A gaggle of researchers have expressed concern about repetitive patterns of data in a paper describing early-phase scientific trials of Russia’s coronavirus vaccine — the primary jab worldwide to be authorized for widespread use.
In an open letter to the examine authors, who revealed the trial results1 this month in The Lancet, the researchers highlight values that appear to be duplicated, and warn that the paper presents its results solely as field plots with out offering an in depth breakdown of the data on which they’re primarily based. “While the research described in this study is potentially significant, the presentation of the data raises several concerns which require access to the original data to fully investigate”, the letter says. It has thus far been signed by 38 scientists.
The trials examined two barely totally different viral-vector vaccines — which use genetically engineered adenoviruses to supply coronavirus proteins in the physique — on 76 volunteers. The results indicated that the vaccine produced a robust immune response, and that unwanted side effects had been restricted to gentle, short-term results, comparable to irritation at injection websites or complications, in a number of individuals. In August, the Russian authorities authorized the vaccine, known as Sputnik V, for widespread use, and have stated that it might be out there to most of the people inside months.
This fast-track approval precipitated consternation among researchers, who argued that the choice to roll out the vaccine earlier than bigger security and efficacy trials had been accomplished was dangerously rushed.
The open letter was posted on a weblog run by molecular biologist Enrico Bucci, who heads a science-integrity firm known as Resis in Samone, Italy. Bucci says that he observed irregularities in the Lancet paper quickly after it was revealed. For instance, in one determine in which the authors report their measurements of markers of a sort of immune cell in the blood, many members of two teams of 9 volunteers examined with totally different formulations of the vaccine appear to have the identical ranges. “The odds of this arising by coincidence are extremely small,” Bucci says.
“To see such similar data patterns between unrelated measurements is really not likely,” says Konstantin Andreev, who research viral respiratory infections at Northwestern University at Evanston, Illinois. “These discrepancies are not minor.” Andreev had been independently involved about facets of the scientific trial, and signed the open letter shortly after it was made public.
“We are not alleging scientific misconduct, but asking for clarification about how these apparently similar data points came about,” says Bucci. “When we read reports that Russia had started to inject the vaccine into people outside clinical trials, we felt we had to speak out immediately.” Late-phase scientific trials of the vaccine, which can contain tens of 1000’s of individuals, started on 26 August.
The paper’s underlying data needs to be made out there, says epidemiologist Michael Favorov, president of DiaPrep Systems, a diagnostics firm in Atlanta, Georgia. “We have a lot of questionable data — in terms of its presentation,” he says. “Maybe the data are good — we can’t judge.” He provides that the choice to publish the stories with out the underlying data appears uncommon. By distinction, when scientific research involving a coronavirus vaccine that was developed by the pharmaceutical firm AstraZeneca and the University of Oxford, UK, had been revealed in the identical journal2, they had been accompanied by a considerable amount of supplementary data that different researchers had been capable of scrutinize.
The Russian paper’s lead writer, Denis Logunov on the Gamaleya National Research Centre for Epidemiology and Microbiology in Moscow, didn’t reply to requests for remark from Nature’s information group. But he advised the Russian information outlet Meduza that he didn’t intend to reply to the open letter. He denied that there have been errors in the publication, and said that measured antibody ranges had been “exactly as they were presented” in the figures. He added that he was in contact with the Lancet and “was ready to clarify any issues”.
The Lancet declined to touch upon its coverage for offering data in help of scientific trials that it publishes, however issued an announcement saying that it “has invited the authors of the Russian vaccine study to respond to the questions raised in the open letter by Enrico Bucci”, and that it could proceed to observe the state of affairs carefully.