New Delhi: The Russian Direct Investment Fund (RDIF) said Tuesday than more than 850 million doses of the Sputnik V vaccine are going to be produced annually in India. Also the approval for the emergency use of the vaccine against COVID-19 infections in India has been given.
The Drug Controller General of India (DCGI) has registered the vaccine under the emergency use authorisation procedure. This is based on results of clinical trials in Russia as well as positive data of additional Phase III local clinical trials in India. The trials were conducted in partnership with Dr Reddy’s Laboratories.
The vaccine has been approved for use in countries with a total population of three billion people or about 40 per cent of the global population. India has become the 60th country to approve Sputnik V, RDIF, Russia’s sovereign wealth fund, said in a statement. India is also the most populated country to register the vaccine. It is also the leading production hub for Sputnik V, RDIF added.
Sources said Monday that the DCGI has granted permission for the restricted emergency use of Sputnik V with certain conditions.
RDIF CEO Kirill Dmitriev said approval of the vaccine is a major milestone. This is because both countries have been developing an extensive cooperation on clinical trials of Sputnik V in India and its local production.
“The Russian vaccine has efficacy of 91.6 per cent and provides full protection against severe cases of COVID-19. The data has been published in one of the leading medical journals, ‘The Lancet’,” Dmitriev said.
Also read: Winning moment: Russian COVID-19 vaccine Sputnik V found 91.6% efficient in Phase III trial
“Over 850 million doses of Sputnik V are going to be produced in India annually. It is sufficient to vaccinate more than 425 million people around the world,” he said.
According to the release, RDIF has agreements with India’s Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma and Virchow Biotech. The agreements have been made aimed at production of more than 850 million doses per year.
As per RDIF, Sputnik V has a number of key advantages, including that there are no strong allergies caused by Sputnik V. The price of the vaccine is less than USD 10 per shot. It uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots, the RDIF added.
Other countries that have approved use of Sputnik V include Argentina, Bolivia, Hungary, UAE, Iran, Mexico, Pakistan, Bahrain and Sri Lanka.