The first batch of Russia’s Covid-19 Sputnik V vaccine is likely to reach Ganesh Shankar Vidyarthi Medical College in Kanpur by next week, following which its phase 2 and phase 3 human clinical trials will begin, PTI reported on Sunday.
RB Kamal, principal of Ganesh Shankar Vidyarthi Medical College, confirmed the clinical trials will start from next week. “As many as 180 volunteers have registered for the trials,” he said. “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.” The ethics committee of the college has also given its permission to conduct the trails, he added.
The condition and vitals of the volunteers will be monitored periodically, Kamal said, adding that the data will then be analysed to determine whether the vaccine is successful or not. The college principal also said Sputnik V’s effect on the volunteers will be evaluated for seven months after the vaccine is administered once, twice or thrice within an interval of 21 days.
After observing the vaccine’s effects for a month, authorities will be informed about the results of the trial and they can then make a decision accordingly.
The decision to conduct the trials was taken after pharmaceutical company Dr Reddy’s Laboratories received approval from the Drugs Controller General of India (DCGI) in this regard, an official said. The pharmaceutical company had partnered with Russian Direct Investment Fund, the country’s sovereign wealth fund, in September to conduct clinical trials of the Sputnik V vaccine and its distribution in India.
In October, Indian regulators had declined a proposal from Dr Reddy’s to conduct a large study on the Russian vaccine. An expert panel of the Central Drugs Standard Control Organisation said that there was not enough data available on the safety and immunogenicity of the vaccine from early-stage trials abroad, with no inputs on Indian participants.
On September 10, Russia had started inoculating volunteers with the Sputnik V vaccine against the coronavirus in Moscow. The country had rolled out the first batch of the vaccines for public use on September 8. The vaccine was found to produce an antibody response in all participants in early-stage trials, according to results published in the medical journal The Lancet.
More than 100 coronavirus vaccines are being developed around the world. India recorded 41,100 new coronavirus cases, taking the country’s total to 88,14,579, data from the health ministry showed on Sunday. The toll rose to 1,29,635 with 447 more deaths.
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