The Russian Sputnik V vaccine opposed to Covid-19 will be tested in India with a hundred volunteers, Sputnik, the general drug controller of the Central India Drug Control Organization (DCGI) told Sputnik on Thursday.
DCGI has pharmaceutical giant Dr Reddy’s Laboratories to carry out the checks, however, the date and time of the control will be decided through the company.
Sputnik quoted the organization as saying that the vaccine would be tested at the time of its clinical trials before moving to 3.
Last week, DCGI’s expert committee made Dr. Reddy’s laboratories legal for Phase 2 clinical trials on the Russian candidate Covid-19 vaccine, Sputnik V, India.
According to a government official, Dr. Reddy’s Lab stated that in the Phase 2 clinical trial, he would “come with a hundred subjects and by Phase 3, 1,400 subjects. “
“Once the pharmaceutical company submits The Phase 2 immunogenicity and protection data, they will be analyzed through the specialized organization and then can continue with the Phase 3 trial,” the official added.
On 13 October, ANI reported that Dr. Reddy’s laboratories had reapplied a new protocol at DCGI to seek approval for 2 and 3 clinical trials of the Russian Covid-19 vaccine.
It should be noted that on 5 October, the Committee of Experts on The Matter (SEC) conducted a thorough evaluation of the previous application filed through Dr. Reddy’s laboratory, subsequently ordering the pharmaceutical corporation to submit the application with a revised protocol and more information.
The Indian drug manufacturer has partnered with the Russian Direct Investment Fund (DRIF) for clinical trials on the Sputnik V vaccine and its distribution. According to the DRIF, it will supply one hundred million doses of its possible Covid-19 vaccine to India. Dr. Reddy’s corporate laboratory.
Last month, Kirill Dmitriev, EXECUTIVE Director of RDIF, reported that Russia in close discussion with the Indian government and Indian drug brands regarding the production location of its Sputnik V vaccine in India.
In addition, a prestigious medical journal The Lancet shows the effects of phase I-II clinical trials of the Russian vaccine demonstrating its protection and efficacy.
On 11 August, the Sputnik V candidate vaccine evolved jointly through RDIF and the Gamaleya National Centre for Epidemiology and Microbiology Research registered through the Russian Ministry of Health and has become the world’s first registered vaccine opposed to Covid-19.
According to Russian researchers, Sputnik V is a human adenoviral vector vaccine that fights coronavirus disease.
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