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    Home > Medical News > Medical World News > China's new crown vaccine has been trialed in the United Arab Emirates, Brazil, as soon as September.

    China's new crown vaccine has been trialed in the United Arab Emirates, Brazil, as soon as September.

    • Last Update: 2020-08-02
    • Source: Internet
    • Author: User
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    Text . . . A total of 155 vaccines have been developed globally, 23 of which have entered the clinical trial stage.
    at least three vaccines are currently in Phase III, and at least three more have completed Phase II.
    two Chinese companies launched Phase III clinical trials in Brazil, Bangladesh and the United Arab Emirates.
    several vaccines publish edified trial data showing that they can effectively induce an immune response in the human body and are safe. How can
    vaccine semosten? The human challenge trial is a "shortcut" - healthy subjects are vaccinated and then exposed to the virus.
    but it's unethical and controversial.
    the new crown vaccine is sure to appear this year, possibly as soon as September, but the protection rate may not reach 100%.
    looking forward to it, the good news is coming, and the world is waiting for a new crown vaccine, and the pace is getting closer.
    outbreak has been six months, as of July 21, Beijing time, the global total of nearly 15 million confirmed, the death toll has exceeded 600,000.
    the United States, Brazil and India have more than 1 million confirmed cases, and are still growing rapidly.
    China, where the outbreak has already been brought under control, small-scale cluster cases are still occurring in some areas.
    vaccine sisift edacy to contain the outbreak.
    recently, several new crown vaccine programs around the world have announced positive progress. On July 21,
    , Brazil began a Phase III clinical trial of a new crown vaccine developed by Chinese pharmaceutical company Kexing, with the first batch of about 900 volunteers participating.
    the same test will be launched in Bangladesh. On June 23,
    , China Biologicals, a Chinese pharmaceutical group, announced that its Phase III clinical trial sat trial had been launched in the United Arab Emirates. On July 20,
    , The Lancet, a leading medical journal, published the results of two phase II clinical trials of vaccines in China and the United Kingdom.
    the former comes from the Chen Wei academician team and the Conchino biology, showing that the vaccine can effectively induce an immune response in the human body, and is safe.
    the vaccine had been approved for use within the Chinese military.
    the latter, from Oxford University and AstraZeneca, the vaccine is resistant to more than 1,000 subjects and stimulates a sustained immune response from antibodies and cells.
    the same day, Pfizer inc. and BioNTech released their latest developments on medRxiv, the vaccine they worked with in Germany, and the preliminary results of the Phase 1/2 trial were positive without any serious adverse events.
    last week, the New England Journal of Medicine published the Results of the Moderna Vaccine Phase I, which induced an expected immune response in all 45 subjects after receiving two doses of the vaccine and were generally safe and well tolerated.
    vaccine sits on the market as soon as September, and it's not far off. What does
    newly released clinical trial results mean? As with the drug development process, vaccines require phase III clinical trials as a preventive vaccine (which is usually classified as both preventive and therapeutic) and is targeted at healthy populations. Phase
    Phase I typically requires 20-80 subjects to determine the type and extent of the immune response caused by the vaccine to assess the safety of the vaccine.
    Phase II study on the safety, immunogenicity, recommended dose, immunization program, and vaccination methods of candidate vaccines, with a group of hundreds of participants.
    Phase III trials ranged from 3,000 to tens of thousands of people, with a key goal to assess the safety and effectiveness of vaccines.
    the latest release of Phase II trial results for several candidate vaccines, positive results demonstrate the safety of these candidate vaccines and their ability to induce immune responses.
    as to whether the vaccine will eventually be effective, a biomedical doctor involved in the development of the new crown vaccine told The Eighth Health: 'It's too early to draw conclusions and wait for the clinical results of Phase III.
    but from the conclusions that have been released so far, we can still see some of the characteristics of the new crown vaccine.
    , for example, in the Ad5 adeno vector vaccine developed by Chen Wei's team/Conchino in collaboration, pre-existing immunity of aD5 vector remains a problem;
    the vaccine uses recombinant viral vector technology, i.e. a non-replicated antivirus as a vector, the use of a copy defective human type 5 adenovirus (Ad5), carrying the genetic material of the new coronavirus S protein, into human cells to synthesize and express the new coronavirus antibodies.
