FDA considers NT$1bn for clinical trials of COVID-19 vaccines

ROC Central News Agency

07/07/2020 09:29 PM

Taipei, July 7 (CNA) Taiwan's government will formalize plans by the end of July to allocate NT$1 billion (US$33.9 million) to hold clinical trials of COVID-19 vaccine candidates with the goal of developing an effective vaccine by the first quarter of 2021, according to the head of the Food and Drug Administration (FDA).

In addition to the NT$1 billion in funding, the government is also considering allowing phase 2 and 3 clinical trials to be carried out concurrently with as few as 1,000 participants, FDA Director-General Wu Shou-mei (吳秀梅) said in a joint interview Tuesday.

The plans, which are still pending approval by the Executive Yuan, could allow a domestically-produced COVID-19 vaccine to reach the market by the first quarter of next year, she said.

Wu's remarks came after Su Ih-jen (蘇益仁), former director-general of the Bureau of Communicable Disease Control (the predecessor of the Centers for Disease Control), called on the government to issue emergency use authorizations (EUAs) to accelerate Taiwan's vaccine development process.

At a forum held by the National Health Research Institutes (NHRI) Tuesday, Su said a COVID-19 vaccine could be developed internationally as soon as October, as countries try to head off an expected surge in cases during the winter months.

According to Su, three developers in Taiwan have already made considerable progress toward a vaccine, but still face a lengthy and difficult path to approval.

If the developers begin clinical evaluations in August or September, and are doing large phase 2 tests with the legally-required 3,000 subjects by the end of the year, they would still have to hold phase 3 trials, and a vaccine could only be ready by February or March of next year, Su said.

To expedite the process, Su said the government should consider issuing EUAs, based on those being used internationally, to lower certain testing requirements, such as reducing the scale of phase 2 testing to 1,500 people.

"If Taiwan only focuses on safety it will not be able to speed up development," Su said, adding that a vaccine that comes too late will be of little use to the public.

When asked about Su's comments, Wu said Taiwan's epidemic prevention measures made a resurgence of COVID-19 in the winter unlikely, but said vaccine testing could be safely accelerated by reducing the number of participants in clinical trials.

(By Chang Ming-hsuan and Matthew Mazzetta)

Enditem/AW