Political Influence Clears Half-Tested Taiwan Vaccine for July Inoculation
The first domestically produced vaccine in Taiwan successfully unblinded. Yet Chen Pei-jer, who recently resigned from the vaccine review committee of the Food and Drug Administration, Ministry of Health and Welfare, due to his dissatisfaction with the administration of President Tsai Ing-wen for overriding science with politics, indicated that this is merely a planned script with no surprises.
Taiwan’s Medigen Successfully Unblinds Phase 2 Vaccine Clinical Trials, EUA Review as Early as July
China Times, June 11, 2021
Medigen Vaccine Biologics Corp., a biopharmaceutical company based in Taiwan, unblinded the phase 2 clinical trials of its coronavirus (COVID-19) vaccine. General Manager Charles Chen announced on June 6 that the phase 2 clinical trial was "successful in unblinding" with safety, tolerability, and no adverse reactions, and Medigen would speed up its phase 3 clinical trials. Regarding the vaccine candidate’s demonstration of its efficacy and its international certification, Medigen will hammer them out in a scientific way, and strive to be listed in coming July. Frustrated with President Tsai Ing-wen's "politics before science approach", Academician Chen Pei-jer of Academia Sinica, who resigned from the vaccine review committee of the Food and Drug Administration (FDA), Ministry of Health and Welfare (MOHW), stated that this is a planned script with no surprise.
Medigen Claims Safety, No Adverse Reactions
The phase 2 of the Medigen unblinding was claimed to be a success, when will the inoculation across Taiwan be carried out? Executive Vice President Leo Lee indicated that the data will be submitted to the FDA in the hopes of obtaining the emergency use authorization. If everything goes well, vaccines will be available in July. At the same time, the Medigen will also consult with the European Medicines Agency and others to apply for the Phase 3 clinical trials, with the ultimate goal of obtaining a regular drug certificate for the vaccine and international certification. Deputy Division Chief Wu Ming-mei of the FDA stated that the Medigen will submit the results of the phase 2 clinical trial to the FDA for review. In late June, the said results will be compared with that of AstraZeneca vaccine to measure the efficacy. As early as July, an expert meeting is expected to be held for review. If a green light is given then, the FDA would speed up its administrative tasks, It would take three to five days to sort out.
According to media commentary, President Tsai announced that the domestic vaccine will be administered to the public in July before the vaccine completed unblinding of second-phase clinical trials and obtained emergency use authorization (EUA). This obvious political intervention has undermined impartiality in the scientific profession.
With President’s Interference, How Can Scientists Review Vaccines Impartially?
United Daily News Editorial, June 9, 2021
With Taiwan mired in a serious shortage of coronavirus (COVID-19) vaccines, the administration of President Tsai Ing-wen is forcefully promoting domestically developed vaccines and even purposely halting the import of foreign vaccines. It came as a shock that Academician Chen Pei-jer, of Academia Sinica and a member of the vaccine review committee in the Food and Drug Administration (FDA), Ministry of Health and Welfare (MOHW), decided to resign from the committee late May due to external political interference. He claims that the domestic vaccines are unable to receive Emergency Use Authorization (EUA) before July and stated that the biggest obstacle for vaccine review is President Tsai. It is startling that the vaccine chaos in Taiwan involves a tussle between the president and a scientist.
The reason behind Dr. Chen’s resignation is straightforward because President Tsai has publicly announced that domestic vaccines will be available in July so there is no way for the FDA to resist this pressure but to approve the vaccines. Being a scientist and unable to examine the vaccine impartially, Chen chose to resign. We have respect for Dr. Chen’s demonstrated professionalism. But if his concern is correct, then the FDA could hastily approve the domestic vaccines under the President’s pressure. If the domestic vaccines are provided to the public without going through honest and proper review procedure, then is it possible that the general population will become guinea pigs for the domestic vaccines?
Although Taiwan's domestically-produced vaccine successfully unblinded second-phase clinical trials, there remain many issues, including efficacy, immuno-bridging standards inconsistent with international practices, and social inequality that has worsened during the pandemic.
