Sputnik V Phase-3 trial likely to begin at Sagore Dutta Hospital mid-Jan

Sources in CMSDH said a technical advisory committee had already approved the third phase of the trial.

The third phase of the clinical trial of Russian Covid vaccine candidate Sputnik V is likely to begin at the state-run College of Medicine and Sagore Dutta Hospital (CMSDH) in the second week of January. The facility in Kamarhati in North 24 Parganas district is the second hospital after Peerless Hospital in Kolkata where the Russian vaccine candidate trial will be conducted.

Sources in CMSDH said a technical advisory committee had already approved the third phase of the trial. “Once the ethics committee gives a green signal, the trial will start. The next meeting of the ethics committee is on January 9,” a senior doctor told The Indian Express on the condition of anonymity.

Sources said the trial would begin a week after that as the probability of further hindrances was low. The site management organisation handling the logistics conducted necessary surveys to check the hospital’s infrastructure and cold-storage facilities before approaching the state health department for approval to conduct the trial. West Bengal had earlier lost the chance to conduct the Phase-2 trials after the government delayed the approval process.

The trial at the CMSDH will be part of pan-India Phase-3 clinical trial being conducted by Indian pharma company Dr Reddy’s, which has joined hands with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials. If found to be effective, the pharma company will also be in charge of the vaccine’s distribution. The RDIF has agreed to supply 100 million doses of the potential vaccine.

According to the amended protocol of the Drug Controller General of India, 100 volunteers will participate in the Phase-3 trials across India. Of them, 75 will get the vaccine and 25 will get the placebo. At the CMSDH, about 12 healthy volunteers are expected to be taken in for the trial.

Meanwhile, the SSKM Hospital in Kolkata has registered names of 10,000 of its employees, including doctors and Group-D staff, for the vaccination programme once it begins. According to sources, the authorities have already forwarded 8,000 names to the health department. Sources said 2,000 more names would be added to the list.

“Eight thousand names have been given already, 2,000 names are still pending. The list includes doctors, medical students, nurses, nursing students, our technical staff, Group-D staff et al. Once the vaccine arrives, doses will be given as per the list,” said SSKM Medical Superintendent-cum-Vice Principal (MSVP) Prof (Dr) Raghunath Misra.

Sources said the hospital was planning to inoculate 500 people a day, and finish the process in 20 days.

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