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"Sputnik V" vaccine: The crucial studies only take place after approval
Photo: TATYANA MAKEYEVA / REUTERS
Researchers led by Denis Logunov from the state Gamaleya Institute in Moscow have rejected criticism of the first known study on the Russian corona vaccine "Sputnik V" from the specialist magazine "The Lancet".
Almost 40 experts around the well-known molecular biologist Enrico Bucci, who heads a company for scientific integrity called Resis in Italy, had previously pointed out noticeable duplications in the diagrams of the publication.
There is a suspicion that it was manipulated clumsily, for example with Photoshop (read more about this here).
"We would like to emphasize that all the data presented were obtained in experiments and double-checked," the Russian researchers now write in response to the allegations.
Bucci and colleagues are not reassured by this.
You continue to view the work critically.
Among other things, the researchers noticed that, according to the Russian vaccine study, several test subjects had exactly the same antibody level in their blood on alternating days.
The value of the T cells that fight the coronavirus was also identical.
The subjects received different forms of the vaccine.
Bucci and colleagues consider it very unlikely that the duplications occurred by chance.
Data is missing
Logunov and colleagues now argue that the conspicuous patterns arose by chance and were due to the small number of test subjects in the various groups in the study.
The researchers themselves listed this as a weakness of the work in a chapter of the study.
Bucci's researchers counter this: "The authors have neither presented evidence to support their claim that the repetitions are expected and plausible, nor have they offered access to the original data," wrote Bucci on Wednesday at the request of SPIEGEL.
"Without access to the detailed original data, the statements cannot be verified."
It is part of good scientific practice not only to summarize data in the main document of a publication, but also to make the raw data accessible in addition so that independent researchers can understand and check the calculations and the generation of statistics in detail.
The requirement for transparency applies in particular to clinical studies, for example on vaccines.
"Unacceptable in Science"
Logunov's team has not yet complied with this.
After the criticism, it only said that it would release the data upon request and after the request was approved.
Bucci describes the approach as "unacceptable in science".
"That should never have passed with 'The Lancet", "he writes. Upon request, the journal announced that according to the editorial guideline, authors only had to provide a declaration of data exchange. This was done.
At the beginning of August 2020, Russia provisionally approved "Sputnik V", the first corona vaccine worldwide, for widespread use.
Even then, there was criticism that the decisive phase III study on efficacy and safety had not yet been carried out and that hardly any data was known about the tests that had taken place up to that point.
After the first information from small, combined phase I and phase II investigations had finally been published in "The Lancet" at the beginning of September, allegations of counterfeiting arose.
Four days after the Russian study was published, Bucci and 36 other experts published a "Note of Concern", an open letter in which they pointed out the irregularities and requested that the raw data from the study be published.
"The Lancet" asked the authors of the study for their comments and has now published both the criticism of Bucci and colleagues and the response of the Russian researchers.
"We are following the situation closely," said the trade journal in mid-September at the request of SPIEGEL.
The study was reviewed by international experts for Covid-19.
"The Lancet" is one of the most renowned medical journals worldwide.
There is now another request to publish the data directly to the Russian researchers, said Bucci.
Whether they comply with the request is, however, at their own discretion.
"The process is incredible and shouldn't be allowed in such important research."
Bucci and his colleagues are still missing explanations as to why Logunov's Russian team changed the study procedure in the meantime and instead of the originally planned two phase I studies, two combination studies from phase I and II took place.
The Russian researchers admit that none of the clinical studies reported in their paper have been completed.
According to Bucci, this confirms the suspicion that the Russian vaccination study was published in a hurry.
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