The epidemic on Taiwan’s island continues to expand, and the number of deaths and confirmed cases continues to rise. Former New Taipei Mayor Zhu Lilun shouted loudly: "It has been a year since the card was blocked, and the number of black epidemics should be exposed!" The antonym of "blocking the card" is "flop", which means showing the card publicly. Zhu Lilun directly asked the Tsai Ing-wen administration to put away the ostrich mentality. Concealing the epidemic is abomination, and what is even more terrifying is that the Tsai administration actually opposed science when it started to produce the new crown vaccine in Taiwan a year ago and decided to go public without the need for a phase 3 clinical trial.
Zhu Lilun said on Facebook that in the past year, no matter how many outside experts call and how the people demand it, the "Command Center" has always been unwilling to include "wide screening" in the focus of epidemic prevention, and the reasons are strange: false negative, false positive, insufficient cost, wasted public funds, overseas epidemics have increased instead of reducing, and consuming medical human resources, etc. However, the command center has quietly changed its attitude recently.
Zhu Lilun believes that the current severe mortality rate and mortality rate of Taiwan's current epidemic are higher than the world average. The big reason may be that the number of confirmed cases is seriously underestimated and there is a "black number of epidemics".
, while Taiwan's "New News" published a famous article, exposed Taiwan's " Disease Control Department " plan, and Taiwan-made vaccines decided not to do the third phase last year, and then went on the market after the second phase was secretly taken.
The article signed by Huang Tianru said that many people thought the epidemic on the island was coming suddenly and the arrival of imported vaccines was blocked, so the government had to consider issuing the domestic vaccine EUA (emergency user license) to be launched at the end of July.
In fact, as early as mid-last year when the Taiwan-made vaccine started, the "Supplement-Donation of the COVID-19 Vaccine Plan" issued by the Department of Disease Control and Prevention of the COVID-19 Vaccine Plan" laid the foreshadowing of the second phase of human clinical trials for vaccines produced by the Food and Drug Administration (TFDA) at the end of last year, and even claimed to refer to the guidance of the US Food and Drug Administration (FDA). As long as the number of people with Phase II of the Taiwan-made vaccines tested for more than 3,000, and the unblinding shows that the vaccine immunogenicity is good, it can be launched for vaccination.
However, the U.S. Emergency User License requires 3,000 people in the third phase of the trial, rather than 3,000 people in the second phase of the trial, which is very different. The article said that this can be proved that long before the outbreak of the local epidemic, the authorities and vaccine operators were determined to receive a Taiwanese vaccine that only completed the second phase of the human clinical trial. The article
revealed that the Taiwan authorities have always tended toward . "The epidemic is urgent, and the development of vaccines is a race against time. If Taiwan-made vaccines can complete the expansion of the second phase of clinical trials and go to the market early, isn't that a good thing?" The article
article revealed that the WHO (WHO) discussed whether it could directly infer the correlation between vaccine protective power on the serum antibody concentration of vaccine subjects as early as the outbreak of new coronary pneumonia in March last year, and to solve the problem of shortage of vaccines. However, there are many experts and opponents. 's reason is that this can only "infer" the effectiveness of the vaccine, and there are various variables such as laboratory methods in the inference process, such as difficulty in unifying the patient's method; and the purpose of the traditional third phase of human clinical trial is to ensure the safety and effectiveness of the vaccine. Without doing so, it is obviously impossible to ensure the most important effectiveness of the vaccine. Chen Jianwei, director of the Human Clinical Trial Center of National Taiwan University Hospital, who attended the meeting, later publicly stated that this practice was not officially listed in the reference criteria for the human clinical trial of new coronary pneumonia vaccine .
The article ended with saying that many people think that the local epidemic came suddenly and deteriorated rapidly, resulting in insufficient vaccines. forced the authorities to consider allowing the two Taiwanese-made vaccines to obtain EUA after completing the second phase of human clinical trials at the end of July and then go to the market as soon as possible.
But the fact is that as early as July 2020, when the CDC formulated the "Supplement donation plan for civil groups to develop COVID-19 vaccines", it was clear that Taiwanese-made vaccines started too slowly and their R&D strength was difficult to go hand in hand with multinational manufacturers. It is likely that the third phase of human clinical trials must be completed step by step. Therefore, in addition to the general first and second phase human clinical trial specification (the number of subjects in the first phase is 40 to 60, the second phase is 1,300, and the third phase is not mentioned at all) , it is directly included in the game rules of the so-called "expanding the second phase of human clinical trials". With the maximum subsidy of 500 million yuan as an incentive, the number of subjects in the second phase of the Taiwan-made vaccines must reach at least 3,000. never mentioned doing phase 3 experiments.
A professor at the Medical School who assisted the CDC in formulating a subsidy for self-produced vaccines admitted that at that time, the three high-end, Lianya and Guoguang vaccine operators, first heard that the second phase of human clinical trials would have to be more than 3,000, and they all rushed to the sky, because under normal circumstances, even the second phase of human clinical trials of multinational manufacturers would only be hundreds of people. Later, he told the industry that it was very righteous: "Think about it, if the second phase does not do more than 3,000 people, you must do the third phase. But the scale of the third phase human clinical trial not only requires tens of thousands of people, but also needs to go to the epidemic area for cross-border trials." Only then did the industrialists on the island accept it silently. In order to convince Taiwanese vaccine operators to achieve more than 3,000 phase 2 trials, they can be exempted from the third phase, the CDC also issued a reason for each operator to receive a maximum subsidy of 500 million yuan.
The author believes that the homemade vaccine on island must be used urgently in July. It is best if the vaccine is safe and effective, but even if it is safe but ineffective, it will be even worse. Because that is self-deception, ineffective vaccines cannot create an immune barrier, and instead delays the injection of effective vaccines. The consequence is the same as "blocking".