(Photo from: The Storm Media)
Besides Vaccine Shortage, Taiwan Faces More Dangerous Pandemic Complications
By Kuo Hung-chi
The Storm Media, June 12, 2021
The highly anticipated unblinding of the Phase II clinical trial of the coronavirus (COVID-19) vaccine produced by Medigen Vaccine Biologics Corporation (MV) was successful on June 10.This result is in line with expectations, but it only proves that the safety of the vaccine and the antibody concentration meet the standards.The Medigen vaccine passed the second phase of clinical trials, but it did not answer the most important question: how protective is the domestic Medigen vaccine? Article 48, Section 2 of the Pharmaceutical Affairs Act stipulates that in response to urgent public health needs, the central health authority may approve the manufacture of specific drugs on a special basis.The Food and Drug Administration, Ministry of Health and Welfare, also announced the emergency use authorization (EUA) conditions for domestic vaccines before the unblinding of Medigen vaccine, mainly in the form of immuno-bridging, using neutralized antibodies as the efficacy indicators.
Taiwan’s Inconsistent Immune Bridging Standard
In order to cope with the successive unblinding of two domestic vaccines, and to realize President Tsai Ing-wen’s announcement of “launching smoothly the vaccine shots from July”, the Ministry of Health and Welfare (MOHW) has prepared the Immunization Bridging scheme. This immune bridging is that, to make an official announcement setting up an antibody standard, and vaccines that meet this standard may waive the third phase of clinical trials. The Food and Drug Administration commissioned the MOHW hospitals to collect neutralized antibodies from 200 people who have received the AstraZeneca vaccine, from MOHW-associated hospitals as a control group. The neutralized antibody titer of the domestic vaccine should not be inferior to that of the AstraZeneca vaccine. If the neutralized antibody of AZ is 100, the neutralized antibody of the domestic vaccine cannot be lower than 67.
According to Su Chi, former secretary-general of the National Security Council, President Tsai is akin to a "quasi-emperor." Not only do constitutional institutions fail to effectively check and balance her power, but like the manner described in the book
How Democracies Die, President Tsai is also eroding Taiwan's long-standing democracy.
Is Taiwan's Democracy Also Critically Ill?
By Su Chi
United Daily News, June 13, 2021
The coronavirus (COVID-19) pandemic has worsened; public grievances are boiling over; and President Tsai Ing-wen's approval ratings continue to falter. There are now two types of criticisms against President Tsai: First, why has she failed her baseline responsibility of protecting public health? Second, why has she not responded directly and thoroughly to public concerns? The complaints of “irresponsibility” and irresponsiveness” point to a deeper question: Is Taiwan's democracy also seriously ill?
When I served in the government those early years, I whole-heartedly supported Taiwan’s democratization and cross-Strait reconciliation. Witnessing the ongoing, slow but sure wreckage of these two major historical achievements from within Taiwan itself saddens me to no end.
The coronavirus (COVID-19) epidemic alert in Taiwan has been raised to level 3 for a full month, and the mortality rate from infection reached 3.2 percent, higher than the global rate. According to an expert, the advanced age of patients as well as inadequate notification and medical system explain why patients fail to receive appropriate medical care in time and are main reasons behind Taiwan's high mortality rate.
(Photo from: The Storm Media)
June 6: The rainy season and typhoon Caiyun brought abundant rainfall to Taiwan. Minister of Economic Affairs Wang Mei-hua, who heads the Central Drought Disaster Response Center, announced that the mechanism in Miaoli, Taichung, and northern Changhua where water would be supplied for five days but suspended for two days per week would be lifted immediately. The red-light water-use restriction this time lasted some 61 days, breaking the previous historical record of 54 days in Taipei in 2002. It is expected that current water conditions will be stable until the end of July.
June 10: The Good Liver Clinic in Taipei was exposed to have claimed 115 bottles of AstraZeneca vaccines on June 7 and June 8 and vaccinate more than a thousand volunteers. The Taipei City Government determined that the volunteers did not qualify for the first to third priority categories for inoculation, imposed a fine of NT$2 million (about US$72,318), and canceled the clinic's qualifications as a vaccination contract hospital. Professor Hsu Chin-tsuan, who is chairman of the Good Liver Foundation, recorded a video on June 10, apologizing for the inconvenience caused.
