A former top disease control official has urged the government to issue emergency use authorizations (EUAs) to speed up the development of COVID-19 vaccine candidates, saying that plans to hold clinical trials before the end of the year are “simply too slow.”
Taiwan needs to take steps to accelerate the domestic development of a vaccine, because it might not have immediate access when one is discovered abroad, given the intensity of global demand, said Su Ih-jen (蘇益仁), former Centers for Disease Control director.
More than 100 COVID-19 vaccine candidates are in development worldwide, 18 of which have entered human trials as of July 2, according to the WHO.
The US, Europe and China are making the fastest progress and have said a vaccine could reach the market by the end of the year.
In Taiwan, only two firms have submitted applications for clinical trials, while a third is expected to do so this month, the Central Epidemic Command Center said.
The National Health Research Institutes (NHRI) said that it hopes to have a vaccine candidate enter clinical trials by late this year.
Su said that Taiwan should follow the US and European countries and expedite vaccine development by issuing emergency authorizations, which shorten the regulatory approval process or allow human trials to proceeds while an application is under review.
Governments in the US and Europe are working as partners in developing a vaccine, rather than solely as regulators, and have been responding quickly to developers’ issues, Su added.
NHRI president Liang Kung-yee (梁賡義) said that the institute is in talks with the Ministry of Health and Welfare and the Taiwan Food and Drug Administration.
They are discussing vaccine authorization guidelines, based on those in the US, which would allow the NHRI to carry out certain regulatory, testing and production procedures concurrently, Liang said.
Under the plan, phase I clinical trials, which involve testing a drug on a small number of healthy volunteers, could be held simultaneously with toxicity testing as early as this month, Liang said.
Phase II testing — for efficacy and side effects — and mass production could also start at the same time, before the end of the year, while phase III testing, which involves larger-scale efficacy tests, could be completed by next April or May, Liang said.
In related news, CECC spokesman Chuang Jen-hsiang (莊人祥) yesterday said that the Filipino woman who tested positive for COVID-19 in Hong Kong after transiting through Taiwan on Friday was probably infected in the Philippines, not in Taiwan.
The woman flew from Manila to Taiwan, then transferred to a flight to Hong Kong, where on Saturday she was confirmed to have contracted COVID-19, Chuang said.
It is “absolutely impossible” for the passenger to have contracted the virus in Taiwan, as she had only spent a few hours at the airport, Chuang said, adding that it is impossible to test positive for COVID-19 hours after exposure to the virus.
Given that she tested positive a day after her arrival in Hong Kong, she was probably infected in the Philippines, he said.
The CECC would wait for Hong Kong to provide relevant information about the passenger, and assess the scope of her interactions with Taiwanese, before deciding how many people should be added to the center’s watch list, he said.
Additional reporting by Lin Hui-chin
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