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    Home > Medical News > Medical World News > More than 20 countries have applied to order the first new crown vaccine announced by Russian officials, but clinical data are lacking in quality.

    More than 20 countries have applied to order the first new crown vaccine announced by Russian officials, but clinical data are lacking in quality.

    • Last Update: 2020-09-11
    • Source: Internet
    • Author: User
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    On August 11th Russian President Vladimir Putin revealed that the country's first new crown vaccine had been approved and registered with the Ministry of Health that morning, becoming the first officially approved vaccine in the world.
    know that the vaccine is quite effective and can create a stable immunity, " Mr Putin said.
    I reiterate that the vaccine has passed all necessary tests.
    one of my daughters has tried a new crown vaccine.
    she feels good now.
    we need to mass produce a Russian vaccine for the new coronavirus in the near future.
    " According to the Russian State Drug Registration Network, the vaccine officially entered the field of civilian circulation on January 1, 2021.
    the vaccine has been named Sputnik V to commemorate Sputnik V, the first satellite launched by the Soviet Union, according to UNIS.
    The vaccine was jointly developed by the Russian State-owned Centre for Epidemiology and Microbiology of The Ministry of Defence and the 48th Central Research Institute of the Ministry of Defence for the adenovirus vector vaccine, using two different viral vectors expressing the new coronary S protein in two injections, the first is the adenovirus vector 26 vaccine, the second shot is the adenovirus vector 5 vaccine.
    the former is similar to a new crown vaccine developed in the United States, and the latter is similar to the chinese Chen Wei/Consino vaccine.
    Kirill Dmitriev, president of russia's sovereign wealth fund (RDIF), which funds vaccine research and development, said the vaccine was in fact an improved version of the Middle East Respiratory Syndrome vaccine, both based on the Ebola vaccine developed five years ago, and that the technology had been approved.
    The vaccine officially entered clinical trials on June 18, and early clinical data from the Russian vaccine showed that each of the 76 volunteers who were vaccinated kept a "volunteer diary" of the side effects mentioned: fever, rash, redness at the injection site, etc.
    Gintsburg, head of the Camarlej Institute, which claims to have been vaccinated, also said the first round of tests showed no side effects other than chilling and pan-infrared injection areas.
    Russian Health Minister Murashko said that after WHO declared a new coronavirus pandemic, the Russian research center immediately began to develop vaccines.
    Russian scientists used their own experience and sophisticated technology to make adenovirus vector vaccine.
    whether similar vaccines are registered in other countries around the world, Mr Murashko said similar studies had been conducted in China and other countries, but clinical trials were still under way.
    the new vaccine in Russia showed high efficiency and safety based on clinical trial results, with all volunteers producing antibodies and no serious side effects.
    The vaccine is not yet in Phase III clinical phase and has not yet started Phase III clinical trials, Andy Murashko said the vaccine is eligible for registration and will continue to be tested in clinical trials involving thousands of people and will be recalled at any time if any potential hazards are identified.
    Phase III clinical trials will be launched on August 12 after registration, with simultaneous trials in Russia, Saudi Arabia and the United Arab Emirates, and possibly Brazil.
    According to Anatoly Altstein, a professor at the Centre for Epidemiology and Microbiology Atletics Research in Gamelea, thousands of people will be vaccinated and monitored during the phase III trial, and it is important to note that vaccinated people need to live in an environment where the new coronavirus is present to accurately test the safety and effectiveness of the vaccine.
    expect medical staff to be the first to be vaccinated against the Russian government from occupations at risk of contracting the new coronavirus, which is expected to begin in late August or early September.
    said doctors, teachers and high-risk groups will be the first to be vaccinated, with tens of thousands of people expected to be vaccinated this month, and the research and development team will continue to track their status.
    if all goes well, mass production will begin in September and mass vaccinations will begin the next month.
    earlier, Murashko had said that the crown vaccine will be developed after the success of free vaccination for the Russian people, and according to the Russian National Drug Registration Network, the vaccine officially entered the field of civilian circulation on January 1, 2021.
    that is, older people and others are likely to start mass vaccinations next year.
    Altstein, a professor at the Center for Epidemiology and Microbiology at the University of London, said clinical trials were needed to make the vaccine world-wide.
    thousands of people must be vaccinated and monitored during the phase III trial.
    be aware that vaccinated people need to live in an environment where new coronavirus is present to accurately test the safety and effectiveness of the vaccine.
    the vaccine will not be widely used in the population until January 1, 2021, unless the government formally orders that certain people be vaccinated first.
    addition, Mr Murashko said Russia was currently developing a special tracking app that would allow Russian citizens to confirm their health and would monitor for those vaccinated for possible adverse reactions to the drug.
    russian officials declared the world's first new crown vaccine, there are many doubts about the vaccine, mainly because of the lack of clinical data on the vaccine.
    First, it was mentioned earlier that the vaccine was actually an improved version of the Middle East Respiratory Syndrome vaccine, both based on the Ebola vaccine developed five years ago, but neither Of the two Russian-mandated Ebola vaccines is widely used in Africa, according to the Associated Press.
    as of 2019, the two vaccines are listed only as "candidates" by the World Health Organization.
    is the lack of phase III clinical.
    July 31, 2020, 26 vaccine candidates worldwide are in clinical trials, according to the World Health Organization.
    of these, only 6 vaccines have successfully entered clinical Phase III trials, with China accounting for 3 seats, the United States, the United Kingdom, Germany, Russia is currently the only vaccine entering the clinical trial phase, still in Phase II status.
