Reporters : Dong Ruifeng and Wang Linlin / Publisher : XinhuaNet via ScienceNet
Ref : http://news.sciencenet.cn/htmlnews/2020/8/444795.shtm
Translation, editing : Gan Yung Chyan, KUCINTA SETIA
News (1)
Concerns on SARS-CoV-2 vaccine
With the continuous progress in the research and development of SARS-CoV-2 (covi, in short) vaccines, in recent times, there have been news that "the vaccine is about to be approved for marketing" and "people have been vaccinated" but there are warnings such as covid "may overlap with flu."
The reporters interviewed authoritative organizations and professionals on the above issues, and asked them to answer questions about the covi vaccine that the public is concerned about.
News (2)
CCP's clinical trials of deactivated vaccine and Adenovirus 5 vector recombinant covi vaccine
The reporter learned from the State Council’s Joint Prevention and Control Mechanism that the People's Republic of China’s four covi vaccines have started international Phase III clinical trials, and some trials will complete the first round of vaccination in early September.
Phase III clinical trials are the key research to determine whether a vaccine can be approved for marketing. It will truly verify the safety and effectiveness of the vaccine, requiring a sample size of tens of thousands to tens of thousands. It is reported that the Phase III clinical trial of a covi vaccine that has been initiated is expected to obtain preliminary data as soon as November.
Yang Xiaoming, Chairman of China National Biotechnology Co., Ltd., introduced that the two inactivated vaccines developed by the company have been approved for Phase III clinical trials in many countries in the Middle East and South America, and the total number of participants in the trials exceeds 30,000.
Yin Weidong, Chairman of Beijing Kexing Zhongwei Biotechnology Co., Ltd., introduced that a covi inactivated vaccine developed by the company is steadily advancing Phase III clinical trials in several countries in South America and Southeast Asia.
In addition, the Adenovirus 5 vector recombinant covi vaccine developed by Chen Wei's team at the Academy of Military Medicine of the Academy of Military Sciences is also in an orderly progress in international Phase III clinical trials.
As the covid epidemic is currently under effective control in PRC, the country does not have the objective conditions for large-scale clinical trials. So the above-mentioned Phase III clinical trials are all conducted overseas.
News (3)
Detailed characteristics of CCP's inactivated vaccine and Adenovirus 5 vaccine
According to Xu Jinghe, Deputy Director of the National Food and Drug Administration, currently 5 technical routes and 10 covi vaccines have been approved for clinical trials.
The aforementioned four covi vaccines, which are expected to be the first to cross the "finish line" of mass vaccination, belong to the two technical routes of inactivated vaccines and Adenovirus 5 vaccines. The remaining three technical routes also include recombinant protein vaccines, attenuated influenza virus vector vaccines, and nucleic acid vaccines.
Among them, an inactivated vaccine is a vaccine that kills the virus through physical or chemical methods, but still retains the virus's ability to cause human immune responses. The vaccine of this technical route has a long-term research foundation.
Adenovirus 5 vaccines use a modified replication-deficient adeno 5 virus as a carrier, carry the S protein gene of covi, and enter the subject to make the body produce immune memory, thereby achieving the effect of "keeping the virus out".
In addition, the covi recombinant protein vaccine jointly developed by the Institute of Microbiology of the Chinese Academy of Sciences and Anhui Zhifeilongkema Biopharmaceutical Co., Ltd., which has entered Phase II clinical trials, is to express and purify pathogen antigen proteins in engineered cells through genetic engineering to be prepared into a vaccine.
According to reports, regardless of the technical route of the vaccine, strict safety and effectiveness monitoring and evaluation will be put in the first place. Under the premise of ensuring safety, effectiveness, and scientific compliance, relevant companies will launch large-scale vaccine production capacity.
News (4)
Who is being vaccinated urgently?
The reporter learned from the Joint Prevention and Control Mechanism of the State Council that PRC has approved the "Novel Coronavirus Vaccine Emergency Use (Trial) Program" on 24 June, approved two vaccines for emergency use, and officially launched the covi vaccine on 22 July for emergency use.
Article 20 of the Vaccine Administration Law of the People’s Republic of China, which came into effect on 1 December 2019, stipulates that in the event of a particularly major public health emergency or other emergency that seriously threatens public health, the health department of the State Council needs to control and put forward recommendations for emergency use of vaccines, which can be used within a certain range and within a certain period after the organization of the State Council's drug regulatory authority has approved the discussion.
Who is being vaccinated urgently? According to Zheng Zhongwei, director of the Science and Technology Development Center of the National Health Commission, according to relevant regulations, emergency use (trial) is limited to specific groups of people who have a high risk of exposure and cannot use current effective protective measures to protect them. People who use vaccines urgently should not be taken lightly. Other protective measures and means are not reduced. Special groups such as medical personnel, epidemic prevention personnel, border inspection personnel, and personnel guaranteeing basic urban operations are the objects of emergency vaccination, which can establish an immune barrier and provide a stable guarantee for social operations.
