The Russian Sputnik V vaccine against COVID-19 will be tested in India on 100 volunteers, the Indian Central Drugs Standard Control Organisation’s Drug Controller General (DCGI) told Sputnik on Thursday. DCGI has granted permission to pharmaceutical giant Dr Reddy’s Laboratories for conducting tests. However, the date and time of the test will be determined by the company. Sputnik quoted the organisation as saying that the vaccine will be tested in the second phase of its clinical trials before moving on to phase 3.
Last week, the expert committee of DCGI had recommended granting permission to Dr Reddy’s Laboratories for conducting phase 2 clinical trials of Russian COVID-19 vaccine candidate, Sputnik V, in India. According to a government official, Dr Reddy’s Lab has stated that in phase 2 clinical trial–“would include 100 subjects and for phase 3, it would take 1400 subjects.”
“Once the pharma company would submit the safety and immunogenicity data of phase 2, it would be analysed by the expert panel and then they can proceed for the phase 3 trial,” the official added. On October 13, ANI had reported that Dr Reddy’s Laboratories re-applied fresh protocol to DCGI in order to seek its approval for conducting phase 2 and 3 clinical trials of the Russian COVID-19 vaccine.
It may be noted that on October 5, the Subject Expert Committee (SEC) had done a thorough evaluation of the previous application submitted by Dr Reddy’s lab. Thereafter, the SEC had directed the pharma company to apply with a revised protocol along with more information.
The Indian drugmaker has joined hands with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution. As per the RDIF, it will supply 100 million doses of its potential COVID-19 vaccine to India drug company Dr Reddy’s Lab.
Last month, Kirill Dmitriev, CEO, RDIF informed that Russia is in close dialogue with the Indian government and drug manufacturers of India regarding localisation of production of its Sputnik V vaccine in India. Also, a prestigious medical journal The Lancet had published the results of clinical trials of Phase I-II of the Russian vaccine demonstrating its safety and efficacy.
On August 11, the Sputnik V vaccine candidate developed jointly by RDIF and the Gamaleya National Research Center of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19.
According to Russian researchers, Sputnik V is a human adenoviral vector vaccine that fights against coronavirus disease.