The fuss around Sputnik
Scientists have published a letter expressing concern about the results of tests of the Sputnik-V vaccine
Maria Krivochenko, Naked Science
An international group of researchers has suggested that the reports on the trials of the Russian vaccine Sputnik-V may be inaccurate. Scientists were worried that there are repetitions in some graphs, and there is not enough data to check the results.
The open letter has already been signed by experts from Germany, Italy, the USA, Thailand, Switzerland and Japan. It was addressed to the authors of the Russian study on the trials of the Sputnik-V vaccine and the editor of the journal The Lancet to Richard Horton. In it, scientists analyzed the graphs published in the article and found similar fragments.
For example, in Figure number two, which shows the titer of IgG antibodies and neutralizing antibodies at different points in time for all groups of patients, they found duplicate data points. Nine of the volunteers who received rAd26-S (highlighted in red) apparently had the same antibody titers on day 21 and 28, as did seven of the nine volunteers who received rAd5-S (highlighted in yellow). In addition, experts have noticed that in the blue and green areas, the data converge in completely unrelated experiments. "It seems to us that the observation of such a number of coincidences in different tests is unlikely," the authors of the letter said.
Analysis of the second graph / © Enrico Bucci.
In the third figure, showing the results of the cellular response to various compounds that were tested on volunteers, experts also found similar data. However, in this case, the variable under study (the level of cell proliferation) is constant, so the probability of such coincidences is even lower. In the fourth graph, which shows the formation of neutralizing antibodies to the viral vectors used in the vaccine, they revealed the same problems as in the second.
Analysis of the third graph / © Enrico Bucci.
Frequent coincidences seemed suspicious to scientists and made them doubt the reliability of the study. In addition, the authors of the letter were concerned that their Russian colleagues did not provide the initial numerical data with which to check the accuracy of the graphs (especially in repeating segments). They noted that Russian researchers published insufficient information about recovered patients who acted as a control group, and did not compare it with the results obtained from different groups of volunteers. It would also be important for specialists to see data on each subject and find out when the plasma of volunteers was collected, how many days have passed since the first symptoms appeared and negative results of tests for coronavirus were obtained.
Analysis of the fourth graph / © Enrico Bucci.
The article by Russian scientists was published in The Lancet magazine in early September. It presents the results of the first and second phases of trials of the Sputnik-V vaccine. The authors of the study stated that the drug helped develop immunity to Covid-19 in all healthy study participants and did not cause serious side effects.
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PS to translate the letter to the editorial office of the Lancet:
In response to a request for comment, the editorial board of the journal The Lancet has sent the following statement:
"We encourage scientific debate around the published works and are aware of the open letter concerning the clinical trials of the Russian vaccine conducted by Logunov and his colleagues. We forwarded the letter to the authors and invited them to take part in the scientific discussion."
A representative of the Russian Direct Investment Fund delivered the following statement on behalf of the author of the article Denis Logunov:
"NITSEM named after Gamalei categorically rejects accusations of unreliability of statistical data published in The Lancet magazine.
The published data are reliable and accurate and have been examined by five reviewers The Lancet, a full-size clinical protocol was provided to the editorial board of the journal.
We presented exactly the data that we received, and not the ones that Italian experts should like."
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