The Food and Drug Administration of Taiwan’s Ministry of Health and Welfare announced that an expert review meeting has been completed this week (July 17) and an application for the “Emergency Right to Use” (EUA) of high-end new coronary pneumonia vaccines has been approved, allowing project manufacturing. It is expected to be available in August this year at the earliest. Provided for Taiwanese people over the age of 20 to fight.
According to the information published by the Director of Taiwan Food and Drug Administration, Wu Xiumei, 21 experts attended the review meeting. Among them, the chairman did not participate in the voting, 18 agreed, 1 supplemented the reconsideration, and 1 disagreed. Taiwan’s Minister of Health and Welfare Chen Shizhong said that these are all scientific review results and will be sent to the vaccine team for discussion as soon as possible.
The high-end is Taiwan’s first domestically-made new crown vaccine approved and approved, and the second self-made vaccine “Lianya” is also accelerating research and development. However, because high-end vaccines were first introduced in the third phase of trials with “immune bridging”, which is different from most international mainstream vaccines, it has aroused fierce public opinion in Taiwan.
Kuomintang Chairman Jiang Qichen went to the Taipei Prefectural Prosecutor’s Office today to ring the bell to accuse Chen Shizhong and the Ministry of Health and Welfare of “crimes for profit”, saying that the purchase of high-end vaccines of up to NT$4 billion did not meet international standards. He hopes judicial investigations.
Taiwan think tank “National Defense Security Research Institute” Dr. Su Ziyun analyzed to the BBC Chinese that the emergency authorization of Taiwan’s homemade vaccine can meet the goal of “emergency rescue” and return to the international community and humanitarian assistance. He estimated that by the end of 2021, Taiwan will be self-sufficient, while at the same time assisting Taiwan’s diplomatic countries and developing countries to alleviate the global shortage of vaccines.
No Phase III trial
The high-end vaccine has passed the review and is the world‘s first new coronary pneumonia vaccine that has not yet undergone the third phase of clinical trials and passed the EUA through immuno-bridging. This is also the most discussed point from all walks of life. Before the outbreak of the new crown, many other vaccines around the world also used immune bridging.
The so-called “immune bridging” refers to the comparison of the “neutralizing antibody amount” in the laboratory after the vaccine is administered. In the US FDA, it has not been accepted for emergency use authorization.
Therefore, many critics believe that it is not rigorous to replace the third phase of the experiment with immune bridging. This topic once became one of the most concerned topics in the Taiwan epidemic.
Kuomintang Chairman Jiang Qichen repeatedly criticized when he sued the Ministry of Health and Welfare. Without phase III clinical trial data, “it is impossible to know whether high-end vaccines can clinically reduce infections and reduce the proportion of severe illnesses, and whether they are comparable to other mainstream vaccines… It will be verified in the future whether the high-end can effectively fight against the new variant virus that is now ravaging the world?”
Huang Limin, the director of the Children’s Hospital of National Taiwan University Hospital, also told the Taiwan Media Health Journal that “the human test is currently only carried out to the second phase, which can only prove that the safety is no problem, but the third phase of the human test has not been carried out. The protective effect is unknown. The effectiveness of protection can only be estimated from the titers of neutralizing antibodies.”
Liu Shiren, a researcher at the Institute of Infectious Diseases and Vaccines of the National Institutes of Health in Taiwan, also stated in the Health Journal that in the absence of Phase III clinical data, “From the titers of neutralizing antibodies, it seems that the effectiveness of domestic vaccines is more worrying.”
However, Taiwanese biomedical experts and Professor He Meixiang from the Institute of Biomedicine of the Academia Sinica stated that the use of neutralizing antibodies as a protective alternative indicator has a regulatory and scientific background.
He Meixiang posted a post on his personal Facebook, for example, the annual inspection of Taiwanese influenza vaccine regulations when replacing antigens, all cited this method: “The prerequisite behind this is that the experimental methods for quantifying antibodies have been standardized and all use internationally unified methods. Standard reagents. Therefore, the antibody level of each vaccine can be compared with each other.”
