposition parties after President Tsai Ing-wen pledged that month to start administering domestically developed vaccines in July, before results of second clinical trials were released.

Later, Tsai said Taiwan would strictly scrutinise the process according to global scientific norms and put safety first.

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