Bengal to lose chance to conduct Phase II trial of Sputnik V due to delay in govt's approval

West Bengal will likely lose the chance to conduct Phase II clinical trial of Russian Covid-19 vaccine candidate Sputnik V because of the delay in grant of approval by the state government, a top official of an organisation involved in facilitating the exercise said on Sunday.

The trails were proposed to start at the state-run College of Medicine and Sagore Dutta Hospital (CMSDH) in the North 24 Parganas district adjoining Kolkata later this week along with six other centres in different parts of the country.

"We are on the verge of losing 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," the head of business development at site management organisation CliniMed LifeSciences, Snehendu Koner, told PTI.

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He said that 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 internal matter of our department. However, I believe that several official holidays on account of festivals could have delayed the approval process. I cannot talk much 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 health department are not required to conduct trials for any vaccines or drugs. But surprisingly, we were asked to seek approval this time which delayed the process and eventually we are losing it," he said.

Clinical trials of Sputnik V will be conducted by pharma major Dr Reddy's Laboratories in coordination with the Russian Direct Investment Fund (RDIF).

The RDIF will be supplying 100 million doses of its potential Covid-19 vaccine to Dr Reddy's Lab.

During the Phase II trials, 100 volunteers will be chosen from all over the country. Out of the 75 will be administered the vaccine, while the rest will be given placebo -- a substance or treatment which is designed to have no therapeutic value.

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Koner said Phase III of the trial of the vaccine candidate will begin in India in January and the state health department and the CMSDH will be urged to expedite the approval process.

The site management organisation facilitates clinical trials by national and global pharmaceutical companies engaged in drug and vaccine development.

Citing interim trial results, Russia's health ministry claimed earlier this month that the Sputnik V vaccine had shown 92 per cent efficacy in preventing Covid-19.

The announcement had followed results unveiled earlier by vaccine developers Pfizer and BioNTech, who said their vaccine was more than 90 per cent effective at preventing the coronavirus disease.

The calculation was based on 20 confirmed Covid-19 cases split between vaccinated individuals and those who received the placebo, the RDIF had said.