MOSCOW (AP) – Russian scientists belatedly revealed the first effects of early trials of the experimental Sputnik V vaccine, which gained government approval last month, but generated widespread complaints from experts, as injections were tested only on dozens of other people before being more widely disseminated.
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 protective trial referred only to men and the test focused primarily on others in their twenties and thirties, so it’s hard to know how the vaccine can appear in older populations with the threat of more severe COVID-19 headaches.
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 willing to say that the protective effect of this vaccine will be detectable and will remain at an appropriate point for 2 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 to react 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 by destroying 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 accompanying comment, Dr. Naor Bar-Zeev of the Johns Hopkins Bloomberg School of Public Health and colleagues wrote that the studies were “encouraging but modest.” They said that the immune reaction triggered by the vaccine “bodes well” but that “The efficacy of any COVID-19 vaccine has yet to be 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 Scientific Policy Research Unit at the University of Sussex, said the limited duration of the exam is not sufficient 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 isn’t random and isn’t big enough to run into rarer protection issues,” Yaqub said.
The vaccine was approved through the Russian government with a wonderful fanfare on August 11.Suitor Vladimir Putin personally announced the news on national television and said one of his daughters had already been vaccinated, 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 argued that vaccination of at-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 British University of Southampton, agreed that the Russian vaccine gave the impression of “promising”, but that additional 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.
Last month, many public fitness experts expressed fear that Russia would have 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 it had “no explicit data on Russia … and who stores what (data) with whom. ” She said the agency’s purpose is “to bring together all the countries and data.”
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Cheng reported from London, and James Keaten in Geneva contributed to this report.
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