The Drugs Controller General (DGCI) from the Indian Central Drugs Standard Control Organization announced on Thursday regarding Russia’s potential Covid-19 vaccine candidate Sputnik V to be clinically tested on 100 Indian volunteers.
The DGCI has given the necessary permit to Dr Reddy’s Laboratories for commencing the tests. Though, Dr Reddy’s Laboratories is yet to give any confirmed time frame for proceeding with the trials.
Sputnik stated the vaccine will be tried in the second phase of its clinical trials prior to direct testing for stage 3.
As per the data given by a government official, Dr. Reddy’s confirmed regarding the phase 2 trials, “Would include 100 subjects and for phase 3, it would take 1400 subjects.”
The official further added, “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.”
According to ANI, Dr. Reddy’s Laboratories made a re-application in a fresh protocol to the DGCI on October 13 asking approval for conducting the phase-2 and phase 3 clinical trials on Russia’s Sputnik V Covid-19 vaccine. It was on October 5 that Dr Reddy’s was asked by the Subject Expert Committee (SEC) to apply witn the revised protocols.
The Indian pharmaceutical giant has collaborated with Russian Direct Investment Fund (RDIF) for initiating the clinical trials of Sputnik V alongside the distribution. The RDIF will be supplying 100 million doses of the vaccine candidate to Dr Reddy’s Laboratories.
Sputnik V, the potential Covid-19 vaccine candidate, developed by RDIF and Gamaleya National Research Center of Epidemiology and Microbiology, approved by Ministry of health of Russia was the first vaccine to be registered in the world on August 11.
