The first human tests of Sputnik V, the Russian vaccine against Covid-19, have shown encouraging results. But the findings, published in The Lancet on Saturday, are still considered insufficient to justify Russian President Vladimir Putin’s decision to allow it to be used by the general public.
We can now put a little scientific seriousness in the debate around Sputnik V, the controversial Russian vaccine against Covid-19. Researchers from the Gamaleya National Research Center for Epidemiology and Microbiology in Moscow, responsible for its development, have finally released the first results of clinical trials conducted on humans in the scientific journal The Lancet, Saturday 5 September.
An article eagerly awaited since the shocking decision of the Russian president Vladimir Putin to give the green lighton August 11 for use of this vaccine on the general public. This announcement had caught 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 on the altar of the media and political coup: the Russian vaccine became, in fact, the first in the world, the use of which was officially authorized by a government.
“So far so good”
The article published in The Lancet supports, in part, the hopes that Moscow has placed in Sputnik V. “It establishes 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 by the virus ”, summarizes Peter Openshaw, immunologist at the Imperial College of London, contacted by France 24.
The reaction of the immune system described by Russian researchers is comparable, if not slightly stronger, than that induced by the vaccine developed at Oxford, considered one of the most promising, says the British scientist.
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. Scientists also concluded that there were no adverse effects. notables ”associated with this vaccine. “Until then, everything is fine,” confirms Brendan Wren, an infectious disease specialist at the London School of Hygiene & Tropical Medicine, quoted by the BBC.
Was Vladimir Putin therefore right to claim victory before everyone else, ensuring that “all the necessary tests had been successfully carried out”? That would be going very quickly, warns Peter Openshaw.
What about populations at risk?
First, some patients developed high fevers, above 39 ° C, after receiving the vaccine. “Sure, if it’s about fighting a potentially deadly virus, you can classify it as acceptable side effects, but that’s not trivial either,” says Peter Openshaw.
In addition, Sputnik V has only been tested on 76 volunteers. This is little to draw general conclusions about its effectiveness. “There weren’t 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 the Science Media Center website.
These volunteers were also “all under the age of 60 and were, in part, soldiers, that is to say they were not the people most likely to have acute forms of the disease”, Peter Openshaw notes. The results are, therefore, at this stage nonexistent to assess how the most at risk individuals will react to this vaccine. A lack of information all the more worrying as Moscow announced at the end of August that Sputnik V was going to be administered in the first place, from October or November, to the elderly, underlines The Lancet, in an editorial.
Overall, “these results are encouraging and sufficient to initiate a phase III trial, ie on a larger population. But it would be unwise at this stage to carry out vaccinations outside of a clinical protocol, ”warns Peter Openshaw.
Risk of playing the anti-vaccine game
Researchers from the Gamaleya research center in Moscow have, moreover, indicated that they had started recruiting 40,000 volunteers to confirm the effectiveness of Sputnik V. “The whole question is whether the political pressure exerted will that the vaccine will be distributed to the general public before the results of this large-scale test, ”says Éleanor Riley, immunologist at the University of Edinburgh.
Moscow may be all the more tempted to skip this Phase III trial as US President Donald Trump has indicated he, too, is considering saving some drug validation procedures to speed up the marketing of a vaccine.
But this race to be the first greatly increases the risk of problems in the development of the remedy. “Precipitation can lead to, among other things, errors in production, accidental contamination of samples,” says Peter Openshaw.
In the current health context, this risk-taking is a luxury that the world cannot afford, say scientists. “The public needs to have confidence in vaccine research. If you are not perfectly transparent and rigorous, you are simply playing the game of the anti-vaccine lobby, “warns Michael Head, public health policy expert at the University of Southampton, interviewed by the UK Science Media Center. In other words, wanting to be the first at all costs can, in this case, cost lives.