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.
At the end of May, the World Health Organization (WHO) meeting discussed the issue of immunization bridging but did not reach a conclusion. That is to say, the WHO has not yet announced a comparison standard for immunization bridging of the coronavirus vaccine. However, Taiwan intents to set up its own standard for domestic vaccines.
The reason why the WHO meeting did not make a conclusion on the immunization bridge of the coronavirus vaccine is because there are many controversies to be resolved. In an interview by the Journalist, Academician Chen Pei-zhe of Academia Sinica stated that the immune bridging pair is feasible only to those which have accumulated with many cases, and used many years as a mature vaccine or medicine.
In addition, Director Chen Chien-wei of the Clinical Trial Center of National Taiwan University Hospital also pointed out in an interview with United Daily News that the immune bridging test should be in the same test, but the Medigen vaccine is a different test from its AstraZeneca vaccine control group. Therefore, it does not conform to the principles of clinical trials.
On the bright side, at a time when vaccines are urgently needed worldwide, the Taiwanese government has spared no effort to set up fast lanes so that domestic vaccines can be marketed as soon as possible, so that Taiwan may have more "strategic materials" and can be more at ease. However, even if the Medigen vaccine has passed the second phase of clinical unblinding, and even if it has obtained the EUA from Taiwan’s MOHW, it still lacks international certification. There are still many uncertainties about its protective power, and whether it is effective against variant virus strains is still unknown.
With so many uncertainties, it is still doubtful whether the Medigen vaccine and another domestic vaccine from UBI Pharma, which is undergoing second-phase unblinding, can be trusted by the Taiwanese people, and whether the domestic vaccines can ultimately protect the Taiwanese people remains untested.
Although the vaccine is the final solution, even if all kinds of vaccines are launched in the middle of June, there is still a long way to go to achieve herd immunity. Europe, the United States, Japan, and South Korea have experienced three or four waves of pandemic ups and downs for more than a year. Even at the beginning of the vaccine campaign, the pandemic situation is still on the rise, and it is still uncertain whether Taiwan can survive the epidemic ordeal in a relatively stable way. Taiwan needs vaccines, but what is more urgent now is screening, hospital beds, and medicines. Taiwan has shortage in these areas. When the level 3 alert was extended again and again, the death toll continued to rise, economic activities stagnated, and Taiwan still sees no light in the long night of the pandemic.
Social Inequality Worsening Amid Pandemic
The torment of the pandemic is to face the shadow of death. Facing death also reveals the dark side of human nature. Including the Good Liver Clinic incident, various privileged people rushed to get the vaccine, but many epidemic prevention personnel who were actually on the front line were unable to get the vaccine. At the time of life and death, this unfairness will ignite huge anger among the people.
Social inequality has also worsened during the pandemic. When schools are closed, "no classes but no suspension of learning" is just a distant slogan for many students from disadvantaged families. Parents of well-off children have arranged various online and offline learning activities for them. Parents of disadvantaged families still have to go out to earn a living during the pandemic, and they have no time to take care of children who have suspended classes. Summer vacation is approaching. How long can young people who are growing and energetic stay in their room? These will bring new social problems and epidemic prevention problems.
It has only been less than a month since the pandemic intensified in the middle of May. The various economic and social side effects of the epidemic have not yet emerged, and many ordeals are just about to begin. In face of the pandemic, there is no reason to be optimistic.
The author is editor-in-chief of the Journalist.