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Written by: Zheng Cuibi
2021-05-10 12:35
Last update date: 2021-05-10 12:35
The World Health Organization announced on Friday (7th) that it has approved the emergency use authorization of the "Sinopharm Vaccine" developed by China. However, for another "Kexing Vaccine" developed in the Mainland and used in Hong Kong, the drug manufacturer still has to wait. Provide more information and expect to make a decision this week.
"Hong Kong 01" asked Kexing what information the WHO required its company to submit, but Kexing replied that the WHO did not require the submission of new data, and the approval work is still in progress.
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According to the "Reuters" report, WHO experts said that they are requesting more information from pharmaceutical companies, hoping to receive the information as soon as possible to make a decision. It is expected that an announcement will be made this week.
However, Kexing responded to the "Hong Kong 01" inquiry and stated that the WHO did not require the submission of new data, and the approval work is still ongoing.
Kexing vaccine.
(Photo/Photo by Luo Guohui)
In addition, the WHO Advisory Expert Group on Immunization Strategies (SAGE) once said that some data of Kexing vaccine were "low credibility." Kexing responded that it was assessed as a "low level of confidence" (low level of confidence). Group data. The first is the safety data for serious adverse events in the elderly. The main reason is that in the third phase of the clinical study, the proportion of people over 60 years old is relatively low. "But at the same time, the report of the expert group also included our experience in Brazil. And some data from real-world studies in Chile, as well as the safety data of our vaccine in Chile and another vaccine. Vaccinations in Brazil and Chile are given priority to the elderly, so through actual use, it has actually been verified that the vaccine is effective Safety in the elderly population.”
As for the second set of data for the safety data of serious adverse events in patients with comorbidities (Individuals with comorbidities) and patients with underlying diseases, Kexing bluntly stated that "the study of this group is not easy to do", and other vaccines also have sample sizes. Limited questions, "For example, moderna's vaccine, the data evaluation given by the WHO is also a low level of confidence."
The reporter also inquired with the WHO what information was requested from Kexing, but no reply has been received yet.
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