India is set to get its third COVID-19 vaccine as the Central Drugs Standard Control Organisation (CDSCO) expert panel on Monday recommended granting approval to Russian COVID-19 vaccine Sputnik V for emergency use in India, sources told news agency PTI. Pharma major Dr Reddy's has partnered with the Russia Direct Investment Fund (RDIF) to bring the Sputnik V vaccine to India. The Drugs Controller General of India (DCGI) will now have to formally approve the vaccine for use in India.
According to data put out by the Russian government, Sputnik V vaccine has shown 92 per cent efficacy in preventing COVID-19. The vaccine's efficacy is confirmed at 91.4%, based on data analysis of the final control point of clinical trials in Russia. Currently, Sputnik V is being administered as part of emergency use in 12 countries. The vaccine has been named Sputnik-V, as a reference to the surprise 1957 launch of the world's first satellite by the Soviet Union.
An official from Dr Reddy’s had earlier said that Sputnik V is a two dose vaccine, one can take the first dose on day zero and the second one on day 21. Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world's first registered vaccine against COVID-19 based on the established human adenoviral vector platform.
In January, Dr Reddy's Laboratories Ltd had announced that it had received approval from the Drugs Control General of India (DCGI) to conduct Phase 3 clinical trials for the Sputnik V vaccine in India. The Phase 3 study of Sputnik V will be conducted on 1500 subjects as part of a randomised, double-blind, parallel-group, placebo-controlled study in India, the Hyderabad-based company had said in a statement.
Hyderabad-based Virchow Biotech Private Limited (part of the Virchow Group) and the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund had in March announced the agreement to produce up to 200 million doses per year of Sputnik V vaccine against coronavirus. Gland Pharma, Panacea Biotec, Stelis Biopharma, Hetero Biopharma are the tieups they have apart from Virchow to produce the vaccine doses.
India currently has two vaccines being administered to citizens - Bharat Biotech's Covaxin and Serum Institute of India's Covishield.