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LONDON – A group of scientists has questioned the reliability of data published by Russian epidemiologists on early clinical trials of their “Sputnik V” coronavirus vaccine, with one telling CNBC that Russia should explain and clarify its results is required.
In an open letter to the editor of The Lancet Medical Journal, in which Russia’s Gamalaya Research Institute of Epidemiology and Microbiology published results of an early-stage test of its coronavirus vaccine last Friday, a group of scientists said the data were incomplete and Some had shown “unlikely patterns.”
They stated that the results showed that groups of participants reported similar antibody levels at different points in the study. So far the letter has 27 signatories – mainly scientists based in Europe but includes many from the US and Asia.
“There are several data patterns that appear repeatedly for reported experiments,” the open letter said. “The fact of observation of multiple data points preserved between different experiments based on simple probabilistic evaluation is not very likely.”
Scientists were also concerned with the lack of original numerical data presented in The Lancet, stating that “no conclusions can be drawn definitively on the reliability of the data presented, especially regarding the apparent duplication detected.” . ”
“With potentially great interest, the research described in the article published by Lancet presents several points of concern,” Professor Enrico Bucci of Temple University in the US said in a separate blog post. Bukki was also the original author and signatory of an open letter to the editor of The Lancet.
Explaining the concerns of himself and his fellow signatories, Bukki told CNBC on Thursday, “As a group of scientists, we think the data published are far from complete.”
“At this point, I need an explanation and we need an explanation, a list of signatories and ask for clarification … The point here (is that) is missing data, and weird data patterns. We Cannot reach a conclusion on this vaccine. Without full access to the data. ”
The Gemaleya Institute was not immediately available to comment when contacted by CNBC on Thursday. Earlier, however, it denied criticism of his vaccine with Denis Logunov, a deputy director of the institute, in which he issued a statement stating that “the published results are authentic and accurate and examined by five reviewers in The Lancet, “Reuters reported.
Rush to publish
On being told that it was unusual not to be presented with complete data from clinical trials, Bucci compared the publication of early-stage clinical trial results of the University of Oxford-AstraZeneca vaccine. In this case, he said, the study’s authors provided 128 pages of supplementary material for peers to review. “If you compare the two (studies) … you can see that something is missing in Russian studies.”
Bucci said that the lack of complete data was “the product of a rush to publish important things,” adding that “all over the world, there is undue pressure on scientists and practitioners to hand over what they have been doing before.” ” they are ready. ”
Giving another example of unexplained results, Bukki stated that part of the study displays different immune cells producing similar responses in a group of individuals. “There are two different types of immune cells, CD4 and CD8, and nine out of nine have exactly the same or very similar values for CD4 and CD8 cells. These are completely unrelated cells, how could that be? Is that you have nine people who actually are. The same number of CD4 and CD8? ”
Bukki said the Lancet had now asked the Russian study authors to respond to concerns raised by the signatories. CNBC contacted the magazine for further comment and is awaiting a response.
The ‘Sputnik V’ vaccine was granted regulatory approval by Moscow in August, making it the first green light in the world, despite concerns among health officials that the vaccine has not yet been covered by large-scale Phase III trials. Had undergone, or had had, the results reviewed by peers. Russia dismissed criticism of its vaccine, saying it was safe and effective. In late August, Gamalaya’s Logunov said 40,000 participants would be involved in another vaccine trial.