First modification: 08/09/2020 – 17:14
The first human trials of Sputnik V, the Russian vaccine against Covid-19, had encouraging results. But the conclusions, published on Saturday in ‘The Lancet’, are still considered insufficient to justify the decision of Russian President Vladimir Putin to authorize its use on a large scale.
It is already possible to increase the scientific seriousness in the debate around Sputnik V, the controversial Russian vaccine against Covid. 19. Researchers from the Gamaleya National Center for Epidemiology and Microbiology in Moscow, responsible for its development, finally made public the first results of clinical trials carried out in humans in the scientific journal ‘The Lancet’, on Saturday 5 September.
A long-awaited article since Russian President Vladimir Putin’s surprising decision to give the green light, on August 11, to the use of this vaccine on a large scale. This announcement took the international scientific community by surprise because there was no data to independently assess the effectiveness of Sputnik V. The researchers feared that scientific rigor had been sacrificed for the importance of the media and political coup: the vaccine Russia became, in effect, the first in the world whose use had been officially authorized by a government.
“So far so good”
The article published in ‘The Lancet’ strengthens, in part, the hopes that Moscow had on Sputnik V. “It establishes that the vaccine entails the creation of a significant amount of antibodies against Covid-19, similar to what happens after a natural contamination by the virus ”, summarizes Peter Openshaw, immunologist at Imperial College London, contacted by France 24.
The reaction of the immune system described by the Russian researchers is comparable – even slightly stronger – than that induced by the vaccine developed at Oxford, considered one of the most promising, the British scientist says.
All 76 participants in the two clinical trials, carried out by the Russian research center, developed a strong concentration of antibodies after receiving an injection of Sputnik V.
How safe is the Covid-19 vaccine announced by Russia?
The scientists also determined the absence of “notable” side effects associated with this vaccine. “So far everything is fine,” confirms Brendan Wren, infectious diseases specialist at the London School of Hygiene and Tropical Medicine, quoted by the ‘BBC’.
Was Vladimir Putin right then to claim victory in front of the whole world, assuring that “all necessary tests were carried out successfully”? It would be a bit of a rush, warns Peter Openshaw.
What about at risk populations?
First, some patients suffered severe fevers – over 39ºC – after receiving the vaccine. “Of course, if you are trying to fight a potentially deadly virus, that falls into the category of acceptable side effects, but it is not trivial either,” Peter Openshaw emphasizes.
On the other hand, Sputnik V was tested only on 76 volunteers. It is little to draw general conclusions about its effectiveness. “There were not enough participants to exclude the possibility of rare adverse effects,” says Ohid Yaqub, a specialist in experimental procedures at the University of Sussex, interviewed by the Science Media Center page.
Those volunteers were also “all under 60 years old and were, in part, military, that is to say that they are not the most susceptible people to suffer from acute forms of the disease,” says Peter Openshaw. Therefore, in this phase, the results are non-existent to evaluate how the individuals most at risk will react to this vaccine. An even more worrying lack of information because Moscow announced in late August that Sputnik V would be administered first – starting in October or November – to the elderly, ‘The Lancet’ highlights in an article.
Taken together “these results are encouraging and sufficient to undertake a phase III trial, that is, on a larger portion of the population. But at this point it would be wrong to proceed to carry out vaccines outside of a clinical protocol ”, warns Peter Openshaw.
The risk of favoring the anti-vaccine movement
On the other hand, the researchers from the Gamaleya center in Moscow indicated that they had begun the recruitment of 40,000 volunteers to confirm the effectiveness of Sputnik V. “The question is whether the political pressure exerted will make the vaccine be distributed to the general public before the results of that large-scale trial, ”says Éleanor Riley, an immunologist at the University of Edinburgh.
Moscow could be even more tempted to ignore that phase III trial as US President Donald Trump indicated that he, too, was considering bypassing certain drug validation procedures to speed up the implementation of a vaccine.
But this race to be the first considerably increases the risk of problems in the development of the cure. “Precipitation can lead to, among other things, errors in production, accidental contamination of fragments,” says Peter Openshaw.
In today’s healthcare context, this risk-taking is a luxury that the world cannot afford, scientists believe. “The public needs to have confidence in vaccine research. If we are not absolutely transparent and rigorous, we are simply favoring the anti-vaccine lobby ”, warns Michael Head, an expert in public health policy at the University of Southampton, interviewed by the British Science Media Center. In other words, wanting to be first at all costs can, in that case, cost lives.
This article was adapted from its original in French