Milan, September 15
A gaggle of scientists despatched a proper letter to the Lancet on Monday outlining doubts concerning the accuracy of early information on Russia’s COVID-19 vaccine, one of many authors mentioned, including additional gas to a dispute surrounding the “Sputnik-V” shot.
Fifteen scientists from 5 international locations signed the letter presenting their issues to the worldwide medical journal, Enrico Bucci, biologist adjunct professor at Philadelphia’s Temple University, advised Reuters.
Reuters didn’t see the contents of the letter. The transfer nonetheless highlights rising concern amongst scientists concerning the security and efficacy of the Sputnik-V vaccine, which the federal government accredited to be used earlier than finishing full human trials.
The official letter got here days after a bigger group of scientists – together with the 15 – signed an open letter to the Lancet’s editor, revealed on Bucci’s private weblog, after the journal revealed the early-stage trial outcomes from Moscow’s Gamaleya Institute.
They mentioned they discovered patterns within the Phase I/II information, which was peer-reviewed within the journal, that appeared “highly unlikely”, with a number of contributors reporting an identical antibody ranges.
The Gamaleya Institute didn’t instantly reply to a request for remark concerning the formal letter despatched on Monday.
Last week the institute rejected the critique contained within the open letter, which was initially signed by 26 scientists however now has 38 signatories.
“The published results are authentic and accurate and were examined by five reviewers at The Lancet,” Denis Logunov, a deputy director on the institute, mentioned in a press release.
He mentioned his institute submitted the complete physique of uncooked information on the trial outcomes to The Lancet.
The Lancet mentioned it had invited the authors of the Russian vaccine examine to answer the questions raised within the open letter by Bucci.
“We continue to follow the situation closely,” it added.
Alexey Kuznetsov, Russian assistant well being minister, advised the Interfax information company on Sept. 10 that the Gamaleya Institute had already despatched detailed solutions to the Lancet’s editor.
‘RESULTS ARE PLAUSIBLE’
Bucci mentioned the weblog revealed final week had drawn extensive worldwide assist.
“We started with about a dozen of us and now we have reached three times the signatures, with colleagues from the United States, Switzerland, Australia, India, Russia, Great Britain, Japan, Germany, Canada,” Bucci mentioned.
He mentioned the formal letter to the Lancet was signed solely by 15 scientists with experience in virology, immunology, pharmaceutical growth, analysis integrity and statistical evaluation. Most have been Italian, however in addition they included scientists from Sweden, Britain, the United States and Japan, he added.
“The journal’s editor wrote asking us to send him our points of objections and inviting the authors of Russian vaccine’s study to respond to our points,” mentioned Bucci.
Naor Bar-Zeev, deputy director at John Hopkins Bloomberg School of Public Health, who peer-reviewed the Russian information, final week defended his evaluation of the analysis following the publication of the weblog.
“The results are plausible, and not very different to those seen with other AdV vectored products,” he mentioned.
The researchers had offered extra element than was wanted for the overview and responded to his questions “intelligently and in a matter-of-fact and confident but understated manner”.
The outcomes of the Russian Phase I/II trials, which concerned 76 contributors and was carried out in June-July, have been revealed within the Lancet on Sept. 4. They confirmed that contributors developed a optimistic immune response and no critical unintended effects, the examine’s authors mentioned.
A Phase III trial, involving 40,000 contributors, was launched on Aug. 26. Around 31,000 folks have already subscribed to participate, Health Minister Mikhail Murashko mentioned.