Sputnik V to be clinically tested on 100 Indian volunteers
NEW DELHI [Maha Media]: The Russian COVID-19 vaccine Sputnik V will be tested in India on 100 volunteers, the Indian Central Drugs Standard Control Organisation`s Drug Controller General (DCGI) on Thursday told Sputnik, reported ANI.
Pharmaceutical giant Dr Reddy`s Laboratories has been given permission to conduct the tests, though, the date and time of the test will be determined by the company.
The vaccine is currently in its second phase of clinical trials before moving on to phase 3.
The Indian drugmaker joined hands with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine as well as its distribution.
Dr Reddy`s Lab has stated that in phase 2 clinical trial -- "it would include 100 subjects and for phase 3, it would take 1400 subjects", according to a government official.
"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 wa quoted as saying by ANI.
Around 100 million doses of its potential COVID-19 vaccine to India drug company Dr Reddy`s Lab, the RDIF said.
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 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. It has been developed jointly by RDIF and the Gamaleya National Research Center of Epidemiology and Microbiology.