MOSCOW, DEC 11 – A group of researchers at prestigious Russian universities has criticized the development of the Russian anti-covid Sputnik V vaccine as “completely unacceptable” and “ridiculous.” The criticisms were made in an open letter which raises new concerns about the lack of sufficient data on the safety and efficacy of the vaccine.

Experts say Russia’s state-run Gamaleya Research Institute, which is rapidly developing the vaccine, has ignored requests to share data, despite public commitments to do so. They are talking about the mixture of political interests in the Sputnik V vaccine.

The first irregularities were reported in Phase 2 studies in Russia – a limited program, which involved only 76 volunteers – in the summer, after its results were published in The Lancet. But as Russia moves into phase 3 studies and launches mass vaccinations, concerns about poor scientific research standards have worsened.

The group of researchers strongly criticized Russia’s decision to start a mass vaccination program – which is currently available to health workers and teachers under the age of 60 – while large-scale medical studies were still under way. such an early stage.

Russia first published data on the effectiveness of the vaccine after registering only 20 cases of Covid-19 among volunteers, a threshold that a number of international regulators consider far too low. Pfizer, Moderna and AstraZeneca, for example, had to record at least 90 cases before they could publish the interim results.

“This completely unacceptable – even ridiculous – political action to create competition between vaccines violates the most important testing standards,” wrote the scientists, led by Vasiliy Vlassov, a renowned epidemiologist at the Moscow School of Economics. Adviser to the Russian Ministry of Health, WHO Representative.

This competitive atmosphere has made the developers of the Sputnik V vaccine “hostages” of Russia’s political goals, the researchers accuse. “It threatens benign vaccine testing and therefore poses a threat to Russian health.”

The open letter was signed by Vlassov together with Olga Rebrova, a professor at the National Medical Research University of Russia, and Valery Azioniov, scientific editor of Bionica Media.

Russia launched its mass vaccination program last weekend. In addition to medical volunteers, tens of thousands of political elites and health workers had received the vaccine before it became widely available.

Doctors told The Moscow Times this week that they were extremely skeptical about the vaccine.

To date, only minimal data on the results of mass studies have been published, with 39 confirmed cases in the volunteer group and a sustained efficacy of approximately 92%. But this effectiveness is based on only 8 volunteers who received the vaccine.

Russia also did not disclose details about the age of the study participants or the results broken down by demographic groups. Vlassov believes that this indicates that Russia has given priority to vaccinating people under 60, as the vaccine may prove to be more effective for younger people and therefore lead to better imaging results of the study.

Vlassov-led researchers have also called on the medical journal The Lancet, which published the only Russian peer-reviewed study on early vaccine studies, to withdraw the article, which has drawn criticism from scientists around the world.

This article summarized research on vaccine safety and whether it triggered an antibody response among a very small cohort of only 76 volunteers. Similar early-stage studies conducted by other candidates to develop an anti-covid vaccine used significantly larger pools – up to 600 in the case of Moderna.

“We believe that the poor methodology, the design flaws of the study and the errors in the data analysis call into question the main conclusions regarding the safety and efficacy of the vaccine , “ wrote Vlassov and colleagues.