The first human tests of Sputnik V, the Russian vaccine against Covid-19, have shown encouraging results. But the results, published on Saturday in The Lancet, are still considered insufficient to justify Russian President Vladimir Putin’s decision to allow them to be used by the public.
We can now put some scientific seriousness into the debate over Sputnik V, the controversial Russian vaccine against Covid-19. Researchers from the Gamaleya National Research Center for Epidemiology and Microbiology in Moscow, which is responsible for its development, have finally published the first results of clinical trials on humans in the scientific journal The Lancet, Saturday 5 September.
An article that eagerly awaited the shocking decision of Russian President Vladimir Putin to give the green light on August 11 the use of this vaccine to the public. This announcement had surprised the international scientific community as there was no data to independently assess Sputnik V’s effectiveness. The researchers feared that scientific rigor had been sacrificed on the altar of the media and political coups: Russian vaccine actually became the first in the world, the use of which was officially approved by a government.
“So far so good”
The article published in The Lancet partly supports the hopes that Moscow has placed in Sputnik V. “It states that the vaccine causes the creation of a significant number of antibodies to Covid-19, similar to what is happening. passes after a natural contamination of the virus, ”concludes Peter Openshaw, an immunologist at the Imperial College of London, contacted by France 24.
The response of the immune system described by Russian researchers is comparable, if not stronger, than that induced by the vaccine developed at Oxford, which is considered one of the most promising, the British researcher specifies.
All 76 participants in the two clinical trials, conducted by the Russian Research Center, developed a high concentration of antibodies, after receiving an injection of Sputnik V. Researchers also concluded that there were no adverse effects “remarks” associated with this vaccine . “Until then, everything is fine,” confirms Brendan Wren, an infectious specialist at the London School of Hygiene & Tropical Medicine, quoted by the BBC.
Was it therefore right for Vladimir Putin to claim victory above all others and to ensure that “all necessary tests had been carried out successfully”? It would go very fast, warns Peter Openshaw.
How about risk populations?
First, some patients suffered from high fever, above 39 ° C, after receiving the vaccine. “Sure, if it’s to fight a potentially deadly virus, we can classify it in the category of acceptable side effects, but it’s not anecdotal either,” says Peter Openshaw.
Sputnik V has also been tested on only 76 volunteers. This is a bit to draw general conclusions about its effectiveness. “There were not enough participants to rule out the possibility of rare side effects,” said Ohid Yaqub, a specialist in experimental procedures at the University of Sussex, interviewed by Science Media Center website.
These volunteers were also “all under the age of 60 and were in part soldiers, that is, they were not the people most likely to have acute forms of the disease,” notes Peter Openshaw. The results are therefore non-existent at this stage to assess how the most vulnerable individuals will react to this vaccine. Lack of information all the more worrying when Moscow announced at the end of August that Sputnik V would be administered primarily, from October or November, to the elderly, The Lancet emphasizes, in a leader.
Taken together, ”these results are encouraging and sufficient to conduct a Phase III study, ie on a larger population. But it would be unwise at this stage to carry out vaccinations outside a clinical protocol, warns Peter Openshaw.
Risk of playing the anti-vaccine game
Researchers from the Gamaleya Research Center in Moscow have also stated that they have started recruiting 40,000 volunteers to confirm the effectiveness of Sputnik V. test, says Éleanor Riley, an immunologist at the University of Edinburgh.
Moscow may be even more tempted to ignore this Phase III trial because US President Donald Trump has stated that he is also considering avoiding certain drug validation procedures. to speed up the marketing of a vaccine.
But this competition, which is the first, significantly increases the risk of problems in the development of the cure. – Precipitation can, among other things, lead to production errors, unintentional contamination of samples, says Peter Openshaw.
In the current health context, this risk-taking is a luxury that the world cannot afford, say researchers. “The public must have confidence in vaccine research. If we are not completely transparent and meticulous, we are simply playing the game with the anti-vaccine lobby, ”warns Michael Head, a public health policy expert at the University of Southampton, interviewed by the British Science Media Center. In other words, wanting to be the first at any cost can cost lives in this case.