By Polina Ivanova

MOSCOW (Reuters) – Twenty-six scientists, most of them working at universities in Italy, have signed an open letter questioning the reliability of the info introduced within the early-stage trial outcomes of the Russian COVID-19 vaccine, named “Sputnik-V”.

Addressing the editor of The Lancet, the worldwide peer-reviewed medical journal through which Moscow’s Gamaleya Institute revealed its early-stage trial outcomes, the scientists stated they noticed patterns within the knowledge that appeared “extremely unlikely”.

The letter, revealed on the non-public weblog web page of one of many signatories, stated the Section I/II trial outcomes knowledge confirmed a number of individuals reporting similar antibody ranges.

“On the bottom of straightforward probabilistic evaluations the very fact of observing so many knowledge factors preserved amongst totally different experiments is extremely unlikely,” the open letter stated.

Nevertheless, the scientists stated they had been basing their conclusions on summaries of the Russian trial end result knowledge, revealed within the journal, reasonably than the unique knowledge itself.

“In lack of the unique numerical knowledge, no conclusions could be definitively drawn on the reliability of the info introduced, particularly relating to the obvious duplications detected,” the letter stated.

The Gamaleya Institute, which developed the vaccine, rejected the critique.

“The revealed outcomes are genuine and correct and had been examined by 5 reviewers at The Lancet,” Denis Logunov, a deputy director on the institute, stated in a press release.

He stated his institute submitted your entire physique of uncooked knowledge on the trial outcomes to The Lancet.

“We introduced particularly the info that was produced (by the trial), not the info that’s speculated to please Italian consultants,” Logunov stated.

Naor Bar-Zeev, deputy director at John Hopkins Bloomberg Faculty of Public Well being, who peer reviewed the Russian knowledge, defended his evaluation of the analysis.

“Science should preserve a stability between incredulity, skepticism and belief. That belief is borne out by way of plausibility, repeatability and falsifiability.”

“The outcomes are believable, and never very totally different to these seen with different AdV vectored merchandise,” he stated.

The researchers had offered extra element than was wanted for the evaluate and responded to his questions “intelligently and in a matter-of-fact and assured however understated method”.

“Backside line, I noticed no motive to doubt the legitimacy of those outcomes over others I’ve learn and reviewed. However after all one can by no means know,” he stated in an electronic mail.

A spokeswoman for the Lancet stated the journal had invited the examine’s authors to reply to the questions raised within the open letter. It was following the state of affairs intently, she stated.

Russia revealed outcomes on Friday of its Section I/II trial, which included 76 individuals and was performed in June-July this yr. Contributors developed a constructive immune response and no severe unwanted side effects, the examine’s authors stated.

A Section III trial, involving 40,000 individuals, was launched on Aug. 26. Round 31,000 folks have already subscribed to participate, Well being Minister Mikhail Murashko stated.


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