Liu Hongen said that many of the disputes over Taiwan's self-produced vaccines in the past year are due to the non-public and opaque operating methods and standards, as well as the continuous rolling and even floating review standards and candidates for expert meetings, as well as various doubts and credibility caused by the loss of partial support publicity. (Data photo of Taiwan's "China Times Electronic News")
Taiwan's self-produced high-end vaccine has passed the EUA (emergency user license). The health and welfare department of the Taiwan authorities also allows high-end projects to be produced. Associate Professor of the Department of Law of Taiwan University of Political Science and the Health and Welfare Department and member of the Human Research Ethics Review Committee of the Health and Welfare Department "Disease Management Department" said on Facebook on the 19th that the outside world is full of doubts about the fact that the high-end vaccine has not yet been tested for the third phase. EUA should attach conditions and deadlines when licensing it. It also points out that the dispute over self-produced vaccines comes from many non-public and opaque operating methods and standards, which have caused harm to the credibility of the competent authorities.
Liu Hongen pointed out that the high-end vaccine EUA has passed, but since it is approved by the EUA emergency authorization project, it is based on the emergency public health needs. The outside world is full of doubts about it not yet undergoing the third phase test. Should the Food and Drug Administration only allow one short-term approval period, or complete the third phase test within a certain period of time to apply for a drug certificate, and the conditions are attached when the emergency needs are over, this approval can be abolished?
Liu Hongen pointed out that the press release of the Taiwan Health and Welfare Department did not specify how long the approval period is, whether to apply for a drug certificate within a time limit, nor did he specify whether he would attach any abolition conditions. In the vaccine EUAs in countries and regions around the world, the Taiwan authorities have adopted an extremely rare and special approach to approving the EUA, which can be approved by the EUA in a phase two trial (even without completing the phase two) and has aroused many doubts from all walks of life in advance. Therefore, the conditions and period for licensing should be more important.
In addition, the so-called "inspection and delivery to the island for implementation of vaccine protection benefits report within one year" is to require manufacturers to report what content and the projects and standards to evaluate vaccine protection benefits. These should also be formulated and announced in advance so that manufacturers can follow suit and allow all sectors of society to inspect. It should not be like a high-end press conference, and the Taiwan authorities temporarily announced an EUA standard only a few hours ago.
Liu Hongen said that many of the disputes over self-produced vaccines in the past year are due to the non-public and opaque operating methods and standards, as well as the continuous rolling and even floating review standards and candidates for expert meetings, as well as various doubts and credibility caused by the loss of partial support and publicity. I hope that the competent authorities will not repeat the same mistakes and continue to implement measures that self-righteously assist the Taiwan industry but actually help to harm the biotech industry. At this moment, we should try to rebuild the outside world's trust in the independent and objective status of the competent authorities and the reviewers.
