Coronavirus: Once a company is finalised and India’s regulatory clearances are in place, then trials will begin with Indian volunteers for Russia’s Sputnik V COVID-19 vaccine
New Delhi, September 9:
India has received Russia’s request for conducting phase 3 human trials and manufacturing the Sputnik V coronavirus vaccine, the government said today. It said India is working to facilitate Russia’s request.
“The government of Russia reached out to the government of India through appropriate channels and sought help on two fronts. One was to consider the manufacturing of the vaccine through a network of companies that are well-known for vaccine manufacturing and of size, volume and quality that is among the very best in the world. So the intention was that this can be manufactured by Indian companies at a large scale,” said Dr VK Paul, who heads the national expert group on vaccine administration for COVID-19 and is also a member of the centre’s think tank NITI Aayog.
“The second part of the request was that they have done phase 1 and 2 trials and the results were published in The Lancet last week. They want to know whether phase 3 trials could be conducted in India and for that what regulatory clearances are needed,” Mr Paul said.
“India attaches great importance to Russia’s offer. It is an offer from a friend and one who has been a very special friend of the country. We reached out to several companies in India and three-four have responded well,” Mr Paul said.
“Once a company is finalised and our regulatory clearances are in place, then trials will begin with Indian volunteers. The coming together of both nations is a win-win situation for both India and the world since we can produce in large quantities,” he said.
The Russian Health Ministry registered the first vaccine against COVID-19, named Sputnik V, on August 11. The vaccine has been developed by Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology and triggered a “strong” immune response in phases 1 and 2 of the clinical trials on 76 people, according to researchers.
It is currently undergoing phase 3 trials in Russia. Russian Health minister Mikhail Murashko said the country will start mass inoculation from November or December, with a focus on high-risk groups.
Trials of other vaccines are going on in India. The phase 3 human trials for Oxford University’s vaccine Astra Zeneca will begin next week across 17 sites in India; 1,600 volunteers are participating.
Currently, among India’s two indigenous vaccines, Bharat Biotech’s vaccine is about to begin phase 2 trial while Zydus Cadilla’s vaccine is already in phase 2.
