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Volunteers participating in the Russian COVID-19 “Sputnik V” vaccine study will no longer receive placebo injections. It also stopped recruiting new volunteers for the study.
The Russian Ministry of Health has stopped recruiting volunteers for clinical trials of the Sputnik V COVID-19 vaccine, even though studies on the drug’s efficacy have not been completed. On December 23, the director of the Gamaleya National Research Center, Alexander Gintsburg, announced this to RIA Novosti.
According to him, the country’s Ministry of Health made it possible to stop the recruitment of volunteers because “everything is proven there, and the pandemic is approaching, and a placebo is not good at all.” Gunzburg believes that everyone who received a placebo and not a vaccine in the study should be vaccinated.
According to him, many of those who received a placebo found out after having performed the corresponding tests and then vaccinated. As a result, it was decided to no longer administer the placebo to the volunteers who had not yet dropped out of the study, but only the vaccine itself.
According to the BBC Russian Service, more than 23,250 people received the vaccine as part of the Sputnik V study and 7,750 people received placebo. Now the placebo group is smaller, and if the proportions of study participants change, this may affect your results.
Svetlana Zavidova, director of the Association of Clinical Research Organizations, noted that eventually Russian scientists will receive “some numbers,” but the reliability of these results will suffer.
Ilya Yasny, head of the scientific expertise of the Inbio Ventures fund, in a comment to Meduza, highlighted thatThe Sputnik V vaccine clinical trial was initially poorly planned. Now, the chances that normal quality data will still be collected for research, in his opinion, are nil, since from the beginning the process was not carried out according to international standards, but according to the extremely outdated Russians.
Anton Gopka, general partner at biotech fund ATEM Capital, noted that if the study continues, but subjects are not injected with a placebo, scientists may not know the most important thing: the long-term safety risks.
The Sputnik V vaccine was registered on August 11. Russian President Vladimir Putin declared that it is effective, forms stable immunity and has passed all tests. According to him, one of his daughters received two vaccinations and is doing well. At the same time, the Russian president himself was not vaccinated; As head of state, he cannot volunteer in a vaccine trial, explained Dmitry Peskov, the Russian leader’s press secretary.
The Russian vaccine has come under heavy criticism as it was registered before the third phase of clinical trials. Phase 3 trials are critical to testing vaccine readiness for widespread distribution, writes National Geographic. Several Russian scientists have observed that the accelerated approach to vaccine registration is contrary to scientific and ethical standards for drug development.
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