New Delhi: A total of 13 volunteers have been administered Russia’s Sputnik V vaccine against COVID-19 in Kanpur’s Ganesh Shankar Vidyarthi Medical College as part of phase-II human clinical trials. The decision to conduct the human clinical trials of the vaccine was taken after Dr Reddy’s Laboratories got approval from the Drugs Controller General of India (DCGI) in this regard, an official said.
Sputnik V vaccine has been developed by the Gamaleya National Research Center of Epidemiology and Microbiology and Russian Direct Investment Fund (RDIF). As per reports, India has purchased 100 million doses of the candidate from Russia.
Earlier last month, the college principal R B Kamal said the human clinical trials of the vaccine will start from next week. As many as 180 volunteers have registered for the trials. Head of the research Saurabh Agarwal will determine the dosage of the vaccine to be administered. One dose will be administered and the condition of volunteers will be monitored to determine whether they need further doses or not,” he said.
Kamal said the volunteers’ vitals and condition will be checked periodically and the data will be analysed to determine whether the vaccine is a success or not. He said the effect of the vaccine on the volunteers will be studied for seven months after the same is administered once, twice or thrice within an interval of 21 days.
According to the Clinical Trial Registry- India (CTRI), a total of 1,600 subjects are planned to be roped in for these trials (100 in phase-II and 1,500 in phase-III).
Besides Kanpur, 17 volunteers have also been administered the Sputnik V coronavirus vaccine at Pune’s Noble hospital as part of phase-II human clinical trials, doctors said.
Trials for this vaccine are also planned to be held in Lucknow(Uttar Pradesh), Jaipur (Rajasthan), Vellore (Tamil Nadu), Mysore (Karnataka) and Puducherry. Dr Reddy’s Laboratories Limited and Sputnik LLC are jointly conducting these trials.
(With Agency inputs)