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CORONAVIRUS – Sputnik V already in orbit? Vladimir Putin’s announcement of the launch of the first vaccine against the SARS-CoV-2 virus surprised the scientific community, as well as the public and foreign ministries around the world. Berlin, for example, questioned “its quality, efficiency and safety.” The name of the first artificial satellite, launched by the USSR in 1957, the Gamaleya Institute vaccine has something, apparently, to make the Russian authorities proud, who had been betting on its success for months.
In the race for preventive treatment in which hundreds of laboratories appear, Russian scientists have thus won the day, beating the other 27 candidates who are already in the clinical trial stage … and especially the five vaccines that are already in phase 3 testing, the last step before going to market.
The disclosed process is a double injection with a viral vector: this technology, developed in the 2010s, uses live viruses to transport their DNA to the patient’s cells. Several prestigious laboratories, also in the race to eradicate Covid-19, have decided to bet on this method with proven efficacy: AstraZeneca in Great Britain, CanSino biological in China … or the Pasteur Institute in France. But there is a problem.
Phase 3 nonexistent for Sputnik V
If we look at the most recent list, dated August 10, compiled by the World Health Organization (WHO) of vaccines that are being tested around the world, we find five names of companies that launched the famous phase 3: clinical trials in thousands of people, the duration of which cannot be less than several months. These companies are AstraZeneca, Sinovac, Sinopharm, Moderna and Pfizer … the Gamaleya Institute is not one of them.
And for good reason: for Spoutnik V, phase 3 will not take place … or rather, it will take place at the same time as marketing. When approving the placing on the market of the vaccine, the Russian authorities estimated through the voice of President Vladimir Poutine himself that “the vaccine works very well, gives real immunity” and “has passed all the necessary controls.” As a result, it will be available to Russians and then to foreign countries that have already requested it, such as Saudi Arabia.
At the same time, however, the chairman of the Russian Direct Investment Fund (RDIF), which is heavily funding the research, Kirill Dmitriev, announced that phase 3 of the clinical trials began “this Wednesday,” when the distribution of the the vaccine will start …
The first recipients of the vaccine will therefore act as test subjects, as the president of the Gamaleya Institute, Alexander Ginsburg, explained to the Russian news agency RIA Novosti: the first wave of vaccination “will be equivalent to a clinical phase 3, since the people served will remain under our supervision ”. Today it is not known how many doses will be produced for this “phase 3” disguised as a commercial launch, nor what kind of control will be exercised over patients.
However, “phase 3 is essential,” worries Canadian infectious disease specialist Isaac Bogoch. It is used to estimate the efficacy of the vaccine, but also to “identify possible rare side effects.” In late July, when Pfizer announced Phase 3 of its clinical trials, 30,000 people were scheduled to enroll, spread over 120 sites. None of this in the Russian case, which mixes clinical trials and makes it available to the general public.
A vagueness that unleashed the (prudent) irritation of the WHO, in the face of what many consider a media “coup”. “The prequalification of any vaccine goes through rigorous procedures,” admitted Tarik Jasarevic, a spokesman for the organization, shortly after the Russian announcement. It is true that from the beginning, the Russian laboratory has not bothered to respect the usual rules.
The blur doesn’t stop there
When Gamaleya announced that his treatment was ready for the Phase 1 clinical trial in early June, authorities decided to push hard on the accelerator. Instead of recruiting candidates, a sometimes lengthy process, the Russian military was asked to provide guinea pigs. A stage performed in 40 patients, whose results have not been published, before immediately after a phase 2 with even more blurred contours.
As the site reported Bloomberg On July 20, we do not know the number or name of the people who tested Sputnik 2 during phase 2, but the media evokes a system where dozens of Russians “with contacts in high places” were able to benefit from preventive treatment. Vladimir Putin’s daughter who was inoculated with the virus, according to her father, could be one of them. The data on this express procedure is scarce, to the point that the famous WHO document that does not include Gamaleya in clinical phase 3 … does not include him in phase 2, but in phase 1!
Undoubtedly, the Russian vaccine has therefore been developed with methods that go beyond the box and the usual sanitary precautions. Beyond the question of the effectiveness of Sputnik V, this attitude poses an ethical problem for Isaac Bogoch: “I understand that we all wanted a vaccine as soon as possible. But we can’t take a shortcut. “
See also in The HuffPost: Why has a coronavirus vaccine never been found?