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Author: Zhu Haiqi
2021-01-31 18:27
Last update date: 2021-01-31 18:29
The establishment believes that Hong Kong can introduce mainland Chinese medicine vaccines that do not have Phase III clinical data, while experts insist that a Phase III report is required.
In fact, vaccine development is generally divided into three phases of clinical trials, which can only be released after passing, so the third phase data is regarded as the "final chapter."
Some doctors and pharmacists have pointed out that the number of people involved in the third phase of the vaccine must be over 10,000, and high-risk individuals are involved. They can provide detailed and careful data analysis. "The first and second phases are only preliminary clinical studies. Exploring, the third phase first came to a conclusion on the safety and effectiveness of the vaccine."
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The third phase of data adds high-risk individuals
The dispute over the necessity of the third report remains deadlocked. Cui Junming, president of the Hong Kong Society of Hospital Pharmacists, pointed out that the third period data has two importance.
He pointed out that the clinical trial of the vaccine is divided into three phases. The first phase will recruit more than 10 people, the second phase will recruit about 100 to 200 people, and the third phase will have at least 30,000 to 40,000 people. "Statistically, the chances are easy to establish. "It is representative, established on the data, and highly reliable." It is also easier to find side effects and rare adverse reactions of the vaccine.
Extended reading: Kexing Vaccine│Lu Chongmao: The third phase of the data is not necessary to call on the Hong Kong government to actively obtain from the pharmaceutical factory
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The second is the research object. Cui Junming said that the participants in the first and second phases are healthy people, but high-risk people will be added in the third phase. "(The third phase) is well divided, and patients with chronic diseases are involved. High-risk groups such as human diabetes, obesity, and elderly age will be seen." It can provide detailed data for the government and experts to consider the effectiveness and safety of vaccines.
Liang Zichao pointed out that only the third phase of the data has a conclusion on the effectiveness and safety of the vaccine.
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Liang Zichao: Only the third phase has a valid conclusion
Respiratory specialist Liang Zichao added, "The first and second phases are only for preliminary clinical research and exploration, and the third phase is to have a conclusion on the safety and effectiveness of the vaccine", because the vaccine involves large-scale population vaccination, which is life and health. The more detailed data can help the authorities assess the benefits and risks of this vaccine.
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