Russian scientists belatedly published the first effects of initial trials of the experimental Sputnik V vaccine, which got government approval last month, but drew strong complaints from experts that the injections had not been tested in several dozen people before. be administered more widely.
In a report published in the Lancet journal friday, vaccine developers said it gave the impression of being and provoking an antibody reaction in the other 40 people tested in the initial phase of the exam within 3 weeks.
However, the authors noted that participants were only followed for 42 days, the test pattern was small and 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 efficacy and protection of the vaccine.However, its Russian developers made some ambitious statements on Friday after presenting the effects to journalists.
Professor Alexander Gintsburg, director of the Moscow-based Gamaleya Institute that developed the vaccine with the help of the Russian Defense Ministry, told reporters that the vaccine triggers an immune reaction “sufficient” to counter any infectious dose (one person) with COVID-19. . “
“We are in a position to state that the protective effect of this vaccine will be detectable and will remain at a suitable point for 2 years or more,” Gintsburg said, without offering any evidence for this claim.
According to the Lancet report, the trials were carried out in two Russian hospitals involving healthy adults between the ages of 18 and 60, who had to self-isolate once registered for the trial. They stayed in the hospital for the first 28 days after being vaccinated.
One component of the study concerned a frozen formulation of the vaccine, while another read a lyophilized variant. The scientists said the frozen vaccine would be suitable for existing global vaccine source chains, while the freeze-dried edition can only be used in hard versions. scope areas.
Both vaccines used a modified edition of the cold-causing adenovirus, which is not unusual, to carry the peak protein genes in the coronavirus, to prepare the framework for responding if a genuine COVID-19 virus emerges.It is a generation of vaccines developed through CanSino Biologics in China and the University of Oxford and AstraZeneca of the United Kingdom.
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 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 not yet been proven.” Bar-Zeev and his colleagues said it would be the protection of any coronavirus vaccine.
“Given that vaccines are given to other healthy people and the COVID-19 pandemic, potentially everyone 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 is not randomized and is not large enough to run into rarer protection problems,” Yaqub said.
The vaccine was approved by the Russian government with wonderful fanfare on August 11. Aspiring Vladimir Putin personally broke the news on national television, saying that one of his daughters had already been vaccinated, suffered mild side effects and developed antibodies. Since then, several high-level officials have also said they took the photos, adding Moscow Mayor Sergei Sothroughanin and Defense Minister Sergei Shoigu.
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