New Delhi: Researchers from the Gamaleya Research Institute of Epidemiology and Microbiology have said the approval of Covid-19 vaccine Sputnik V in 51 countries shows they have been fully transparent and comply with all regulatory requirements.
An international group of researchers had earlier questioned data discrepancies and lack of transparency around the interim results from Phase 3 clinical trials of the Russian vaccine.
The exchange happened through a couple of correspondences published in The Lancet journal on 12 May.
In the first correspondence, a team of researchers led by Enrico M. Bucci from Temple University in the US pointed out that several experts had found problematic data in the published phase 1/2 results of the vaccine trials.
“We have made multiple independent requests for access to the raw dataset, but these were never answered. Despite publicly denying some problems, formal corrections were made to the article, thus addressing some concerns,” it read.
“Notwithstanding the previous issues and lack of transparency, the interim results from the phase 3 trial of the Sputnik V vaccine again raise serious concerns,” the correspondence said.
The team, which included Gowri Gopalakrishna from Amsterdam University and Raffaele A. Calogero from the University of Turin, said they were concerned about the data, from which the investigators drew their conclusions, being unavailable.
They said changes were made in the trial protocol after the start of the study, but these changes were not explained. They also noted that the way Covid-positive cases were defined for the study was also ambiguous, and that the number of amplification cycles when performing PCR test was not mentioned.
Testing participants for Covid is key to accurately calculating efficacy of a vaccine.
The researchers also pointed out several inconsistencies in the data presented in the study.
This is not the first time that Bucci has pointed out gaps in the data published by Russian researchers.
In September last year, the scientist had pointed out unexplained repetitive patterns in a number of graphs used to present the results of the Sputnik V Phase 1/2 clinical trials.
Back then too, the scientists had demanded that the data from the clinical trials be made public.
‘Data in clinical study reports considered sufficient’
In its response to the Lancet correspondence, researchers involved in the clinical trial of the Sputnik vaccine wrote a detailed note in the Lancet.
“Clear and transparent regulatory standards exist for provision of clinical trial data, including data reported in clinical study reports that are considered sufficient for regulatory review and approvals. The reporting of the interim analysis1 in the phase 3 Sputnik V clinical trial fully complies with those standards,” the Russian researchers wrote.
They added that Sputnik V has received registration in 51 countries, which confirms full transparency and compliance with regulatory requirements.
They noted that the complete protocol had been submitted to The Lancet at the time of review of their study. They add that Covid tests were conducted using systems registered in Russia, and that it was “strange to ask about the number of amplification cycles when performing PCR on a registered test system”.
The group also dismissed the concerns about data discrepancies as “typing errors”, which were formally corrected.
The Russian researchers also noted that the safety and immunogenicity of the Sputnik vaccine has been confirmed independently by researchers in Argentina, where the vaccination with Sputnik V has begun.
Sputnik V is likely to be available in India from next week, Dr V.K. Paul, Member-Health, Niti Aayog, said during a press briefing Thursday.
He said the first batch of the vaccine had arrived already and more will be arriving from Russia.
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