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A group of scientists from leading Russian universities has blasted the development process of Russia\u2019s Sputnik V coronavirus vaccine as \u201ccompletely unacceptable\u201d and \u201cridiculous\u201d in an <\/span>open letter<\/span><\/a> raising new concerns over a lack of sufficient data on its safety and effectiveness.<\/span><\/p>\n The experts said Russia\u2019s state-run Gamaleya Research Institute, which is developing the jab, has ignored requests to share data \u2014 despite public pledges to do so \u2014 and have raised fresh fears over political meddling and a string of alleged shortcomings in the vaccine research.<\/span><\/p>\n<\/p><\/div>\n Concerns were <\/span>first raised<\/span><\/a> over Russia\u2019s Phase 2 trials \u2014 a limited program which involved just 76 volunteers \u2014 in the summer, after its results were published in The Lancet. But as Russia moved to Phase 3 trials and launched mass vaccinations, worries over poor standards of scientific research have compounded.<\/span><\/p>\n The group heavily criticized Russia\u2019s decision to <\/span>start<\/span><\/a> a mass vaccination program \u2014 which is officially only open to healthcare workers and teachers under the age of 60 with no underlying health conditions \u2014 while large-scale medical trials were still at such an early stage. Russia first published data on the vaccine\u2019s efficacy after it had recorded just 20 cases of Covid-19 among volunteers \u2014 a threshold that a number of international regulators deem far too small. Pfizer, Moderna and AstraZeneca, for instance, had to hit at least 90 cases before they could publish interim results.<\/span><\/p>\n \u201cThis completely unacceptable \u2014 even ridiculous \u2014 political action to create a competition between vaccines is in violation of the most important testing standards,\u201d wrote the scientists \u2014 led by Vasiliy Vlassov, an esteemed <\/span>epidemiologist<\/span><\/a> at Moscow\u2019s Higher School of Economics, former adviser to the Russian Health Ministry and World Health Organization (WHO) and vice chairman of a Russian Academy of Science commission against the falsification of research.<\/span><\/p>\n The race-like atmosphere made the vaccine developers \u201chostage\u201d to Russia\u2019s political goals, they said. \u201cIt threatens the benign testing of the vaccine and, therefore, poses a threat to the health of Russians.\u201d<\/span><\/p>\n<\/p><\/div>\n The letter was written by Vlassov along with Olga Rebrova, a professor at the Russian National Research Medical University, and Valery Aksyonov, scientific editor of Bionica Media. It was first published in November, and first <\/span>reported<\/span><\/a> Thursday by BBC Russia after having been sent to The Lancet in October.<\/span><\/p>\n Russia launched its mass vaccination program last weekend. In addition to volunteers in medical trials, tens of thousands of the country\u2019s political elite and healthcare workers had already been given the vaccine before it became widely available.\u00a0<\/span><\/p>\n Doctors told The Moscow Times this week they are <\/span>highly skeptical<\/span><\/a> about having the jab.<\/span><\/p>\n Only limited data on the <\/span>results<\/a> of the mass trials have been published, with 39 confirmed cases in the volunteer group and a claimed efficacy of around 92%. That is based on eight volunteers who were administered the vaccine catching Covid-19, and 31 in the placebo group.\u00a0<\/span><\/p>\n Russia has also not released details of the ages of participants in the trials or results broken down by demographic group. Vlassov believes this indicates that Russia prioritized vaccinating people under 60, as the vaccine could prove to be more effective on younger people and thus lead to more impressive results for the study.<\/span><\/p>\n In another difference with the Western vaccine trials, Russia split its volunteers into different-sized groups: 14,095 received the vaccine and 4,699 got the placebo \u2014 a three-to-one ratio. In its <\/span>guidance<\/span><\/a> on vaccine trials, U.S. regulators caution against conducting large-scale trials on anything other than a one-to-one ratio, as reducing the pool of volunteers receiving the placebo can skew results and could make it harder to catch enough different demographic groups across ages, health conditions and ethnicities to make statistically meaningful comparisons.<\/span><\/p>\n \u201c31 of 4,699 in the placebo group is a fairly small number in absolute terms and could easily change. The ratio of eight to 31 does not look statistically significant,\u201d said Konstantin Andreev, a medical researcher at U.S.-based Northwestern University who signed a different open letter criticizing the research.<\/span><\/p>\n Adding more confusion to the results of Russia\u2019s Phase 3 trials, deputy Moscow Mayor Anastasia Rakova <\/span>told reporters<\/span><\/a> last Friday that 273 volunteers had been infected with Covid-19, hailing the fact that meant only 1.5% had caught the disease. That number is misleading, Vlassov said, since efficacy is calculated based on a comparison of infection rates among a vaccinated group with a non-vaccinated group, not the overall infection rate. Moreover, Sputnik V developers are set to publish the next batch of interim results when there are 78 confirmed infections among the volunteers, and have not yet done so.<\/span><\/p>\n The Russian scientists also <\/span>called<\/span><\/a> on leading medical journal The Lancet, which published Russia\u2019s only peer-reviewed study on the vaccine\u2019s early trials, to retract the article which has drawn criticism from scientists around the world.<\/span><\/p>\n That article summarized research on the vaccine\u2019s safety and whether it triggered an antibody response among a very small cohort of 76 volunteers. Similar early-stage studies by the other vaccine candidates used significantly larger pools \u2014 up to 600 in the case of Moderna, the BBC reported.<\/span><\/p>\n \u201cWe believe that poor methodology, study design flaws, errors in data analysis, and a poor description of the study call into question the main conclusions about the safety and efficacy of the vaccine,\u201d Vlassov and his colleagues, members of the Russian Society of Specialists in Evidence Based Medicine, wrote.<\/span><\/p>\nTrial differences<\/h3>\n
Retraction<\/h3>\n