DCGI approves emergency use of Russia's Sputnik V; 3rd vaccine to get nod in India

The Drugs Controller General of India has granted approval to Russia's coronavirus vaccine Sputnik-V for restricted use in India, the Russian Direct Investment Fund said on Tuesday. Developed by Russia's Gamaleya Research Institute of Epidemiology and Microbiology, Sputnik V is the third COVID-19 vaccine approved by the Subject Expert Committee (SEC) and the DCGI after Covishield and Covaxin vaccines. As per the Russian fund, the price of Sputnik V is less than $10 per shot but it is yet to come up with the final price specifically for India. Limited doses of the Russian vaccines could be available by month-end only.

The decision was taken after the SEC held a meeting on Monday to consider Sputnik V's application for emergency use authorisation (EUA) in India. With this approval, India has become the 60th country to approve Sputnik V vaccine. Hyderabad-based pharma giant Dr Reddy's Laboratories had last week sought the Centre's nod for the vaccine to be used in India. The RDIF joined hands with Dr Reddy's in September 2020 to carry out clinical trials of Sputnik V in India.

The Sputnik V vaccine is based on a proven platform of human adenoviral vectors, which cause the common cold and have been around for thousands of years. 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.

"We appreciate the decision of India's regulatory bodies to grant authorisation for Sputnik V. Approval of the vaccine is a major milestone as Russia and India have been developing an extensive cooperation on clinical trials of Sputnik V in India and its local production," Kirill Dmitriev, CEO of the Russian Direct Investment Fund has said.

Dmitriev said India is a vaccine-manufacturing hub and RDIF's strategic partner for production of Sputnik V. "Over 850 million doses of Sputnik V are going to be produced in India annually sufficient to vaccinate more than 425 million people around the world," he said.

India is the leading production hub for Sputnik V. RDIF has signed pacts with Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, Virchow Biotech to produce millions of vaccines per year. Sputnik V ranks second among coronavirus vaccines globally in terms of the number of approvals issued by government regulators.

The Russian jab has an efficacy rate of 91.6 per cent and is carrying out its phase-3 clinical trials in Belarus, UAE, India, and Venezuela, according to Sputnik-V's website. As more and more states flag shortages of coronavirus vaccine doses, the Centre has pressed the accelerator to expand vaccine production manifold. With a manufacturing capacity of 850 million doses in India, Sputnik V will prove to be a major shot in the arm in the fight against coronavirus, suggest experts.

Apart from India, Sputnik V has also been approved in Russia, Argentina, Venezuela, UAE, Iran, Mexico, Pakistan, Egypt, Sri Lanka, Iraq, Kenya, Morocco, Jordan, Azerbaijan, Philippines, Mauritius, Vietnam, among others.

Also Read: COVID-19: Panacea Biotec to produce 100 million doses of Sputnik V in India annually

Also Read: COVID-19 vaccine: Drug regulator seeks additional data from Dr Reddy's on Sputnik V

Also Read: India badly needs Sputnik V in fight against COVID-19