Data on Russia’s Covid-19 vaccine trial results ‘questionable’, say international researchers

  • Concerns by scientists have been raised in an open letter to Russia's Covid-19 vaccine study authors
  • The scientists are requesting further clarity on published results
  • The lead author of the study, however, denies any errors in the report

Russia registered the world's first Covid-19 vaccine in August, with President Vladimir Putin claiming that it is effective, forms a stable immunity and has gone through all necessary tests. 

Later that month, a registration certificate for the vaccine, named Sputnik V, stated that it can only be used in certain small groups of people as large clinical trials had not yet begun (late-phase clinical trials only began on 26 August).

Scientists across the globe voiced their concerns about the safety and efficacy of the vaccine as very few details about the research had been made public. 

A preliminary report of the early-phase clinical trials has since been published in the journal, The Lancet, but in a recent open letter, signed by 38 scientists across more than 10 countries, a request has been made for access to the underlying data as, according to the scientists, the report lacks detailed information, and also includes results that appear to be duplicated.

The open letter was posted on a blog run by Enrico Bucci, a  molecular biologist who heads the science-integrity company, Resis, in Samone, Italy.

Presentation of data concerning

“During the current pandemic, the extreme public interest and expectations for an effective vaccine are understandable,” the letter reads, with the scientist adding:

“However, the very same reasons should motivate the scientific community to pay even more attention to the scientific evidence and the underlying data, and it is thus of utmost importance that they are fully available for close scrutiny.”

The key areas of concern highlighted in the letter are that values in the report seem to be duplicated, and that there is a lack of a detailed breakdown of the data on which they are 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,” it reads.

The results of the Covid-19 vaccine clinical trial developed by AstraZeneca and the University of Oxford, for example, were also published in the Lancet, and included, by contrast, a large amount of supplementary data that researchers were able to closely examine.

Not alleging scientific misconduct, but requesting clarification

Bucci said he noticed irregularities in the report soon after it was published. In one figure, for instance, he explains that the authors report their measurements of markers of a type of immune cell in the blood. According to the results, many participants of two groups of nine volunteers – tested with different formulations of the vaccine – seem to have had the same levels.

“The odds of this arising by coincidence are extremely small,” Bucci wrote.

Konstantin Andreev, who studies viral respiratory infections at Northwestern University at Evanston, Illinois, and who also signed the open letter, told Nature that “to see such similar data patterns between unrelated measurements is really not likely”, and that “these discrepancies are not minor”.

Bucci also explained to Nature that the scientists who signed the letter are not alleging scientific misconduct, but are simply asking for clarification about how the similar data points came about.

“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,” Bucci said.

Lead author denies errors in report

Lead author of Russia’s vaccine trial Denis Logunov at the Gamaleya National Research Centre for Epidemiology and Microbiology in Moscow, and lead author of the Russian paper, told the Russian news outlet Meduza that he did not intend to respond to the open letter.

According to Nature, Logunov also denied any errors in the publication, and said that measured antibody levels were “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 said it encourages debate on published papers and that the publication would continue to follow the situation closely.

READ | Russia’s Sputnik V Covid-19 vaccine only approved for use in small groups

READ | SA regulatory authorities won’t license Russian vaccine without access to evidence - Prof Gray

READ | OPINION | Scientists are working to fast-forward Covid-19 research, but not at the expense of ethics

Image: Getty/Paul Biris

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