In addition, it is reported that some overseas staff, as well as some medical staff and market staff, have also urgently vaccinated against the covi inactivated vaccine.
News (5)
How long will the vaccines be effective?
According to the results of Phase I and Phase II clinical trials that have ended, a number of covi vaccines have demonstrated good safety and antibody effectiveness.
Yang Xiaoming introduced that the two vaccines of China Biological were successively approved in April to initiate Phase I and Phase II clinical trials. The test results showed that after the two doses of vaccines, the positive conversion rate of neutralizing antibodies reached 100%.
How long can these antibodies last? The answer is still to be verified by Phase III clinical trials.
At the same time, a group of scientific researchers are collecting data on cases of infection and recovery from SARS-CoV-2 during the domestic outbreak, analyzing the duration of antibodies in their bodies, and trying to answer the question of whether they will be infected with covi again from the mechanism.
According to the "Guiding Principles for Clinical Evaluation of Vaccines for Prevention of Novel Coronavirus (Trial)" issued by the Drug Evaluation Center of the State Drug Administration recently, the effectiveness of the covi vaccine is specifically proposed: The vaccine should provide protection for one year or more or provide protection for at least six months.
News (6)
Possible overlap of SARS-CoV-2 vaccine and influenza vaccine
It is reported that the SARS-CoV-2 vaccine is expected to be "two-in-one" with the seasonal flu vaccine in the future to simplify the vaccination process.
However, before the covi vaccine has been approved for marketing, many experts have called for increased flu vaccine vaccination to avoid the formation of covi and influenza infection.
Wang Chen, Dean of the Chinese Academy of Medical Sciences and Peking Union Medical College, said that the autumn and winter seasons approach, once covid merges with influenza, the differential diagnosis will be very difficult because the difficulty of isolating the population will be significantly increased, and the investment of social resources will also be significantly increased.
"The most effective way is to get the flu vaccine universally in time." Wang Chen said.
Ref:
Yan Limeng: There are serious defects in the CCP's first SARS-CoV-2 vaccine, https://staygate.blogspot.com/2020/08/yan-limeng-there-are-serious-defects-in.html
Other Refs:
Human Adenovirus 5, ScienceDirect, https://www.sciencedirect.com/topics/medicine-and-dentistry/human-adenovirus-5
Yan Limeng: Lab accident is an option that CCP wants you to believe, https://staygate.blogspot.com/2020/08/yan-limeng-lab-accident-is-option-that.html
Yan Limeng: The PLA lab purposefully released some virus sample, https://staygate.blogspot.com/2020/08/yan-limeng-pla-lab-purposefully.html
Yan Limeng: Find out how PLA lab modified Zhoushan bat coronavirus, https://staygate.blogspot.com/2020/08/yan-limeng-we-have-to-find-out-how-pla.html
Yan Limeng: HCQ, vaccines cannot work if 'lab-modified" nature of SARS-CoV-2 is disregarded, https://staygate.blogspot.com/2020/08/yan-limeng-hcq-vaccines-cannot-work-if.html
Shi Zhengli disputes bats carry SARS-CoV-2, says whole genome sequence incomplete, among other issues, https://staygate.blogspot.com/2020/08/shi-zhengli-disputes-bats-carry-sars.html
Wuhan Institiute of Viology does not have RaTG13 in the viral genome of SARS-CoV-2 which is "not natural", https://staygate.blogspot.com/2020/05/wuhan-institute-of-viology-does-not.html
Shi Zhengli worried about laboratory virus leakage, https://staygate.blogspot.com/2020/04/shi-zhengli-worried-about-laboratory.html
Shi Zhengli : Unexpect SARS-like coronavirus cross-specifies infection will occur in Wuhan, https://staygate.blogspot.com/2020/03/shi-zhengli-unexpect-that-sars-like.html
External Refs:
Human Adenovirus 5, ScienceDirect, https://www.sciencedirect.com/topics/medicine-and-dentistry/human-adenovirus-5
Bernardo Cervellera, Prof Tritto: COVID-19 was created in the Wuhan laboratory and is now in the hands of the Chinese military, http://www.asianews.it/news-en/Prof-Tritto:-COVID-19-was-created-in-the-Wuhan-laboratory-and-is-now-in-the-hands-of-the-Chinese-military-50719.html?fbclid=IwAR3XFwlekdGVKXjUYkKNi094S_qnrXnjb1SSJNzTBG7D3oMN_Zxj3cRM6q8
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