(Fighting New Coronary Pneumonia) Taiwan-made New Coronary Vaccine "Lianya" has not been authorized for emergency use
China News Agency, Taipei, August 16th. Taiwan’s “Food and Drug Administration” announced on the 16th that the UB-612 new crown pneumonia vaccine (referred to as “Lianya Vaccine”) developed by local manufacturer Lianya Biotechnology Co., Ltd. was due to neutralizing antibody data and Compared with the AstraZeneca vaccine (AZ vaccine), which does not meet the set evaluation criteria, it will not be authorized for emergency use.
According to reports from the Central News Agency, China Times News, and United News, at the end of June this year, United Biotech announced the interim report of the second phase of the "Lian Ya Vaccine" clinical trial, stating that the results are not only "in line with expectations", but the vaccine immune response can also counteract Delphi. Tower mutant strain.
The company applied for an emergency use authorization to the relevant departments of the Taiwan authorities on June 30, and said it plans to conduct the third phase of clinical trials in India.
However, at an expert meeting held by the “Food and Drug Administration” on the 15th of this month, 17 of the 21 people who participated in the voting did not agree to grant the “Lianya Vaccine” emergency use authorization because the vaccine data did not meet the standard.
On the 16th, the share price of Uniya Biotech's subsidiary Uniya Pharmaceutical continued to rise after the opening, and the highest price once rose to 207 yuan per share (NTD, the same below).
After the announcement that "Lianya Vaccine" had not been authorized for emergency use in the afternoon, the stock plummeted, dropping to as low as 100 yuan per share.
In accordance with the Taiwanese authorities’ vaccine procurement plan, the health unit has signed contracts with two local vaccine manufacturers, high-end vaccines and Lianya Biotech, to purchase 5 million doses of COVID-19 vaccine each.
Currently, Uniasia Biotech has produced 2 million doses of vaccines. Public opinion is concerned about whether this batch of vaccines will be scrapped without emergency use authorization.
In response, the person in charge of the "Pandemic Epidemic Command Center" of the authorities said that follow-up matters will be handled in accordance with the contract.
According to Taiwan media reports, Taiwan’s local new crown vaccine "high-end vaccine", which has been authorized for emergency use, published an interim report on the second phase of clinical trials on June 10. It then applied for emergency use authorization and passed 39 days later, and was included in the sixth round of public vaccination. Types of vaccines.
At present, 611,000 doses of the "high-end vaccine" have arrived and are being tested and sealed.
However, neither the "High-end Vaccine" and "Lianya Vaccine" have completed the third phase of clinical trials.
Regarding the vaccine efficacy evaluation criteria adopted by the authorities, Chen Peizhe, an academician of Taiwan’s "Chinese Academy of Sciences," said that comparing neutralizing antibody data to determine vaccine efficacy as a criterion for emergency use authorization has no scientific basis, because this data does not represent the actual vaccination. The protective power produced afterwards.
To obtain an emergency use authorization for local vaccines in Taiwan, it must be based on universal standards.
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