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Written by: Zhu Haiqi and Chen Shuxia
2021-01-13 19:19
The last update date: 2021-01-13 23:38
The Hong Kong government intends to arrange for citizens to receive the new crown vaccine as soon as after the Chinese New Year. Two of the vaccines have already announced clinical data, but the China Coxing Vaccine has been repeatedly delayed. The latest Brazilian research data ends in the early morning of today (13th) Hong Kong time When released, its overall effective rate was 50.38%, a drop of nearly 30 percentage points from the 78% mentioned earlier.
The Institute of Pharmacists pointed out that the relevant ratio does not include asymptomatic patients, which means that they are only qualified under the requirements of the World Health Organization. The Kexing vaccine is not recommended for the elderly and people with poor immune systems.
A member of the Hong Kong Government’s Vaccine Advisory Committee pointed out that the relevant data did not mention classification, research objects, etc. The figures currently released are not representative. It is estimated that there will be a third clinical report in one to two weeks, and there will be detailed data analysis , It also means that international and local experts will check and only use vaccines that meet the standards.
A person familiar with the matter disclosed that the expert committee will review the German BioNTech/Fosun vaccine next Monday, and it is expected to be approved today.
Brazil's latest research data was released at the end of the morning (Hong Kong time) today (13th), and its overall effective rate was 50.38%.
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The Brazilian Butantan Institute announced earlier that the local "clinical effective rate" of Coxing Vaccine was 78%, but the newly announced overall effective rate was 50.38%.
Reuters quoted researchers as explaining that this time all mild cases include mild patients who do not require clinical treatment.
About 13,000 medical staff participated in this clinical study.
Brazilian authorities will finalize on Sunday (17th) whether to approve the emergency use of Kexing locally.
Indonesia is the first country outside of China to approve emergency use of Koxing vaccine
Kexing Vaccine has been undergoing clinical trials in Indonesia, Brazil, and Turkey. Among them, Turkey, which has purchased Kexing Vaccine, recruited 7,000 people. In December last year, a preliminary test analysis of 1322 participants announced that the effective rate of immunity was 91.25. %, and the data of the Indonesian clinical test involving 1620 people is 65.3%.
The Indonesian authorities have given the green light. It is the first country outside China to approve the emergency use of Koxing vaccine. Indonesian President Joko Widodo is the first local vaccinator.
However, Cui Junming, president of the Hong Kong Society of Hospital Pharmacists, translated the materials from the Brazilian press conference and found that this study did not include asymptomatic patients. The disease prevention rate in the Brazilian study was 50.38%, which is only under the WHO standard of 50%. Qualified, that is, people who are vaccinated may still be infected after the injection, but the symptoms are mild, and the 95% prevention rate ranges from 36 to 92%. The lower the rate is, the elderly and people with poor immune systems are generally the elderly.
If the morbidity prevention rate is only 50%, Cui Junming said that the immune system of the elderly is not strong, and it is less than 50% after vaccination, which is the same as the flu vaccine reaction. It is recommended that Kexing vaccine be vaccinated for young people. The elderly should have a higher morbidity prevention rate. For the German BioNTech/Fosun vaccine, the Hong Kong government can refer to the British practice to disassemble the German Fosun/BioNTech vaccine to facilitate the inoculation of hospitals, request the Oxford/AstraZeneca pharmaceutical factory to speed up to Hong Kong and contact the other two vaccine companies Sinopharm Group and Janssen are striving to negotiate the feasibility of vaccine purchase.
Cui Junming suggested that Kexing vaccine should be vaccinated for young people. He worried that the elderly would have a poor immune system response and the protection rate after vaccination would be less than 50%.
(Data Picture/Photo by Gao Zhongming)
Kong Fanyi, a member of the Government Advisory Committee of Experts and the director of the Department of Infectious Diseases of the Department of Internal Medicine of the University of Hong Kong, said that the relevant figures of Kexing vaccine are provisional data and do not provide details and representativeness. The government will not be recommended to use it before the third clinical report.