The list of vaccinated individuals was revealed to include various media celebrities, as well as volunteers, cleaners, and janitors totaling 1,285 people.
The matter has aroused widespread controversy. Ironically, the clinic which administered vaccines was fined, and those vaccinated had to apologize publicly, even though the real underlying reason is a shortage of vaccines.
June 10: The second phase trials of domestically produced Medigen Vaccine Biologics (MVC) vaccines was successfully unblinded. Responding to interpellation at the Legislative Yuan about the price of domestic vaccines, Minister of Health and Welfare Chen Shih-chung revealed that the price would be "a bit higher" than the originally budgeted unit price of NT$750 (about US$27). It is rumored that the Medigen price per dose is as high as NT$881 (about $31.8), eight time higher than that for the AstraZeneca vaccine, inviting widespread criticism. Taipei Mayor Ko Wen-je stated that AstraZeneca costs NT$111 (about US$4) per dose, Moderna NT$416 (about US$15), Pfizer NT$540 (about US$19.5), but Medigen vaccines cost NT$881 dose. Medigen is more expensive than all the others, but its effectiveness remains to be known.
June 10: United States Trade Representative Katherine Tai and Minister without Portfolio John Deng, who is also chief negotiator of the Executive Yuan's Office of Trade Negotiations, held a video conference. This is the first dialogue between the trade representatives of the two countries since the administration of President Joe Biden took office. Tai stressed the importance of U.S.-Taiwan trade and investment, and talks on the U.S.-Taiwan Trade and Investment Framework Agreement (TIFA), which have been dormant for four years, will resume in a few weeks jointly presided by the American Institute in Taiwan (AIT) and the Taipei Economic and Cultural Representative Office (TECRO) in the United States.
June 11: Dissatisfied with the government's sluggish procurement of internationally certified vaccines, former Director-General Chung Chin of the Government Information Bureau, Executive Yuan, went to the Taipei District Prosecutor's Office to file a complaint against President Tsai Ing-wen, Premier Su Tseng-chang, Minister of Health and Welfare Chen Shih-chung for suspected malfeasance, profiteering, and document forgery. In their complaint, Chung and co-plaintiffs criticized the three for making things difficult and obstructing individuals and private groups like Foxconn founder Terry Gou, the Buddha's Light International Association, Principal Chang Ya-chung of the Sun Yat-sen School, and New Party to act as intermediaries and facilitate large numbers of internationally certified vaccines, only to favor domestically produced Medigen vaccines.
June 11: After the Medigen vaccines successfully unblinded, the stock price surged to the upper limit. In a radio interview at noon, President Tsai stated that vaccines are expected to be available to the general public in July and emphasized that she and her family did not buy stocks, so allegations of speculation is really slander. This is the third time in 12 days that President Tsai personally responded to rumors of manipulating stock prices. She also apologized for the 385 cumulative number of deaths due to the pandemic.
President Tsai stated that over the past month, the government has made adjustments and changes to respond to the pandemic. Screening stations have been opened in higher-risk areas, and companies have also invested in rapid screening, hoping to minimize short-term infection risks.
June 11: In July 2019, national security personnel used President Tsai Ing-wen's foreign visit to smuggle 9,793 cartons of illicit cigarettes. The Taipei District Court convicted 14 individuals, including nine national security personnel, four China Airlines staff members, and one friend of Secret Service personnel, of which two former National Security Bureau majors were sentenced to more than 10 years. Observers criticized the judgment for identifying an errand boy as the mastermind.
June 12: The raising of the coronavirus (COVID-19) epidemic alert has been nearly a full month. As of June 12, the total number of confirmed cases reached 12,746, with 411 deaths. The death rate due to transmission is 3.2 percent, higher than that of Singapore, Japan, and the United States. Twenty-six (26) additional deaths were reported on June 12, of which six died in less than five days since they tested positive and seven were confirmed positive after they were found dead. According to experts, the senior age of patients as well as inadequate notification and medical system are main reasons for the high mortality rate and why patients are not able to receive appropriate medical care in time.