The developers of Russia’s Sputnik V vaccine against the novel coronavirus responded to criticism of their article about the vaccine’s clinical trials, published by The Lancet journal.
Their letter, sent to the journal’s editorial board, and arguments given by the group of scientists who criticized the article, were published on The Lancet’s website on Friday evening.
Denis Logunov, a deputy research director at the Gamaleya Center, and his co-authors promised to provide access to health records of certain volunteers, so that all the existing issues are clarified.
“We would like to emphasize that all presented data were obtained in experiments and double checked,” the letter reads.
“The coincidences that emerged, especially at the early points (values are low and areclose to baseline), are associated with the discreteness of the data, as well as with the small number of participants in the groups. We acknowledged this as a limitation of the study in the discussion section of the Article.”
“We confirm that individual participant data will be made available on request to DYL and that after approval of a proposal, data can be shared through a secure online platform,” the Russian scientists said.
On September 7, some scientists from US, Italian and other universities released an open letter to the Russian researchers, drawing their attention to some experiments depicted in the article, where, according to the letters’ authors, certain statistics anomalies could be detected.
The Russian scientists announced their readiness to provide required explanations to The Lancet, if the journal requests that.
Russian vaccine developers sent their explanations to The Lancet on September 10.
Last week, Alexander Kabanov, Associate Member of the Russian Academy of Sciences and Professor of North Carolina University and Moscow State University, told TASS that criticism of scientific articles is part of a normal scientific process, “moreover, when we talk about the works of paramount social importance, like a vaccine or a drug amid the pandemic.”
He emphasized that this criticism does not mean that the researchers’ results are erroneous.
Kabanov recalled that three months ago, articles by US scientists were withdrawn from two leading journals, including The Lancet, after criticism of the published results and the refusal to provide primary data on the outcome of their research on the use of certain drugs to treat COVID-19.
On August 11, Russia registered the world’s first vaccine against the novel coronavirus. The vaccine, dubbed Sputnik V, was developed by the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Health Ministry, and its clinical trials were successfully completed in June-July. The vaccine was developed on a platform that had been used for a number of other vaccines.