Summer 2020, we cut champagne in the Kremlin. Russia was the first country to conduct human clinical trials and announce a good vaccine against Govt-19. On August 11, when the Spatnik satellite overtook the Americans and re-launched the 1957 series, Vladimir Putin considered it to be as efficient and reliable as “Kalashnikov”. The surprise effect was total, but the announcement was undoubtedly advance. “They are only done when they are in the second phase of clinical trials, Tara Verma, a member of the think tank of the ECFR, a voluntary organization. Vladimir Putin did not say whether the vaccine was licensed, verified or approved. He said, ‘We have I was able to find it in the first place and make it in the future. “
At the Kamalena company where it was designed, the staff are also very confident. “I saw young people working there, Says Paul Paul Cain, director of research at Insermin, which led a French mission to Russia in November 2020. In the whole team, they said they had no cases because they were all vaccinated and in other groups, there were a few patients. They believed that their vaccine would protect them. “ In September 2020 February 2, 2021, Two articles published in the journal Science The Lancet Come strengthen their feeling. A second published study states that Sputnik V is almost 92% effective.
But then things get out of hand. The Russian administration, unfamiliar with European rules, must learn to overcome the problems of European bureaucracy. Without the approval of the European Medicines Agency – called EMA European Pharmaceuticals Company – No access to the European market. A liar poker game follows. The Russians claim to have submitted their file on January 19, while at EMA headquarters they are assured that they have received nothing. It can last for several weeks. “Russians need to know how EMA registration applications went, Continues Mary Paul Gianni. They had to have a legal representative in the Union Territory. This company just needs to place the request. They know nothing about the process. Conclusion: The file will not be available until February. ” From this delay a doubt will arise. “After many conspiratorial European protests the Europeans began to say they were against Sputnik, Remembers Tara Verma. These are the elements of language that we hear so much about in Europe today. “
The truth, however, is much more complicated. Doubts have been raised about the reliability of the data contacted by Kamalina The Lancet. The efficacy rate of the vaccine, for example, is very consistent regardless of age. “92%, 90%, 91% of us are over 60 years old or 18-30 years old, Notes Jean-Daniel Llevre, Head of the Infectious Diseases Department at Montor Hospital in Gretel and vaccinator for Hot Autorita de Sande. In general, we lose performance with age. So this is very unusual. “ Andre Clibert, a specialist in analyzing the statistics and clinical curves of Rouen University Hospital, is very definite. “Sometimes things happen 1 in 100 chances. But twice in a row it starts less., He explains to Radio France’s investigative unit. With other contradictions in the article, and in the first Sputnik paper in phase 1-2, if there are contradictions, it starts to do a lot. “ The physician is very skeptical from the detection of other discrepancies: in some groups, the number of patients is not the same at the beginning and at the end of the test.
The pattern of people over the age of 60 also raises questions. “The vaccine developers were asked to evaluate its effectiveness in high-risk populations, Underscores Odil Lane, director of the vaccination center at Cochin Hospital, so among the elderly. However, only over 10% of the Sputnik V test included 60. This is a problem if you want to expand the results. “ Faced with all these questions, The Lancet He replied to the scientists that he had no intention of verifying the data sent by the Russians. The publication declined to answer questions from Radio France’s investigative unit.
Ilya Yasni, a Russian vaccine evaluator who works at the Infio Ventures Foundation, believes that the protocol provided on the composition of the groups that tested the vaccine is inadequate: “It doesn’t say for sure whether people are sick or not. It provides space for data manipulation.” Tito for the criteria used to select the 20,000 volunteers who participated in the experiments. “If you remove the symptoms of loss of taste and odor that are recognized by all international organizations as symptoms of goiter, it seriously calls into question the validity of scientific research.”, Tara Verma, explains ECFR, a voluntary organization
These critical scientists are also surprised that there is no concept from what is called pharmacovigilance. Although 13% of Russians have already received the first dose of Spotnik V in mid-June, it is possible to know from vaccinated people whether this feedback in a real situation will cause vaccine side effects. “Through the Astrogenogen-Oxford Vaccine and the Johnson Vaccine, we know that they cause thrombosis cases per 100,000 people per row of the Astrozeneca vaccine, and one million per Johnson vaccine., Odile Launay mentions. But no information is available about the Sputnik V vaccine. “
In addition, there are questions about the reliability of Russian manufacturing plants. In Slovakia, unconfirmed locations were declared by the National Regulatory Authority. “The people who designed this vaccine are serious, Says Mika Rumiandsef, a former researcher in Russia for the WHO. I know them well. But they are not accustomed to production. Conditions of production and control are not as severe in Russia as in the West. “
All these questions do not mean that the Russian vaccine is ineffective, but no doubt, the European pharmaceutical company has decided to start anew. It reviewed the data and began its research on May 10 in Russian factories. During this time, the EU has gradually increased its productivity. “300 million units are now distributed in 27 member countries, Says Nathalie Colin Osterley, a member of the European Parliament’s Health Committee. One billion will be produced in European soil by mid-July. So there is no rush to use the Sputnik vaccine. “ So the health calendar seems to have joined the political agenda, with many European leaders never supporting the possibility of relying on their complex Russian neighbors in the wake of the New Cold War.
However, does this political context weigh on the European pharmaceutical company? Tara Verma does not think so: “There has been a lot of criticism that we are going to take longer to recognize Spotnik V than others. But this is not true. As for the Pfizer and Moderna vaccines, we took several weeks. For the Astrogenega vaccine, it’s four months. So, we have an average. It takes a very long process. : Factory verification, medical equipment verification and, above all, double testing of vaccinated patients. The data provided by the manufacturer is valid. “
The decision of the European Pharmaceutical Organization is pending, and Russia continues to use its vaccine as a tool of influence. “Sputnik V is a tool of geopolitics, Believes former WHO inspector Micah Rumiandsef. France, Great Britain and the United States produce vaccines for their populations and the surplus is distributed to poor countries. Russia has a completely different approach. She exports “. In fact, it produces the least in its region, while it has already sold $ 1.5 billion overseas, adjusting its prices according to the financial capacity of each state. Today more than 70 countries use the Sputnik V, including Argentina, Serbia, Kazakhstan, Kyrgyzstan, Libya, Venezuela, but also the heavyweights of India and China. Meanwhile, perhaps, Europe …