Russias Sputnik V has got approval from the Subject expert committee (SEC) for its Emergency Use Authorisation (EUA), in India. It is the third COVID-19 vaccine to get clearance. 

The Drugs Controller General of India (DCGI)s SEC had a meeting to take up Sputnik V application for EUA in India and they approved Dr Reddys application for EUA to Sputnik V vaccine.

Last week, Dr Reddys Laboratories, had sought for the governments approval for the vaccine to be used in India. The Russian Direct Investment Fund (RDIF) had partnered with Dr Reddys in September 2020 for conducting clinical trials of Sputnik V in India.

DCGI had sought additional data from drug maker Dr Reddys Laboratories on its Sputnik V COVID-19 vaccine clinical trial.

Currently, India is manufacturing two COVID-19 vaccines, Serum Institute of Indias Oxford COVID-19 vaccine Covishield and Bharat Biotechs manufactured Covaxin.

By the end of the 3rd quarter in this year, India will get vaccines from 5 more manufacturers, said the Government sources. These vaccines are Sputnik V vaccine (with Dr. Reddys collaboration), Johnson & Johnson vaccine (with Biological E collaboration), Novavax vaccine (with Serum India collaboration), Bharat Biotechs Intranasal Vaccine and Zydus Cadilas vaccine. Safety and efficacy will be the primary concerns for granting emergency use authorisation (EUA) to any vaccine in the country.

The efficacy of Russian vaccine is 91.6 per cent. Russia has registered the Sputnik V vaccine for public use since August. The approval was given before the start of the large-scale trial in September 2020.

The EUA of Sputnik V has arrived when India is facing the 2nd wave of coronavirus pandemic with an increasing number of cases every day.

Source: ET Healthworld