He Meixiang also emphasized that “EUA verification is based on the actual situation of each country. If foreign vaccines are delayed, the domestic epidemic situation is high, and after the domestic vaccine is reviewed, it seems that the school price of neutralizing antibodies is not inferior to AZ (now He is the only one who fights in the country), so why not use it?”
Politicized vaccine options
The issue of Taiwan’s own production of vaccines did not receive much attention before the outbreak of the local epidemic in May. The people of Taiwan had very low interest in administering vaccines, and the barriers to entry into in-depth medical science discussions were high.
However, since the outbreak of the local epidemic, what kind of vaccine should be vaccinated has once again followed Taiwan’s different political stances, arousing intense debates and differences of opinion.
At the beginning of June this year, during the peak of the diagnosis of the local epidemic in Taiwan, the results of an online poll by the Chengchi University Election Research Center showed that 84% of the people preferred to choose BioNTech and 86.2% to choose Modena when they had the opportunity to administer the vaccine. 62% of those who choose Jiaosheng and 52% of AZ vaccines; 28.1% for high-end and 25.6% for Lianya. In addition, 17.3% of the people will choose China-made vaccines, and 56% will choose Chinese agents instead of Chinese-made vaccines.
Taiwan’s public opinion is also concerned about whether Taiwan’s President Tsai Ing-wen and Vice President Lai Qingde will receive high-end or Lianya vaccines as expected. The President’s Office of Taiwan said on Monday that “will follow the command center’s plan for opening up and implement appropriate follow-up plans on this issue. , If there is a final decision, it will be explained to the public in due course.”
Why does Taiwan urgently need local vaccines?
When the world is in the crisis of the new crown variant vaccine, “vaccine protectionism” has been plagued by global epidemic prevention.
In April this year, India was caught in an epidemic crisis. The major Indian vaccine manufacturer, which was contracted by AstraZeneca, announced a temporary ban on the export of AstraZeneca vaccines, resulting in global contracted buyers including Taiwan not being able to get the vaccine. In June of this year, the European Union (EU) sued AstraZeneca for delayed delivery to the International Court of Justice, and the court ruled in June that the plant could only be delivered on schedule in September.
Analysis believes that Taiwan needs to produce its own vaccines because “prevention is like fighting.” Vaccination is not only regarded as the key to fighting the new coronavirus, but also a strategic weapon. In particular, Taiwan has always been on the fringe of the International Health Organization and has to “rely on its own.”
Based on this, Su Ziyun analyzed to the BBC that the Taiwanese government’s granting of the EUA to the self-produced vaccine is also in line with this year’s G7 summit’s “Hundred Day Mission” joint declaration. The declaration pointed out that in the face of non-traditional threats, under the premise of ensuring safety and effectiveness, the vaccine development and testing procedures can be shortened to 100 days to respond to new biochemical threats.
In his 30s this year, Mr. Ling, a Taipei citizen with a doctor background (required a pseudonym), explained to the BBC in Chinese that the greater the coverage of vaccines, the better, but he believes that Taiwan needs its own vaccines to face the international shortage of vaccines and future variants of the virus. “I am very confident in domestic vaccines, and Taiwan really needs to have its own vaccines to protect itself.”
However, Taiwan’s internal worries about domestic vaccines have not ceased.
For example, will vaccination of self-produced vaccines affect future international tourism? Do other countries accept it? Huang Limin of National Taiwan University Hospital said: “Domestic vaccines can still produce antibodies, and they will always have a certain degree of protection. There is no need to worry about safety. It may be possible to deal with the domestic epidemic… The question is whether people who have received domestic vaccines should continue. What should we do if we use other brands of vaccines? And what should we do if domestic vaccines go abroad without international certification? These are all complicated issues.”
However, some people also say that the high-end vaccine is to sign an authorization and technology transfer contract with the National Institutes of Health (NIH) to obtain a new coronary pneumonia candidate vaccine and related biological materials, and conduct research and development and production in Taiwan. Therefore, at least the certification problem in the United States will not be too big in the future.
The high-end company issued a statement stating that it will implement relevant safety monitoring in accordance with regulations, and conduct the third phase of clinical trials and other confirmatory trials “with the goal of obtaining conventional drug certificates and international certification.”