Russia has completed clinical trials of its first coronavirus vaccine. It is expected to be approved soon, after which mass vaccination will begin in October, according to Health Minister Mikhail Murashko. The vaccine was developed by scientists at the N.F. Gamaleya National Research Center for Epidemiology and Microbiology.
Several other vaccines are under development, the minister said. “The first vaccine against coronavirus, developed by the Gamaleya Institute, has completed clinical trials and is now preparing a package of documents for the registration procedure. Another vaccine is undergoing clinical trials, and we expect at least two more applications in the next one and a half to two months to obtain permission to conduct clinical trials,” Murashko was quoted by RIA Novosti.
According to the head of the Ministry of Health, mass vaccination may begin in Russia in October, but first special groups of people will be vaccinated – health care workers, teachers and those who are constantly in contact with large groups of people. Earlier, Russian authorities reported that the vaccination would be free of charge.
Russia’s rapid success in producing a coronavirus vaccine was met with skepticism in the United States and Europe. Both the media and health officials have expressed doubts about the Russian vaccine. They are concerned that clinical trials may have been conducted in violation of regulations in an attempt to win the vaccine race against other countries. Since Russia has not published scientific data on vaccine trials, it is impossible to verify this. At a U.S. congressional hearing on Friday, leading infectious disease expert Dr. Anthony Fauci expressed doubt that the vaccine trials in Russia and China were conducted properly because of how quickly they were completed.
In April, Russian President Vladimir Putin ordered the government to make decisions aimed at simplifying and shortening the time needed to conduct preclinical and clinical trials, as well as state registration, of drugs for the prevention of coronavirus. We explain quickly, simply, and clearly what happened, why it matters, and what happens next.
Russia’s first anti-coronavirus vaccine was developed by scientists at the Gamaleya Institute in cooperation with the Ministry of Defense, and in mid-July the military department announced the successful completion of trials on volunteers at the Burdenko Military Hospital. “At the time of issuance, all volunteers, without exception, who received immunity to the coronavirus, felt normal. Thus, the first domestic vaccine against the new coronavirus infection is ready,” said Ruslan Tsalykov, First Deputy Defense Minister, explaining that mass production is planned to start in August immediately after approval. The Department of Defense emphasized that the results of the analysis clearly demonstrate the development of an immune response in all volunteers, without any side effects, complications or adverse reactions. No health complaints were noted.
The other day, Deputy Prime Minister Tatyana Golikova said that this vaccine is one of the two most promising. “In August 2020, its state registration is planned under certain conditions, which include conducting a clinical trial on 1,600 people after registration. The start of industrial production is expected in September 2020,” Golikova said.
There are also doubts within the scientific community about the safety of the vaccine. “As I said, vaccination will start with high-risk groups. And if doctors are an obvious high-risk group, then of course teachers are out of luck in this case. Justifying the vaccination of doctors with an untested vaccine can be done somehow, but for unrelated teachers it is already impossible. And the main thing is that these will not be full-fledged clinical trials, because they will simply administer the vaccine and see what happens, without any proper analysis and comparison,” writes scientific journalist Irina Yakutenko in a “Telegram” channel.
The talk is apparently about a so-called “vector vaccine” based on DNA adenovirus with the embedded genome of the SARS-CoV-2 coronavirus. The adenovirus acts as a courier, delivering the coronavirus gene into cells, where it initiates the synthesis of coronavirus envelope proteins and introduces them to the immune system.
In May, it was reported that scientists at the Gamaleya Institute had carried out self-vaccination as a first step, even at the stage of testing the vaccine on animals, drawing criticism from the Association of Clinical Research Organizations (AOKI) and accusations of violating the norms of conducting clinical trials. However, the director of the institute, Alexander Gintsburg, explained that the center’s employees took an experimental drug “to continue their research during the pandemic without the risk of infection,” noting that no side effects were detected in the scientists.
In mid-July, reports surfaced that some members of Russia’s elite had allegedly gained access to the Russian Gamaleya Institute’s coronavirus vaccine in April, before the spike in infections in May. However, both the institute’s administration and representatives of the Ministry of Health denied this.
It is also known that the Russian company “R-Pharm”, one of the largest Russian distributors and manufacturers of pharmaceuticals, has concluded an agreement with the British-Swedish pharmaceutical giant AstraZeneca for the supply to Russia and other countries of a vaccine developed at the University of Oxford. The AstroZeneca vaccine, developed by the University of Oxford, has a similar mechanism of action to the Russian vaccine, but the British vaccine was closer to completion: the third phase of the trial began in July, when the vaccine was administered to large groups of volunteers. However, UK authorities have repeatedly stated that mass vaccination is unlikely to begin before 2021 under any scenario.