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Russian scientists belatedly published the first effects of initial trials on the experimental Sputnik V coronavirus vaccine, which got government approval last month, but sparked widespread complaints from experts, as the injections were tested in only dozens of other people before being administered more widely.
In a report published Friday in Lancet magazine, the vaccine’s developers said it gave the impression of being safe and causing an antibody reaction in the other 40 people tested in the test phase within 3 weeks.participants were only followed for 42 days, that the test pattern was small and that no placebo or vaccine was used.
Part of the protection trial focused on men only, and the review basically focused on other people in their twenties and thirties, so it is difficult to know how the vaccine can appear in older populations at most with the threat of more headaches. severe COVID-19.
International experts have remained cautious about the effectiveness and protection of the vaccine, however, its Russian developers made ambitious statements Friday after presenting the effects to journalists.
Professor Alexander Gintsburg, director of the Moscow-based Gamaleya Institute who developed the vaccine with the help of the Russian Ministry of Defense, told reporters that the vaccine triggers a “sufficient” immune reaction to counteract any dose that infects (a person) with COVID-19..”
“We are ready to say that the protective effect of this vaccine will be detectable and will remain at an appropriate point for two years or more,” Gintsburg said, without offering any evidence of this claim.
According to Lancet’s report, trials were conducted in two Russian hospitals involving healthy adults between the age of 18 and 60, who had to self-insulate once registered for the trial and remained in the hospital for the first 28 days after being vaccinated.
One component of the study concerned a frozen formula of the vaccine, while another read a freeze-dried variant. Scientists said the frozen vaccine would be suitable for existing global vaccine source chains, while freeze-dried editing can only be used in harsh versions.range areas.
Both vaccines used a modified edition of the common cold-causing adenovirus to bring complex protein genes to the coronavirus, in order to initiate the framework for reacting if a genuine COVID-19 virus occurs.It’s a vaccine-like generation, evolved through CanSino Biologics in China and the British University of Oxford and AstraZeneca.
Russian researchers said the 40 participants produced a response of neutralizing antibodies, molecules essential to block infection.Vaccines also appear to cause a reaction in the body’s T cells, which destroy cells that have been invaded by the virus.
The maximum side effects reported were injection site pain, fever, headache and muscle or joint pain.
In an adjunct commentary, Dr. Naor Bar-Zeev of the Johns Hopkins Bloomberg School of Public Health and his colleagues wrote that the studies were “encouraging but modest.”They said the immune reaction caused by the vaccine “bodes well,” but that “The effectiveness of any COVID-19 vaccine has still been demonstrated.”
Bar-Zeev and his colleagues said it would be the protection of any coronavirus vaccine.
“Since vaccines are given to other healthy people and the COVID-19 pandemic, potentially all after approval after (advanced) trials, protection is paramount,” the scientists wrote.
Dr Ohid Yaqub, Senior Lecturer in the Science Policy Research Unit at the University of Sussex, said the limited length of the review is not long enough for regulatory approval, which the vaccine won last month.
“The design and duration of an exam (early) is far from sufficient for widely identified approval standards.The test is not randomized and is not large enough to run into rarer protection problems,” Yaqub said.
The vaccine passed through the Russian government with great fanfare on August 11.Suitor Vladimir Putin personally announced the news on national television and said that one of his daughters had already been vaccinated, had suffered mild side effects and developed antibodies.Level officials have also said they took the photos, adding Moscow Mayor Sergei Sobianin and Defense Minister Sergei Shoigu.
It is known whether they were among the volunteers affected in clinical trials or whether they accessed the vaccine in any other way.
The Russian fitness government last month announced complex trials of the vaccine among 40,000 volunteers. According to official records, this will be a randomized, double-blind, placebo-controlled study. Officials also discussed that vaccination of risk groups, such as doctors and teachers, can be carried out “in parallel” – however, it is still known whether it will be carried out as a component of the study.
Michael Head, principal global fitness researcher at the University of Southampton in the UK, agreed that the Russian vaccine was “promising,” but more studies were needed.
“At this point, we don’t know if the vaccine is working,” he said.Head was not similar to Russian research.” Public confidence in any vaccine is vital,” he said in a statement, asking the Russian government and others to recommend that a vaccine be accelerated without proper “problematic” research.
“At the end of the day, we don’t have to pour extra fuel into the fires in the vaccine lobby,” he said.
Many public fitness experts expressed their fear last month that Russia had approved the Sputnik V vaccine before releasing data.
The World Health Organization said last month that it had started talks with Russia to get more important points about its vaccine candidate, but on Friday, WHO spokeswoman Dr Margaret Harris said she “had no express data on Russia…and who stores what (data) with whom.” She said the agency’s purpose “is to collect all countries and collect all the data.”