West Bengal will lose the prospect to conduct Phase II medical trial of Russian COVID-19 vaccine candidate Sputnik V due to the delay in grant of approval by the state authorities, a prime official of an organisation concerned in facilitating the train stated on Sunday.
The trials have been proposed to start out on the state-run College of Medicine and Sagore Dutta Hospital (CMSDH) in North 24 Parganas district adjoining Kolkata later this week together with six different centres in several elements of the nation.
“We will not be able to hold the Phase II trials of Sputnik-V vaccine at the CMSDH because of the slow approach of the state health department in giving the approval. We had applied for the approval on November 4 and there is no response yet. It’s too late now.
“Even if the approval is given at this time, holding the trials won’t be possible,” the head of business development at the site management organisation CliniMed LifeSciences, Snehendu Koner, told PTI.
He said while the initial feasibility process at CMSDH started along with the other centres where the trials are to take place, the approval could not be obtained in time.
After securing the health department’s approval, the consent of the hospital’s Institutional Ethics Committee (IEC) is also required before starting the trials, Koner said.
The IECs of the rest six institutions have already given the go ahead for the trials.
When contacted, a senior official of the state health department, who was unwilling to be named, said, “This is an inside matter of our division. However, I imagine that a number of official holidays on account of festivals might have delayed the approval course of. I can not discuss a lot about it. We will look into it.”
The site management organisation had conducted necessary surveys to check infrastructure and cold storage facilities at the Sagore Dutta Hospital before approaching the state health department for approval to conduct the trials.
“Such approvals from the state well being division are usually not required to conduct trials for any vaccines or medicine. But surprisingly, we have been requested to hunt approval this time which delayed the method and ultimately we’re shedding it,” he stated.
Clinical trials of Sputnik V might be carried out by pharma main Dr Reddy’s Laboratories in coordination with Russian Direct Investment Fund (RDIF).
The RDIF might be supplying 100 million doses of its potential COVID-19 vaccine to Dr Reddy’s Lab.
Koner stated Phase III of the trial of the vaccine candidate will start in India in January and the state well being division and the CMSDH might be urged to expedite the approval course of.
The web site administration organisation facilitates medical trials by nationwide and international pharmaceutical firms engaged in drug and vaccine improvement.
Citing interim trial outcomes, Russia’s well being ministry claimed earlier this month that Sputnik V vaccine had proven 92 per cent efficacy in stopping COVID-19.
The announcement had adopted outcomes unveiled earlier by vaccine builders Pfizer and BioNTech, who stated their vaccine was greater than 90 per cent efficient at stopping the coronavirus illness.
The calculation was primarily based on 20 confirmed COVID-19 instances break up between vaccinated people and those that acquired the placebo, the RDIF had stated.
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