India may begin Sputnik vaccine import by May; start production around July
Russian made Coronavirus disease (Covid-19) vaccine, Sputnik V, is likely to be imported to India by the next month, according to people aware of the matter.
The local production, through various tie-ups, could start by the end of June or early July, according to Kirill Dmitriev, CEO, Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund that is marketing the vaccine globally.
Dr Reddy’s Labs, that has the license to distribute the vaccine, on Tuesday received India’s drugs controller’s approval for import of the vaccine under restricted use in emergency situation, making it the third vaccine allowed for use in India against Covid-19.
Apart from partnership with Dr Reddy’s Labs that is conducting Sputnik V clinical trials locally, and have the distribution rights for the Russian vaccine, RDIF has entered manufacturing partnership with five other local companies for production.
The companies are: Stelis Biopharma, Gland Pharma, Hetero Biopharma, Panacea Biotec and Virchow Biotech.
India will be producing at least 50 million doses of Sputnik V per month, over the next couple of months.
“We are looking at producing 50 million doses or more a month of Sputnik V by this summer, or end of summer, in India. India has a significant production capacity; we have already announced tie-ups with five local companies for mass production of Sputnik V, and we intend to have several more tie-ups that will announce soon; likely in the next two weeks,” said Dmitriev.
“The India trial of Sputnik V has shown a high level of immune response; also Sputnik has high-level of safety and efficacy profile in the real world, not only in Russia but also Argentina, Mexico and other countries where the vaccine is being used. Sputnik is one of the three vaccines with more than 90% efficacy,” he added.
The vaccine’s efficacy is pegged at 91.6% based on the final assessment of clinical trials in Russia, where roughly 20,000 people were part of the phase 3 clinical trials. In India, the vaccine is being tested in 1,600 people in a phase 2/3 trial meant as a “bridging study” that all foreign-made pharmaceutical products need to undergo.
He also said that the day approval was granted by the Indian government to Sputnik V (April 12) was significant as big space day for the Russians, for 16 years ago Russia’s Yuri Gagarin was the first cosmonaut to reach space.