The trial of the Russian-made Covid-19 vaccine Sputnik V may soon begin at a hospital in Kolkata once the Drugs Controller General of India (DCGI) gives its nod.
Health Department sources said that the phase II clinical trial of the vaccine may start within a month at the College of Medicine and Sagar Dutta Medical College in Kolkata provided that necessary approvals were given.
They further revealed that the survey for determining whether the hospital had the required infrastructure and cold storage facilities was conducted by a site management company called CliniMed Life Sciences. The sources said that the organisation had given a favourable report.
The organisation recently visited the hospital and examined its storage facilities and other infrastructure required for the phase II clinical trials of the vaccine.
“They (the organisation) are satisfied with the infrastructure and the fact is that the hospital has previous experience of conducting clinical trials,” said a Health Department official. He also said that about a dozen healthy volunteers would be involved in the clinical trials at the College of Medicine and Sagar Dutta Medical College.
The survey report had been sent to the DCGI for approval. After getting the DCGI's approval the ethics committee of the hospital will issue a clearance for the phase II clinical trials of Sputnik V to begin there.
The trial of Sputnik V in India would be conducted by Dr Reddy’s Laboratory which was collaborating with the Russian Direct Investment Fund.
As per DCGI protocols out of the 100 volunteers involved in the phase II clinical trial of Sputnik V, the vaccine would be administered to 75 while the remaining 25 would get the placebo.
The Sputnik V vaccine was registered by the Health Ministry of Russia on August 11, 2020, and in the process became the world’s first registered Covid-19 vaccine.
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