Regarding the recommendations of the Institute of Pharmacists, he believes that it is unfair to comment on the unrepresentative numbers, and quoted the German BioNTech/Fosun vaccine data, "(after injection) 75 years old and above (prevention of disease) is 100%, but the birth rate is low. Well, 50% of Yijia means no one knows, 78% is no one knows, and there is a chance that the 75-year-old's rate of disease prevention is 80%. It's uncertain. You have to look at the classification."
He said that after the report integrates data from Brazil, Indonesia, Turkey and Chile, it needs to be published in authoritative medical journals and reviewed by 4 or 5 experts. The procedures are very rigorous and will review the vaccine's incidence of disease prevention, side effects, and neutralizing antibodies. Level, age group, nationality and ethnicity data, etc., "reliable (reliable) after passing the pass".
Kong Fanyi pointed out that the data of Kexing vaccine in Brazil is not representative.
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Due to the severe epidemic in European and American countries, nearly 10 million people have been vaccinated. Kong Fanyi said that the epidemic in Asia is not out of control. He will wait for the third phase of the clinical report before deciding whether to approve or not. "There is no Commitment, Coxing or Oxford/Ah. There is no way for Salicom to reach the standard. If the expert reviews Okay, it will use it. Any vaccine that does not meet the standard will be used according to the established requirements. It must meet the standard and meet the WHO (WHO) 50% disease prevention requirements. Safety."
▼Protection rate side effects of Kexing, BioNTECH Fosun, AstraZeneca ▼
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Another committee member, Professor Xu Shuchang of the Department of Respiratory System at Chinese University, said that it is difficult to respond to informal data.
He also mentioned that currently only BioNTech has submitted a complete report to the Department of Health.
I was asked if Kexing delayed submitting data, would it affect the committee's approval?
Xu Shuchang said that it is not within their control.
Respiratory specialist Liang Zichao was also not aware of the details of Kexing’s data in Brazil, but said that if 50.38% of the figure includes asymptomatic patients, it means that the infection prevention rate is up to 50%. The relevant rate is not low, and it is even higher than Oxford/Africa. Silikon's vaccine is high; if it does not include asymptomatic patients, the number is low, and only meets the 50% prevention rate required by the WHO.
Kexing vaccine has been studied in different places, but the data in Brazil is worse than other places. Liang Zichao explained that the research subjects in Brazil are medical staff, and the high amount of virus in the hospital environment will weaken the effect of the vaccine. The injection time was only two weeks apart, and the four weeks apart in the earlier study did not follow.
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Brazil’s data is not comprehensive. Liang Zichao believes that regardless of whether the data represents infection prevention or morbidity prevention, under the global pandemic of the new coronavirus, the most important thing is to strengthen personal protection in the short term to prevent patients with moderate to severe symptoms from appearing, otherwise they will It directly affects the burden of the medical system and the high mortality rate. The protection rate of Kexing in related areas has reached 90% or even 100%, so that at most the patients have only cold-like symptoms. "This problem is not particularly serious, but In terms of preventing community transmission, (this) vaccine may not be good prevention.” Until the vast majority of people are vaccinated, especially high-risk groups are vaccinated, so that the community has herd immunity and the virus is not a threat to others. Prevention and control measures.
A member of the government advisory expert committee who did not want to be named stated that the German BioNTech/Fosun vaccine data is clear and there is no need to request additional data from the pharmaceutical factory. It is expected that the approval will be available on Monday (18th) and the vaccine will be sampled after it arrives in Hong Kong. an examination.
The Food and Health Bureau responded that the mRNA vaccine developed by Fosun Pharma and the German pharmaceutical company BioNTech submitted an approval application earlier this month, which was reviewed by the advisory expert committee and submitted its opinions to the director. The committee held a meeting early next week. It also learned that Kexing Holdings ( Hong Kong) Co., Ltd. has announced the test results of its vaccine CoronaVac clinical test in Brazil. The Department of Health has contacted Kexing and actively followed up to obtain relevant data for evaluation as soon as possible.
▼Kexing vaccine needs seven major steps from the laboratory to the market▼
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