Home World New Taiwan-made COVID-19 vaccine launched Tsai Ing-wen has been vaccinated with the world’s first emergency use of “immune bridge” to skip the third phase of testing | Position report

New Taiwan-made COVID-19 vaccine launched Tsai Ing-wen has been vaccinated with the world’s first emergency use of “immune bridge” to skip the third phase of testing | Position report

by news dir

The Taiwan-made “high-end” COVID-19 vaccine began to be used in Taiwan today. President Tsai Ing-wen went to the National Taiwan University School of Medicine Gymnasium to take the lead this morning (23/8). This vaccine is the world’s first COVID-19 vaccine that has undergone the “immunobridging” test process, skipping the third phase of clinical testing and used emergency COVID-19 vaccine.

Tsai Ing-wen broadcasted the injection process on Facebook this morning. After the injection, she said, “This injection is quite easy and feels nothing.”

This Taiwan-made vaccine is produced by Taiwan High-end Vaccine Biologics Corp. (MVC, Medigen Vaccine Biologics Corp). It is called “High-end Vaccine” in Taiwan. The technology is authorized by the National Institutes of Health (NIH) and the University of Texas at Austin. , Jointly develop S-2P spike protein original biological materials, verification antibodies, and technology platform, and use genetic recombination technology to produce S-2P spike protein on the surface of the virus to stimulate the immune system of the vaccinators, thereby producing protection against COVID-19 The vaccine adjuvant is provided by Dynavax, USA.

Among the most questioned is the “immune bridging” test standard, which allows the vaccine to skip the third phase of clinical testing. The so-called “immune bridging” is a testing process that compares the “neutralizing antibody levels” of existing vaccines and new vaccines under development in the laboratory, replacing the results of the third phase of clinical testing; similar practices are also used in Taiwan’s past influenza vaccines Useful.

The BBC Chinese quoted Professor Zhang Wenwei from Sun Yat-sen University of Medicine in Taiwan as explaining that “Immune Bridging” uses immunological correlate of protection (ICP) indicators to serve as the basis for new vaccine approval and marketing review without final clinical effectiveness data. The immune analysis of antibodies or immune cell T cells can be used as an assessment of ICP.

However, Chen Xiuxi, a professor at the Institute of Epidemiology and Preventive Medicine at National Taiwan University, criticized: “One is to get a degree after formal graduation, and the other is an equivalent degree. The second period and the third period are to replace the formal degree with the equivalent degree.”

Adrian Esterman, a professor of epidemiology at the University of South Australia in Australia, told the BBC Chinese that immune bypass refers to the inference of vaccine efficacy based on the vaccine’s ability to generate an immune response, rather than the results of the third phase of clinical testing. In the past, under normal circumstances, immune bridging tests were performed when the vaccine manufacturer had already carried out the third phase of clinical testing to develop vaccines, but wanted to modify the existing vaccines against new variant virus strains or a new batch of populations such as children. Use this way. He believes that the current practice is quite controversial. When other countries consider vaccine passports, Taiwan-made “high-end vaccines” may have major problems.

The high-end COVID-19 vaccine uses the neutralizing antibody of the Oxford-AstraZeneca COVID-19 vaccine as an alternative efficacy indicator in the “immune bridge”.

When the Food and Drug Administration of Taiwan’s Ministry of Health and Welfare announced the safety data of high-end vaccines last month, the seroconversion rate of testers who received high-end vaccines was 95.5%, and the geometric mean titer ratio (GMTR) of neutralizing antibodies was Oxford. -3.4 times that of the AstraZeneca vaccine group. Both indexes are much higher than the standard, so they passed the review of the expert committee. However, the high-end still has to provide monthly data on the protection benefits of domestic and foreign vaccines within one year of the vaccine’s approved use, and continue to conduct the third phase of clinical testing simultaneously. In addition, with the approval of the Paraguayan government, the third phase of clinical testing of the high-end vaccine was launched locally at the end of July.

According to the results of the second phase of clinical testing, people receiving high-end vaccines may have local symptoms such as needle pain, erythema, and swelling. Systemic side effects include muscle soreness and fatigue, but no serious side effects have been recorded as of June this year. Record.

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