The Russian government has reached out to India seeking collaboration for manufacturing its COVID-19 vaccine ‘Sputnik V’ and conducting its phase 3 clinical trial here, sources said.
According to government sources, the matter was discussed by the national expert group on vaccine administration for COVID-19 in its meeting held on August 22.
Sputnik V has been developed by the Gamaleya Research Institute of Epidemiology and Microbiology along with the Russian Direct Investment Fund (RDIF). The vaccine has not been tested in phase 3 or larger clinical trials.
There has been scepticism in some quarters about limited data related to the efficacy of the vaccine.
“The Russian government has reached out to the Indian government seeking collaboration for manufacturing their COVID-19 vaccine, Sputnik V, and conducting its phase 3 trial here,” a source in the government said.
“The Department of Biotechnology (DBT) along with the Department of Health Research has been asked to lead and look into the matter. They (Russian government officials) have shared some information and data on Sputnik V, while more data related to the safety and efficacy of the vaccine is awaited,” the source said.
When asked if the Russian government has placed any formal request for the manufacture of its COVID-19 vaccine in India, Union Health Secretary Rajesh Bhushan said at a press conference, “As far as Sputnik V vaccine is concerned, both India and Russia are in communication. Some initial information has been shared while some detailed information is awaited.” According to sources, Russian Ambassador to India Nikolay Kudashev has approached the office of Principal Scientific Advisor K VijayRaghavan as well as secretaries of the departments of biotechnology and health research in this regard.
Talking about COVID-19 vaccine development in India, ICMR Director General Balram Bhargava said, at a press briefing, on Tuesday that currently two vaccine candidates, indigenously developed by Bharat Biotech in collaboration with ICMR and Zydus Cadila Ltd, have completed phase 1 of the human clinical trials and they will start phase 2 trials.
Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, has also started the process of conducting phase 2 and 3 human clinical trials of the candidate in India.