    Ad5 as a vector virus that has been used in a mature application, has had success in the Ebola vaccine, but it has one drawback: as a common human infection virus, many people have been infected, that is, the body pre-exists immunity against Ad5.
    that is, the vaccine may be less effective for some people.
    the authors of the paper pointed out that pre-existing immunity for Ad5 vectors and the age factors of the subjects may partially hinder the specific immune response induced by the vaccine, especially the antibody response.
    508 subjects, 266 (52%) had higher pre-immunity and 242 (48%) had lower pre-immunity.
    those with higher ad5 pre-existing immunity produced a weaker immune response, compared with about twice the level of binding and neutralizing antibodies in those with lower pre-existing immunity.
    , older subjects generally had lower immune responses and higher tolerances compared to younger groups. "Seniors are an important target population for the new coronavirus vaccine because they are at high risk of serious illness or even death associated with the new coronavirus pneumonia infection, " said Chen Wei, a
    may need an additional dose of inoculation to induce a stronger immune response in older populations, and further studies are under way to assess it.
    " three vaccines into Phase III clinical, the earliest vaccine is expected to be available in September according to WHO data, a total of 155 new vaccines in the world, of which 23 have entered the clinical trial stage.
    eight-point combing found that at least three vaccines are currently in Phase III, and at least three others have completed Phase II, which is about to enter Phase III (see figure below).
    worldwide, in addition to the two vaccines in China, which have entered the Phase III clinical phase, there are also the Oxford University/AstraZeneca collaboration recombinant adenovirus vector vaccine. on June 23,
    , China Bio, a chinese pharmaceutical group, announced that the world's first international clinical (Phase III) trial for a new crown inactivated vaccine was officially launched in the United Arab Emirates. On the same day
    , the UAE Health Minister issued a clinical trial approval document to Chinese organisms.
    As of July 22, the UAE has confirmed a total of 57,498 new crowncases, with 305 new cases added in a single day.
    According to DeepTech, The University of Hong Kong's virology expert, Kim Dong-soo, doesnot consider the UAE an ideal test site.
    because a good test site requires a large part of the population in the area to feel susceptible and the outbreak occurs right after vaccination.
    Reuters reported on July 1st that Sarah Gilbert, a professor of vaccines at The University of Oxford and a member of the new crown vaccine development team, said the team had observed in clinical trials that the vaccine produced the right immune response.
    previously, the Oxford University/AstraZeneca vaccine has launched Phase III clinical trials in the UK, US and Brazil.
    According to Japanese media on July 20, the vaccine will start Phase III clinical trials in Japan as soon as August, with the aim of starting supply next spring.
    the latest official announcement of Phase III clinical trials is Beijing Kexing Zhongwei Biotechnology Co., Ltd.
    the trial will be open to health care workers who volunteer in six Brazilian states, with about 9,000 people participating,
    previously reported.
    Brazil is the second-worst hit country after the United States, with more than 2.11 million confirmed cases (3.85 million in the U.S.) as of July 22, according to real-time data from Johns Hopkins University.
    the outbreak is particularly severe in Sao Paulo, Brazil's capital, where on July 19th it surpassed New York, the world's largest city.
    Coxing's Phase III clinical trials are in addition to Brazil, but also in Bangladesh.
    Bangladesh officials said On the 20th, has approved a potential new vaccine developed by Chinese company Kexing to start a third phase of local trials.
    the trial will be conducted at seven hospitals in the capital Dhaka that receive new crown patients and plan to recruit 4,200 participants.
    local time on July 21, Chinese Ambassador to Bangladesh Li Zhiming said he was willing to become the first volunteer in the third phase of clinical study of the Kexing new crown vaccine Kellaifo in Bangladesh.
    the earliest expected launch date is the Oxford/AstraZeneca vaccine.
    mid-June, Professor John Bell, who led the testing of the new coronavirus vaccine at Oxford University, said the vaccine could be available as early as the end of September 2020 and expected to be fully available in the UK over the Christmas period.
    and China's CDC director Gao Fu said in an earlier interview that China may have a new vaccine for emergency use in September, such as in the event of a recurrence of the disease for health care workers, is expected to be used early next year for healthy people.
    accelerated approach to research: in the context of the global pandemic of human challenge experiments, the development of the new crown vaccine broke with the 8-10-year long-cycle practice, and at the beginning of the outbreak WHO predicted that 12-18 months later, vaccines would be available, even faster at the current pace.
