Despite the criticism that he was exposed to, it appears that the Russian vaccine, known as “Sputnik V”, is on its way to prove its effectiveness and safety, according to scientists from Moscow.
“Masrawy” reviews the latest discovery by Russian scientists about the effectiveness of the Sputnik vaccine against the emerging corona virus, according to the British newspaper, the Daily Mail.
Early studies have shown that a Russian vaccine may actually protect against infection with Corona, as Moscow finally released data on the controversial vaccine.
The Russian vaccine became the first in the world to be approved for mass use last month, with President Vladimir Putin looking to inject nationwide in October, as the move caused an uproar in the world, because there was no evidence that a vaccine called Sputnik V – worked. Or safe.
It later emerged that the British had discovered a Russian cyber attack on Oxford University scientists developing an almost identical vaccine, prompting concerns that Moscow had tried to steal research from the UK.
But the results of two clinical trials that were conducted in Moscow, and published yesterday in the popular British journal The Lancet, indicate that the vaccine is safe and effective.
The Russian scientists who conducted these studies said that the injection stimulated an immune response in all of the vaccinated participants and did not cause any serious health problems.
The production of antibodies seen in patients indicates that the vaccine was able to prepare the body to be able to fight the Covid-19 virus.
Western scientists said the results were somewhat reassuring, but they cautioned that the trials were too small and limited to warrant the injection of millions of Russians.
Only 76 people participated in the study, half of whom had already been infected, and the volunteers were all healthy and most of them were in their 20s and 30s.
Vaccines can be more dangerous in the elderly because their immune systems are too weak to fight the trace amounts of the virus in the vaccine, and because vaccination does not cause harm does not mean that it can prevent infection, as more careful research must be done to prove this.
Scientists in the United States and the United Kingdom, who were not involved in the work, said the results were encouraging and the vaccine was promising, however, they were still concerned about the quality of the research.
The research was not random, which means that it was not conducted according to the highest scientific standards and the effects of the vaccine could not be compared to the health of people who did not receive it, and the trials were conducted in two Moscow hospitals, Burdenko Hospital and Sechinov University Hospital.
Participants were between 18 and 60 years old and they were all considered healthy. In the first phase of the trial, volunteers were given a portion of the vaccine to see if they were experiencing any negative side effects. Approximately 60 percent of the participants experienced some pain in The injection site, while half of them experienced high temperatures – these are generally considered mild and tolerable effects.
Four in 10 reported head pain, a quarter of them felt weak or lack of energy, and 24 percent experienced muscle and joint pain. All of these symptoms were mild and very common in many other adenovirus vaccines, so Sputnik V was considered a safe vaccine.
Adenovirus is a pathogen known to cause the common cold and can be worked on to match the genetic sequence of SARS-CoV-2, the coronavirus that causes Covid-19.
This technology is also used in prototypes of the vaccine developed by the University of Oxford and the Chinese company CanSino, and the second phase saw the volunteers give the complete two-dose vaccine so that scientists could monitor the immune response of their bodies.
All 40 people who were vaccinated produced high levels of antibodies against Covid-19 within 28 days, which in theory, would be sufficient to fight the infection, and to analyze the level of immunity developed by each person, the scientists compared their antibody levels with blood samples taken. From patients who have already had the disease.
The authors say that antibody responses appear to be higher in vaccinated people than in those with normal immunity, and the scientists admit that their studies were limited, including that they had a short follow-up (42 days), and it was a small study, and some parts included only male volunteers. There was no placebo or control vaccine to compare it with, and they say that more research is needed to evaluate the vaccine in different groups, including older age groups, individuals with chronic diseases, and people in high-risk groups, and the vaccine will now move to Phase III trials – which will see tens of thousands of people be injected with the vaccine, and will be monitored regularly to see if it can really prevent them from contracting corona, which is still prevalent in Russia, but rigorous phase III trials usually take several months – as was the case with Oxford candidate vaccine.
The Oxford vaccine has been subject to phase III studies for more than three months, and has not yielded preliminary results yet, but Vladimir Putin, President of Russia, has pledged to provide his country’s vaccine by next month.
There is great concern about the speed of studies and concerns that the Kremlin is unlikely to admit defeat if it does not succeed in the end, as the lead author of the early studies, Professor Alexander Gentsburg, of the Aesthetic National Center for Research in Epidemiology and Microbiology in Russia said: Preclinical and clinical studies, which made it possible to temporarily approve the vaccine under the current Decree of the Government of the Russian Federation of April 3, 2020 No. 441, this provisional license requires a large-scale study, and allows vaccination in an agreed general group in the course of phase 3 of the experiment, Using the vaccine in a population that is subject to strict surveillance, and providing vaccination to high-risk groups.
He adds: “The third phase of our vaccine clinical trial was approved on August 26, 2020, and is scheduled to include 40,000 volunteers of various age groups, and it will be conducted with continuous monitoring of volunteers through an online application.”
Naor Bar-Zeev, of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, said in an editorial in The Lancet that the studies were encouraging but small.
He added: (The fact that it triggers the antibody response) bodes well, although nothing can be inferred about immunization in older age groups, and the clinical efficacy of any Covid-19 vaccine has not yet been demonstrated, “as demonstrating safety would be an order. Crucial with vaccination, not only for acceptance of the vaccine but also for confidence in vaccination on a large scale, ironically, a vaccine that reduces disease but does not prevent infection may make matters worse.