Russian scientists belatedly published the first effects of the first trials of the experimental Sputnik V vaccine, which won government approval last month but drew widespread complaints from experts that the shots had only been tested on several dozen people before being administered more widely.
In a report published Friday in the journal Lancet, the vaccine’s developers said it appeared and would cause an antibody reaction in the other 40 people tested in the second phase of the study within three weeks.
However, the authors noted that participants were only followed for 42 days, the examination pattern was small, and no placebo or vaccine was used.
Part of the protective trial included only men and the study mainly involved other people in their 20s and 30s. It’s unclear how the vaccine might work in older populations at higher risk for more severe COVID-19 headaches.
International experts remain suspicious of the vaccine’s efficacy and protection. However, its Russian developers made ambitious statements on Friday after presenting its effects to journalists.
Professor Alexander Gintsburg, director of the Moscow-based Gamaleya Institute, which developed the vaccine with help from the Russian Defense Ministry, told reporters that the vaccine triggers an immune reaction “sufficient” to thwart any infecting dose (at a person) with COVID. -19. “»
“We are willing to assert that the protective effect of this vaccine will be detectable and remain at an appropriate point for two years or more,” Gintsburg said, without offering any evidence to support this claim.
According to the Lancet report, the trials were conducted in two Russian hospitals and focused on healthy adults between the ages of 18 and 60, who were asked to isolate themselves once enrolled in the trial. They remained in the hospital for the first 28 days after being vaccinated.
Part of the study focused on frozen formulations of the vaccine, while a freeze-dried variant was studied. Scientists said the frozen vaccine would be suitable for existing global supply chains, while the freeze-dried edition could only be used in hard-to-reach places. Areas.
Both vaccines used a modified version of the adenovirus that causes ordinary blood to generate genes for the coronavirus’s spike protein, to prepare the system to respond if an actual virus that causes COVID-19 emerged. This is a generation comparable to that of the vaccines developed by the Chinese company CanSino Biologics, the British University of Oxford and AstraZeneca.
The Russian researchers said that the 40 participants produced a reaction of neutralizing antibodies, molecules that are essential to block infection. Vaccines also appear to trigger a reaction in the body’s T cells, which destroy cells invaded by the virus.
The maximum side effects reported were pain at the injection site, fever, headache, and muscle or joint pain.
In an accompanying commentary, Dr. Naor Bar-Zeev of the Johns Hopkins Bloomberg School of Public Health and colleagues wrote that the studies were “encouraging but limited. “They said the immune reaction caused by the vaccine “bodes well,” but “the efficacy of a COVID-19 vaccine has yet to be proven. “Bar-Zeev and his colleagues said it would be the protection of any coronavirus vaccine.
“Given that vaccines are administered to other healthy people and to the COVID-19 pandemic, potentially to everyone after their approval following (advanced) trials, protection is paramount,” the scientists wrote.
Dr Ohid Yaqub, senior lecturer at the University of Sussex’s Science Policy Research Unit, said the limited duration of the study is not long enough for regulatory approval, which the vaccine won last month.
“The design and duration of a (first) study are not sufficient to meet widely identified approval criteria. The study was not randomized or large enough to run into rarer safety issues,” Yaqub said.
The vaccine was approved with great fanfare by the Russian government on August 11. President Vladimir Putin personally announced the news on national television, saying one of his daughters had already been vaccinated, had experienced mild side effects and had developed antibodies. Since then, several senior officials have also said they took the photographs, including Moscow Mayor Sergei Sothroughanin and Defense Minister Sergei Shoigu.
The Supreme Court will resume its hearing on the 2024 NTA NEET UG petitions on July 22. During the last hearing, the court questioned the distribution of the consultation documents and noted that it should not yet undermine the importance of NEETs for monetary gain. Possible paper leakage scenarios were also discussed.