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Written by: Zheng Cuibi
2021-01-28 16:21
Last update date: 2021-01-28 16:26
The mainland Kexing vaccine purchased by the Hong Kong government has yet to submit a complete report of the third phase of the test.
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The chief executive has sought assistance from the central government. It is rumored that the central government will distribute vaccines from the mainland to Hong Kong. However, Sinopharm has also not released the third phase of the complete report.
Leung Zhuowei, a member of the Vaccine Advisory Expert Committee and Dean of the Faculty of Medicine of the University of Hong Kong, said today (28th) that all vaccines require solid scientific data and foundation before the approval process can be carried out. The approval process is the same regardless of which vaccine is used.
He also said that recently, both Kexing and Sinopharm have submitted data to the WHO, and he believes that they will be fully announced in the next few weeks. He hopes that Hong Kong can obtain the data as soon as possible.
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When asked whether it is agreed that vaccines in the Mainland can be used in Hong Kong without the report of the third phase clinical study, Leung Zhuowei said that all vaccines "the most important thing is to see whether they have a solid scientific basis, whether they are recognized by the world, including the WHO." If there is data support, we will definitely do the approval work.” He pointed out that when the government pre-orders vaccines, all clinical data is not required, but when it is officially purchased and distributed, the processing is different. Solid data is required and verified And approve "use whatever you get."
Liang Zhuowei said that all vaccines require solid scientific data and foundations before they can be approved. The procedure is the same regardless of which vaccine is used.
(Photo by Lu Yiming)
Liang also said that the approval procedures for all vaccines are the same, requiring Phase I, Phase II, and Phase III test data. "Any vaccine, whether for emergency use or permanent approval, requires solid scientific data."
Regardless of whether it is the vaccines of Kexing and AstraZeneca, the "procedures are the same." The committee has already approved the BioNTech vaccine earlier. The vaccine has not only published data in international journals, but also submitted more than 1,000 pages of information to the committee. Lots of different data.
He added that in recent days, both Kexing and Sinopharm have submitted data to the WHO. I believe they will be fully announced in the next few weeks. I hope Hong Kong will obtain the data as soon as possible.
He also said that Kexing published the first and second data in international journals earlier, and did not think that Kexing would not publish the third data, and that this practice was an international practice.
Executive Council member Tang Jiahua asked experts yesterday to explain the reasons why Sinopharm vaccines cannot be used in Hong Kong. Some members insisted that the bottom line is that pharmaceutical companies must submit a complete Phase III clinical research report.
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