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Scientists question data from Russian vaccine studies on “unlikely” models

An employee at work at the Gamaleya Scientific Research Institute of Epidemiology and Microbiology of the Russian Ministry of Health producing a COVID-19 vaccine.

Vyacheslav Prokofyev | TASS | Getty Images

LONDON – A group of scientists questioned the reliability of data published by Russian epidemiologists on early clinical trials of its ̵

6;Sputnik V’ coronavirus vaccine, with one telling CNBC that Russia needs to explain and clarify its results.

In an open letter to the editor of the medical journal The Lancet, in which Russia’s Gamaleya Research Institute of Epidemiology and Microbiology released on Friday the results of the early-stage trial of its coronavirus vaccine, a group of scientists said that the data were incomplete and had shown some “unlikely patterns”.

They said the results showed that the groups of participants had reported identical antibody levels at different points in the study. So far there are 27 signatories to the letter, mostly scientists based in Europe, but also several in the US and Asia.

“There are several data patterns that appear repeatedly for the reported experiments,” the open letter said. “Based on simple probabilistic assessments, it is highly unlikely to observe so many stored data points between different experiments.”

Scientists were also concerned about the lack of original numerical data presented in The Lancet, stating that “no firm conclusions can be drawn about the reliability of the data presented, especially regarding the apparent duplications found.”

“While potentially of great interest, the research described in the Lancet paper presents several points of concern,” Enrico Bucci, a professor at Temple University in the United States, said in a separate blog post. Bucci was also one of the original authors and signatories of the open letter to the editor of The Lancet.

Explaining his and his fellow signatories’ concerns, Bucci told CNBC Thursday that “as a group of scientists, we believe the published data is far from complete.”

“At this point, I need an explanation and we need clarification, the list of signatories needs and ask for clarification … The point here (is that there are) missing data and strange data patterns. We can’t get to a conclusion on this vaccine without having full access to the data. “

The Gamaleya Institute was not immediately available to comment when it was contacted by CNBC on Thursday. Previously, however, he dismissed criticism of his vaccine, with Denis Logunov, the institute’s deputy director, issuing a statement saying that “the published results are authentic and accurate and have been reviewed by five Lancet reviewers. “, Reuters reported.

Run to publish

Stating that it was unusual not to be presented with full clinical trial data, Bucci compared it with the Oxford-AstraZeneca University of Oxford-AstraZeneca early stage clinical trial results publication. In this case, he said, the study authors provided 128 pages of supplemental material for peer review. “If you compare the two (studies) … you can see that something is missing in the Russian study.”

Bucci said the lack of complete data is “the product of the rush to publish important things”, adding that “all over the world, there is undue pressure on scientists and doctors to give up what they are doing before. they are ready. “

Providing another example of unexplained results, Bucci said part of the study appears to show different immune cells producing identical responses in a group of individuals. “There are two different types of immune cells, CD4 and CD8, and nine out of nine are exactly or very similar values ​​for CD4 and CD8 cells. These are completely independent cells, how can it be that you have nine people who have exactly the same number. of CD4 and CD8? “

Bucci said The Lancet has now asked the authors of the Russian study to address concerns raised by the petitioners. CNBC has reached out to the magazine for further comment and is awaiting a response.

The “ Sputnik V ” vaccine gained regulatory approval from Moscow in August, making it the first in the world to receive the green light despite concerns among health officials that the vaccine has not yet undergone phase III studies. large scale, or that it had had its peer-reviewed results. Russia rejected criticism of its vaccine, saying it was safe and effective. In late August, Gamaleya’s Logunov said further testing of the vaccine would involve 40,000 participants.

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