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進入《TAIPEI TIMES》 NPP calls for vaccine EUA transparency
Premier Su Tseng-chang, left, and Minister of Health and Welfare Chen Shih-chung, who heads the Central Epidemic Command Center, take part in a question-and-answer session at the Legislative Yuan in Taipei yesterday. Photo: CNA
PUBLIC TRUST: Disclosing the standards for granting emergency use authorization for locally developed vaccines would boost public confidence in them, the party said
By Shelley Shan / Staff reporter
The Food and Drug Administration （FDA） should disclose its standards for granting emergency use authorizations （EUA） for locally developed vaccines against COVID-19, the New Power Party （NPP） caucus said yesterday.
Last year, FDA officials said the agency would stipulate EUA guidelines for locally developed vaccines by consulting those adopted by the US Food and Drug Administration, the caucus said.
Minister of Health and Welfare Chen Shih-chung （陳時中）, who heads the Central Epidemic Command Center, on Tuesday last week said that the ministry would examine the results of double-blind studies of COVID-19 vaccines developed by Medigen Vaccine Biologics Corp and United Biomedical, and consult medical experts about the results before issuing any authorizations.
Medigen yesterday said it would soon finish compiling statistics gathered in its double-blind study, which would be reviewed and analyzed by members of an independent data monitoring committee.
Despite the progress in the development of local vaccines, most people are not clear about the FDA’s standards in approving EUA applications, the NPP caucus said, adding that Medigen, United Biomedicals and other COVID-19 vaccine developers should not be privy to such information.
Without publicly disclosing the standards, the FDA would inevitably be accused of using an opaque process so that local vaccines could be quickly approved, the party said.
Former Academia Sinica president Wong Chi-huey （翁啟惠） highlighted in a recent statement the importance of making public the EUA standards, review process and relevant statistics, it said.
National Chengchi University law professor Mark Liu （劉宏恩） has also asked about the criteria the FDA uses to approve vaccines produced by local pharmaceutical firms for emergency use.
When NPP legislators Claire Wang （王婉諭） and Chiu Hsien-chih （邱顯智） asked officials about the EUA standards, Chen and Premier Su Tseng-chang （蘇貞昌） avoided answering the questions directly and simply said that they would give EUA standards and relevant data to lawmakers, the party said.
“What we do not understand is why is it so difficult for the government to disclose the EUA standards for vaccines developed and produced in Taiwan. Transparency should be the No.1 priority in the nation’s disease prevention efforts; otherwise people would lose faith in locally produced vaccines,” the party said.
The US FDA published review standards for EUAs on Oct. 6 last year, it said, adding that vaccines developed by Pfizer-BioNTech and Moderna were subsequently approved for emergency use on Dec.11 and Dec. 18 last year.
The Institute for Biotechnology and Medicine Industry last week said that safety and efficacy were key factors in the administration of vaccines.
The government can use biomarkers recognized by the international medical community as a reference and stipulate its own EUA standards, such as results of antibody potency and cell-mediated immune response tests, it said.
新聞來源：TAIPEI TIMES
Wearing a protective suit, Chinese Nationalist Party （KMT） Legislator Jessica Chen takes part in a question-and-answer session at the Legislative Yuan in Taipei yesterday. Photo: CNA
