離開
進入《TAIPEI TIMES》 CECC starts vaccine trial recruitement initiative
An online application form for participating in COVID-19 vaccine trials is displayed on the Taiwan Food and Drug Administration Web site yesterday. Screengrab from the Taiwan Food and Drug Administration Web site
PHASE 2: Eligible for participation in vaccine trials of three domestic firms would be adults above 20 and adolescents with parental consent, the agency said
By Lee I-chia / Staff reporter
The Central Epidemic Command Center （CECC） yesterday launched an online platform to recruit participants for COVID-19 vaccine clinical trials, the center said yesterday, adding that people can sign up until Nov. 30.
Minister of Health and Welfare Chen Shih-chung （陳時中）, who heads the center, said that the three domestic manufacturers that are developing COVID-19 vaccine candidates would soon complete phase 1 clinical trials.
“Phase 2 vaccine trials need relatively more participants,” he said, adding that the CECC launched the platform to help shorten the recruitment process and speed up the trials.
Food and Drug Administration （FDA） Director-General Wu Shou-mei （吳秀梅） said that each firm would need more than 3,500 participants for the phase 2 trials, including 3,000 in the experimental group, who would receive vaccine doses, and 500 in the control group, who would receive a placebo.
“However, not everyone who registers on the platform will become a participant, as the firms will make assessments,” Wu said, adding that the FDA hopes to receive applications from at least 20,000 volunteers.
“Participants can at any time of the trial opt out,” Wu added.
Eligible for enrolling are adults aged 20 or above, and adolescents aged 12 to 20 with the consent of their parents or a legally authorized representative, she said.
Wu said that people with at least one of five conditions are not recommended to participate: Those with chronic diseases or unstable health conditions; those with compromised immune systems or autoimmune diseases; those who have had a major surgery in the past month; those undergoing cancer treatment; and women who are pregnant, breastfeeding or planning to conceive.
Foreign residents are also eligible, FDA medicine section deputy head Wu Ming-mei （吳明美） said, adding that the agency would provide an English-language version of the consent form later this week.
Participants in vaccine trials usually receive an allowance for traveling to and from hospitals, and nutrition allowances, CECC specialist advisory panel convener Chang Shan-chwen （張上淳） said, adding that the companies would also provide compensation if an adverse event occurs, as participants would be insured through the companies.
Those who wish to participate in the vaccine trials can register at twcvt.fda.gov.tw/COVID19/index.aspx
In related news, Chen said that four imported cases of COVID-19 have been confirmed, three arriving from Indonesia and one from Belgium.
Cases Nos. 582, 584 and 585 are three Indonesian women, aged between 20 and 50, who arrived on Oct. 28 and have not experienced any symptoms, Chen said,
They stayed at centralized quarantine facilities and were administered COVID-19 tests on Monday before the end of their quarantines, Chen said, adding that the test results returned positive.
Case No. 583 is a Belgian in his 30s, who departed from the Netherlands on Oct. 24 and arrived in Taiwan a day later on a business trip at the invitation of a Taiwanese company, Chen said, adding that the man stayed at a quarantine hotel after arrival.
The man on Oct. 31 experienced abnormal sense of smell, but did not report it as the symptom eased the following day, and he moved to another hotel for self-health management after ending quarantine on Monday, Chen said.
The company asked him to get tested on Tuesday, and the result returned positive, Chen said.
In other news, as the number of locally transmitted COVID-19 cases reported in South Korea have been continuously growing, the center has removed the nation from the list of medium-low infection risk countries, from which short-term business travelers can apply for shortened quarantine periods, he said.
In addition, Chen confirmed that the CECC has given its approval for allowing “economic travel bubble” visits, the first in Taiwan since the pandemic started.
The Ministry of Economic Affairs on Tuesday said that a US electronics manufacturer would be the first company of whom a group of up to nine employees would be allowed to visit Taiwan under an “economic bubble,” exempting them from quarantine requirements given they provide negative COVID-19 test results.
Chen said that such visits would only be allowed by the CECC in cases of great importance and that the ministry would have to provide details on how visitors would be separated from the local population.
Additional reporting by CNA
新聞來源：TAIPEI TIMES
