Hong Kong‘s expert panel advising the government on the approval of a new crown vaccine said they unanimously agreed to recommend that the local government introduce the CoronaVac vaccine developed by China’s Kexing Biologicals. It was noted that the vaccine’s phase III test data was not published in international medical journals and did not meet the standards set by the Hong Kong government earlier, but was still recommended by the expert committee, raising questions.
The expert committee convener Liu Zexing and member Xu Shucheng pointed out on Tuesday (February 16) that the field test showed that the efficacy of the vaccine (efficacy) in groups over 18 years of age ranged from about 50% to 91%, and that the benefits outweighed the risks, so it recommended approval for use.
After the committee will write a detailed report to the Hong Kong government for review, the government will then formally decide whether to grant emergency use permits for Kexing’s vaccine.
Liu Zexing also said that the information obtained by the expert committee when examining the vaccine was more detailed than the data generally submitted to scientific journals, stressing that the committee’s work was not subject to “any pressure” from the government.
But Hong Kong Chief Executive Carrie Lam said earlier that the local government has three criteria for the emergency approval of the new crown pneumonia vaccine, including the requirement for the pharmaceutical company to provide clinical test data, the approval of the vaccine by overseas regulatory bodies, and the relevant test data have not been published in medical journals. She also pointed out that the relevant legislation allows for exemptions from any of these requirements.
The process of seeking an emergency use permit for the new Crown vaccine manufactured by Kexing in Hong Kong has not always been smooth. The Hong Kong government first signed an order with the company in December last year, but by the end of January it still had not received complete clinical data, and only in the first week of February did it receive information from the company to the World health Organization and other local regulatory agencies.
The Hong Kong government panel held a press conference on Feb. 10, saying that Kexing needed to provide further information before deciding whether to recommend its use. The Hong Kong authorities received the relevant information within days afterwards, and the expert group met again afterwards, finally deciding on Tuesday to recommend the use.
In addition to Kexing, Hong Kong has earlier ordered vaccines from Fosun Pharmaceuticals/German pharmaceutical company BioNTech and AstraZeneca/Oxford, and the authorities have earlier approved Fosun Pharmaceuticals/BioNTech’s vaccines for emergency use, while AstraZeneca/Oxford has not yet applied to the Hong Kong government for emergency use.
Controversy over the exemption requirement
The public is concerned that Kexing did not publish the test data in medical journals, but still got the recommendation for use. In response, Hui Shu-cheong pointed out that some members of the committee are medical journal reviewers, and believed that the test data from the third phase of Techsun would be published by some journals.
However, the president of the Association of Public Medical Doctors (APMPD), Ma Chung Yee, believes that there is still a gap between this and the approval of medical journals to publish the test data. In an interview with the Hong Kong media, she pointed out that international medical journals will have researchers of different nationalities asking questions that drug companies will need to answer before they can be approved. She described that it depends on how the public sees the issue of trust between pharmaceutical companies and experts.
Liu Zexing was interviewed by the Hong Kong media and revealed that they had asked several questions to each other when approving Kexing’s vaccine and received responses before finally deciding to recommend its use. He also said that WHO will discuss in March whether to recommend the emergency use of the vaccine, if the vaccine is found to be problematic, the expert committee can always re-examine the decision to recommend.
Chairman of the Hong Kong Medical Association Advisory Committee on Infectious Diseases Leung Tze Chiu pointed out that the WHO review of the relevant vaccine process and supply has lagged behind, many countries because of the seriousness of the Epidemic, did not wait for the WHO to allow the emergency use of vaccines according to the results of their own approval.
He was interviewed by the Hong Kong media and said he believed that the expert committee was examining the vaccine according to WHO standards. Despite this, he said that if the government fully disclosed the clinical trial data of the vaccine, it could increase public confidence in the vaccine.
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