    countries are ready to accelerate sprints when they invest in vaccine research and development.
    many projects in Phase II clinical trials at the same time to start phase III clinical trials of subject recruitment and reagent production, and when The Phase II clinical trial spent, it has invested a lot of resources to prepare for large-scale production.
    in addition to the follow-up research and development process ahead of time, not to market, first production, how can the vaccine speed up? The Human Challenge Trial (HCT, human challenge trial) is a "shortcut" - allowing healthy subjects to be vaccinated and exposed to viruses to test the level of protection the vaccine provides.
    the operation of the traditional Phase III clinical trial was to inject the vaccine into the trial group and placebo to the control group, in a double-blind trial, the subjects did not know whether they were vaccinated, and then began to live a normal life, and finally the low infection rate of the trial group and the high infection rate of the control group were required to verify the effectiveness of the vaccine.
    to prove effectiveness, the trial must be conducted in areas with a large virus stock and uncontrolled outbreaks to ensure that subjects have access to the virus, since only a small percentage of the participants are likely to be infected with the virus, the trial requires a large number of subjects.
    relatively, human challenge trials are like a simplified and ideal way to experiment, can be conducted in the laboratory, within a few weeks to get results, and require smaller numbers of subjects.
    but the problem is that exposing people directly to the virus is unethical and controversial.
    an open letter to Francis Collins, president of the National Institutes of Health (NIH), a U.S. organization founded in April 2020, called Day Sooner, suggesting that human-challenging trials would significantly accelerate the development of new crown vaccines.
    signed the open letter with 15 Nobel laureates, more than 100 distinguished figures and more than 2,000 volunteers, and the organization has so far recruited 32,000 volunteers from 140 countries.
    Human challenge trials are not a new concept, according to 1 Day Sooners, a method used in the development of vaccines for smallpox, influenza, cholera, malaria, typhoid fever, dengue and Zika.
    WHO also released guidelines in May to support the use of such trials in the development of new crown vaccines.
    in terms of fatality data, Day Sooner says the new coronavirus is not harmful, especially among young people with lower mortality rates.
    , according to the medical journal The Lancet, people aged 20-29 have an unlimited risk of death from the new coronavirus, which is about the same as the risk of donating kidneys.
    In 1 Day Sooner's view, choosing people who are relatively young and have no potential health problems can minimize the risk of trials.
    Professor Adrian Hill, director of the Jenner Institute at Oxford University, one of the signatories of the open letter, told the Guardian that scientists were already preparing the experiment, with the goal of starting and working by the end of the year.
    ", "this may be parallel, or it may be after the completion of the third phase of the experiment."
    they are not competing choices, but complementary.
    "it is understood that the Oxford/AstraZeneca and Moderna vaccine projects are considering using this method.
    Source: 1 DAY SOONER Can Solve the Problem with a Vaccine? On the evening of July 20th, Professor Zhang Wenhong, director of the infection department at Huashan Hospital affiliated with Fudan University, said in a live broadcast that the new crown vaccine would definitely appear this year, but the protection rate might not reach 100%.
    has a vaccine that's going to be great? "If you look at the flu vaccine, the protection rate is generally 60 to 70 percent, " Mr. Zhang warned.
    so have a vaccine, not to say that it can be completely back to normal, but also to see how high the protection rate, how many people are vaccinated and so on.
    " Zhang Wenhong believes that due to the new crown virus "spread widely, severe symptoms, easy to cause the run of medical resources" characteristics, the new crown vaccine may need mandatory vaccination in the future.
    China's flu vaccination rate is less than 2%, so it is debatable how the new crown vaccine will be vaccinated.
    " but one thing is certain, is that high-risk groups must play, often travel people must play.
    " July 17 thin group medicine and public health forum, China CDC immunization program chief expert Wang Huaqing pointed out that in the future to develop a new crown immunization strategy, the first clear purpose is to reduce deaths, reduce outbreaks, or protect key units of the focus of the population.
    second, it is necessary to develop a series of programmes, combining the characteristics of epidemiology and vaccine effectiveness and safety, taking into account policy and feasibility, and to develop them.
    This article is an English version of an article which is originally in the Chinese language on and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

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