Why is the world's first new crown vaccine approved for sale, but people do not agree?

READ MORE: Russia's world's first new crown vaccine, registered, has not received plaudits from all sides, but has drawn scious and even fierce criticism from the medical and scientific communities.
August 11, Russian President Vladimir Putin announced that Russia's first new crown vaccine, Satellite V, had been registered with the state, saying that "the vaccine is very effective, has a stable immunity and has passed all tests";
According to Russian Health Minister Mlaashko, the vaccine's Phase III clinical trial began on the 12th and will last about five months, noting that the vaccine is expected to make inoculators immune to the new coronavirus for up to two years.
Photo Source: Screenshot of Putin's live conference video However, the world's first registered new crown vaccine did not get plaudits from all sides, but attracted a lot of scum from the medical and scientific communities, and even a fierce attack on it.
Nature and Science, both of which published articles on their websites on August 11th, expressed concern about the vaccine's safety and effectiveness, while Anthony Folch, a top U.S. infectious disease expert, also expressed serious doubts about the safety and technology of Russia's new vaccine.
, a geneticist at University College London, called it "a very arbitrary and reckless decision and it is immoral to mass inoculation of untested vaccines."
" Photo Source: Why isn't the world's first nationally registered new crown vaccine recognized? Rapid success, lack of credibility Whether the FDA or China NMPA, any new drug on the market requires prequalification, including careful review, evaluation of all the necessary safety effectiveness of vaccine clinical trials.
The development of the vaccine is subject to established procedures at all stages of research and development to ensure that the final start of production of the vaccine is safe and effective, the entire approval process will take at least half a month, and it is understood that the Russian vaccine began research on June 18, I. and II clinical trials It ended on July 15th and August 3rd, respectively; on August 10th russia's Ministry of Health declared the vaccine registered, and on August 11th, just one day after Russian President Vladimir Putin announced that the vaccine had been successfully approved for national registration, it had to raise questions and alarm in the medical community.
fact, this is not the first time Russia has alarmed the international medical community around vaccines and new crowns of "antidotes".
In April this year, the Moscow Health Department received an open letter from the Association of Clinical Trial Organizations referring to the use of hydroxychloroquine as a drug use study to prevent coronavirus, forcing first-line health care workers to take the drug quantitatively to verify that it has a preventive effect on the new coronavirus.
and several changes to the implementation plan, not even according to the "clinical registration" declaration, causing controversy.
May, the Gamali Center, Russia's vaccine research and development agency, asked its research and development staff to inject themselves with a vaccine that was still in the initial stages of the trial, without acknowledging that it was a "clinical trial" and once again raising the alarm in Russia's medical community about the development of new crown drugs.
russia's new crown vaccine "satellite V" directly bypass phase III. Clinical trials were approved, but three things, the lack of credibility into inevitable, raising doubts is inevitable.
What's more, some netizens said: "For so many years, no well-known new drug, including vaccines, was first developed in Russia, partial to the new crown vaccine it was the first to develop, not that it must not be impossible, but the possibility is not high."
" Phase 3 trial has not been done, key data lack According to the World Health Organization, so far, a total of 165 new crown vaccines are in the trial stage, of which 69 are recombinant protein vaccines, 42 are virus vector vaccines, 37 are nucleic acid vaccines, 14 are inactivated vaccines, 3 are detoxifying live vaccines.
of the 165 vaccines, 28 Covid-19 candidates are in clinical development or nearing the end of the term; Joint Development, China Science and Development Corporation, Wuhan Virus Research Institute, Beijing Virus Research Institute and China Pharmaceutical Group, Moderna Corporation of the United States and the National Institute of Allergy and Infectious Diseases, and BioNTech Corporation of Germany and Fosun Pharma and Pfizer.
It's worth pondering that the vaccine approved for sale in Russia is not included in Phase III. Trials, and that Russia's new crown vaccine is still in a "clinical phase one" state, according to WHO's latest global vaccine development progress on August 10th, and is now available directly bypassing Phase III.
It's worth noting that no academic papers on the results of human trials of the New Crown vaccine in Russia have been searched, only two clinical Phase I trials of the vaccine have been published in the U.S. Clinical Trials Database;
Photo Source: Chinical Trisls The "guilty inference" or "invalid inference" put forward by the "Redsyvir III. Phase III. Clinical Trials, Presumpt of Drug Guilty" published by the Drug Intelligence Network platform may be the best interpretation - if a drug is effective, you have to come up with sufficient trial data to show its effectiveness, otherwise it will not work.
how to prove the effectiveness of a drug, there is an internationally accepted gold standard, that is, randomized, double-blind, controlled clinical trials.
it take for a new drug to be clinical from the beginning to the time it is finally proven to be effectively approved for market? The answer is 3-5 years.
is the chance of success? According to statistics less than 10%, this is still based on the effective use of animal testing.
and Russia's new crown vaccine directly did not do the key phase 3 clinical trials on the basis of a short period of 2 months to be approved for the market, the lack of new crown vaccine development details and 'accompanying data', the effect is worthy of deep study.
At a time when the global epidemic of the new crown is still shrouded, all the "antidotes" or vaccines about the new crown are urgently needed, and we look forward to the early development of special effects drugs and vaccines, but keep in mind that on the way to accelerated development, to ensure safety and effectiveness.
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