An employee at work at the GF Gamelia Scientific Research Institute of Epidemiology and Microbiology of the Russian Ministry of Healthcare that produces the Covid-19 vaccine.
Vyacheslav Prokofayev | TASS | Getty Images
LONDON – A group of scientists has questioned the reliability of data published by Russian pathologists on the initial clinical trials of its “Sputnik V” coronavirus vaccine, with one telling CNBC that Russia needs to explain and clarify its findings.
Russia’s Gamalea Research Institute Epidemiology and Microbiology released test results of an early phase of its coronavirus vaccine on Friday, citing a group of scientists who said the data was incomplete.
They said the results showed that groups of participants reported similar antibody levels on different topics in the study. The letter has 27 signatures so far – mainly from Europe-based scientists. And including some from Asia.
“There are a lot of data patterns that appear frequently for the reported experiments,” the open letter said. “Based on a simple probability assessment, the fact of observing many of the data points saved between different experiments is highly unlikely.”
Scientists were also concerned about the lack of original statistics presented in The Lancet, saying “certainly no conclusions can be drawn on the reliability of the data presented, especially the obvious duplications found.”
U.S. “Although potentially very interesting, the research described in the article published by the Lancet presents many different points of concern,” Enrico Buchi, a professor at Temple University in Ma, said in a separate blog post. Buncey also had the signatures of the original author and the open letter to the editor of The Lancet.
Explaining to CNBC on Thursday the concerns of his and his colleagues’ signatures, Bookie said, “As a group of scientists, we feel the published data is incomplete.”
“At the moment, I need a disclosure and we need clarification, a list of signatures and will ask for clarification … the issue here (it’s there) is missing data, and strange data patterns. We came to a conclusion about this vaccine. Without having full access to data. “
CNBC on Thursday. The Gamaleya Institute, contacted by, was not immediately available for comment. Earlier, however, he rejected criticism of his vaccine, with Dennis Logunov, the organization’s deputy director, issuing a statement saying “the published results are authentic and accurate and were examined by five reviewers in the Lancet,” the Reuters report said.
Rush to publish
Noting that it was uncommon not to present complete data from clinical trials, Bussie compared the publication of clinical trial results of the early stages of the Oxford University-AstraZeneca vaccine. In this case, he said, the authors of the study provided 128 pages of supplementary material to peers for review. “If you compare the two (studies) … you can see that something is missing in Russian studies.”
Buchi said the lack of complete data is “the result of a rush to publish important information,” adding that “there is an undue pressure on scientists and clinicians around the world to assign what they have been doing before. They are ready.”
Giving another example of ambiguous results, Bookie said that part of the study showed 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 or very similar values for CD4 and CD8 cells. These are completely unrelated cells, how can it be that you have nine people Who has exactly the same number of CD4 and CD8? “
Bucci said the Lancet has now asked the authors of the Russian study to respond to concerns raised by the signatures. CNBC contacted the Journal for further comment and is awaiting a response.
The Sputnik V vaccine was regulated by Moscow in August, so despite health officials’ concerns, the vaccine has not yet passed large-scale Phase III tests, or because it does not have one, the world’s first green light. Peer-review results. Russia has denied the allegations in a statement issued Friday stating “Similar, baseless allegations concerning Russia’s intelligence have been made more than once. In late August, Gamaleana Logunov said 40,000 participants would be involved in the further investigation of the vaccine.
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