    , the vaccine was tested in only 76 clinical Phase II trials.
    were given liquid vaccines and half soluble powder vaccines in two groups.
    such clinical trials can verify that the vaccine induces the production of antibodies and serious adverse reactions, it is difficult to know for sure whether the vaccine provides immune protection.
    Phase III clinical is the last step in the development of new drugs, but also a critical step, if the phase III clinical skip, will introduce uncertainty about the efficacy and safety of the drug.
    Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases and a top infectious disease expert, said in a media interview Monday that developing a vaccine and proving it safe and effective are two different things.
    that he does not have any evidence to show that the Russian vaccine is safe and reliable.
    , however, according to the Global Times, Yang Zhanqiu, a professor at the Institute of Virus Research at Wuhan University's School of Medicine's School of Basic Medicine, said that a year and a half of research and development cycle is already relatively fast in terms of the general law of vaccine development.
    from January this year to now, it has been about 8 months, the safety and effectiveness of the vaccine through more than half a year should be said to be able to initially resolve.
    not solve the problem, Russia should and will not be afraid to release the news, saying only that Russia has accelerated the transition from laboratory research to commercialization.
    In addition, the Russian Association of Clinical Research Organizations called on the Russian Ministry of Health to put forward a proposal to delay the national registration of the first batch of vaccines developed in Russia until the third phase of clinical trials was successfully completed, while pharmaceutical companies called on the Russian Ministry of Health to delay the registration of the vaccine.
    , the chief external epidemiologist at the Russian Ministry of Health, Nikolay S. Bricoe said the technology used in the vaccine had been used in the development of other vaccines before, and there was no need to delay the registration of the vaccine.
    vaccines have not emerged out of the sky, and the center has been working in this direction for more than a decade to develop vaccines against viruses such as Ebola.
    adenovirus vector technology was also used in the development of the new coronavirus vaccine, which already exists.
    particularly important is that the vaccine has passed the relevant research stage.
    these stages are very strict, more stringent than when developing drugs.
    given the emergency caused by the new crown outbreak, registration can be accelerated, as post-registration regulation helps evaluate the long-term safety and effectiveness of the vaccine.
    said foreign criticism of vaccines was baseless and motivated by fears of fair competition.
    WHO is discussing the prequalification process based on the current situation, WHO spokesman said on the 11th, WHO and Russian health authorities are discussing the newly approved coronary vaccine may be pre-qualification procedures.
    "We are in close contact with the Russian health authorities and discussions are ongoing on WHO's pre-vaccine issues, but the prequality of any vaccine includes rigorous review and evaluation of all necessary safety and ability data.
    "Production will reach millions of doses per month early next year, and production of the vaccine is now available in two locations: the National Research Center for Epidemiology and Microbiology in Carmarea and Binnopharm.
    , Russia is working on the technical regulations needed to expand production.
    Direct Investment Fund is responsible for investment in vaccine production and overseas promotion.
    , Russia's minister of industry and trade, has previously said the country's vaccine production capacity will reach millions of doses a month by early next year.
    addition, Erge Cagliado, director of the Technical Institute of the Brazilian state of Parana, announced on August 11th that the state government of Parana would sign an agreement with Russia to produce a new crown vaccine.
    the agreement, Russia will produce the world's first new crown vaccine registered on the 11th in the southern Brazilian state of Parana.
    , in fact, talks between Parana and Russia on vaccine production have been going on since July, according to foreign media.
    state submitted a letter of intent to the Russian ambassador to make the new crown vaccine, but the vaccine has not yet completed all trials.
    brazil has become a centre for vaccine testing and production, one of the main reasons for the continued increase in infections in the country over the past five months.
    more than 20 countries have applied to order more than 1 billion doses of the vaccine, according to Russian media reports, Russia's sovereign wealth fund (RDIF) said it had received more than 20 countries to buy Russia's new crown vaccine.
    have received initial requests from more than 20 countries to purchase more than 1 billion doses of Russian vaccine, " said Mr Dmitriev.
    we have signed vaccine production agreements with five countries and now have the capacity to produce 500 million doses of the vaccine in the next 12 months.
    may be the first to start vaccine production in Cuba in November.
    Cuba could become one of the main centres for vaccine production.
    " at the same time, Philippine President Duterte said in a televised address to the nation on the 11th, voluntarily became the first person to personally test Russia's new crown vaccine.
    , Serbian President Vucic said his country was ready to become the first country to receive the Russian vaccine.
    , regardless of current public opinion, Russia has not yet published data on specific clinical trials related to the vaccine on any academic platform.
    interjected, just after Russia announced "significant progress" in the new crown vaccine, U.S. President Donald Trump announced that the U.S. government would order 100 million doses of the experimental new crown vaccine ,mRNA-1273 from Moderna.
    Attached: National New Crown Vaccine Research and Development Progress China: Three New Crown Vaccines Enter Phase III Clinical Trials U.S.: FDA May Approve a Vaccine Italy in November: August 24 Launches Domestic New Crown Vaccine Human Trials UK: Oxford University New Crown Vaccine Enters Phase III Turkey: New Crown Vaccine Will Begin Clinical Trials Australia: New Crown Vaccine Human Trials Phase 1 Through Kazakhstan: Domestic Vaccines Begin Clinical Trials India: First New Coronary Vaccine Enters Clinical Trials.
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