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Last month, Russian media reported that the Sputnik V vaccine developed in that country (in an attempt to link to a Soviet-era space satellite launched in 1957) had already been approved for use.
Western scientists are concerned about such urgency on the part of the Russian pharmaceutical authorities: no data has been released proving the safety of the vaccine from publicly available sources. Therefore, some experts have warned that too hasty efforts to develop a vaccine could be dangerous.
Russia has rejected any criticism from the international scientific community as an attempt to undermine Moscow’s research. Meanwhile, representatives of the Russian Fund for Direct Investment claimed that the publication of the first article on the vaccine in The Lancet justified it, as it turned out that the patients had developed antibodies “without serious side effects.”
An article published in The Lancet reviews two small-scale studies. Each was cared for by 38 healthy adults between the ages of 18 and 60. They were immunized with two injections.
The time difference between the first and second doses of the vaccine is 21 days.
In total, the patients were followed for 42 days. All developed antibodies against SARS-CoV-2 during the first three weeks of the study.
The report said the data showed the vaccine was “safe, well tolerated, and did not cause serious side effects in healthy adult volunteers.”
The studies were neither randomized nor blinded. This means that they were not placebo controlled and the patients knew that they were receiving the study vaccine and that they were certainly not randomized to the control group.
The researchers emphasized that larger, longer-lasting studies, including a placebo comparison, were needed to determine the long-term safety of a vaccine designed to protect against COVID-19.
The Lancet article states that the 76 subjects will be followed for a maximum of 180 days, adding that more comprehensive phase III clinical trials are planned with 40,000 volunteers “of different ages and risk groups.”
“A powerful answer for skeptics”
Kirill Dmitryev, head of the Russian direct investment fund that financed the vaccine, told reporters at a remote press conference in Moscow that The Lancet’s publication was “a powerful response to skeptics who have improperly criticized the Russian vaccine.” .
But independent experts are not yet convinced of such a claim.
Naor Bar-Zeev, a researcher at the Johns Hopkins School of Public Health (USA) who does not belong to any vaccine development group, said the study described in The Lancet was “promising but small” and added that it did not show efficacy in elderly patients who are particularly susceptible to infection by the new coronavirus.
“The key to COVID-19 vaccines will be to demonstrate safety. This is important not only for people to accept this vaccine, but also for general confidence in vaccines. Because vaccines are given to healthy people and during COVID-19 pandemic, safety is of utmost importance for its massive application after successful phase III clinical trials, “the American researcher told The Lancet.
The pandemic has led to the mobilization of funds for research on an unprecedented scale, and all phases of research have been carried out at an incredible pace to develop a vaccine that can protect billions of people around the world. planet as fast as possible.
Russia’s goal is international trade
Russian representatives say industrial production of its vaccine is expected to begin in September.
In mid-August, Russian President Vladimir Putin said the vaccine was creating “long-term immunity” and that one of his daughters had already been vaccinated. But at the same time, the Russian health minister said clinical trials of the vaccine have not been completed.
The World Health Organization has asked Russia to follow standard guidelines for testing pharmaceuticals and to “follow all steps” to ensure that the developed vaccine is safe.
The Sputnik V vaccine was developed by researchers at the Gamalaya Institute for Epidemiological and Microbiological Research in coordination with the Russian Ministry of Defense.
The researchers used an adenovirus that causes the common cold as the basis for the vaccine, which was modified to bind a genetic fragment of the novel SARS-CoV-2 coronavirus.
The study’s lead author, Denis Logunov, a researcher at the Gamalea Institute, claimed that the adenovirus-based vaccine enters human cells and carries a genetic fragment that encodes the SARS-CoV-2 needle, which helps the immune system to ” recognize and attack the virus. “
Dmitrijev stated that “initially the vaccine will be destined for the Russian market, but we hope to be able to present it on the international market as well.” According to him, interest in this vaccine has already been expressed by some 40 states.
The WHO claims that it will never approve a vaccine for which there is no evidence of safety and efficacy and has also stated that it does not expect that by 2021. It will be possible to start large-scale vaccination against the new coronavirus in mid-
The WHO indicates that 176 studies of possible vaccines are currently underway, including 34 drugs that have already reached the human phase. Of these, 8 products have reached the third furthest phase of clinical trials.
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