Expert panel recommends approval to Russia's Sputnik V Covid-19 vaccine

India is set to soon have a third Covid-19 vaccine – Sputnik V from Russia. The expert panel reviewing Dr Reddy’s Laboratories’ (DRL’s) application for approval to the Russian vaccine candidates has recommended that approval be given to this human adenovirus (flu virus)-based vaccine. Now, the Drugs Controller General of India (DCGI) will consider this recommendation and decide whether to grant Sputnik V approval for restricted emergency use in India.

 

The other two vaccines – Covishield by Serum Institute and Covaxin by Bharat Biotech – that were recommended for grant of approval by the subject expert committee (SEC) were approved by the DCGI within days.

 

Sputnik V has been registered in 59 countries globally with a total population of over 1.5 billion people. The efficacy of Sputnik V is 91.6 per cent.

 

Sputnik V will be manufactured in India by several companies including Hetero, Gland Pharma, Stelis Pharma, Virchow Group, etc, and a total production capacity of over 900 mn has been lined up. The Russian Direct Investment Fund (RDIF) plans to export the bulk of this capacity and, according to DRL, RDIF’s Indian partner, about 250 mn doses would be for India.

 

According to sources, more players like Pune-based Serum Institute and Shilpa Medicare are also likely manufacturing partners; talks are on. The total capacity for making Sputnik V in India can thus cross one billion doses annually, much ahead of the other vaccine candidates.

 

Sputnik V requires a minus 18-20 degree Celsius cold chain to remain stable. Work is on to come up with a lyophilised (or freeze dried) version of the vaccine; it will enable the vaccine to remain stable in 2-8 degree Celsius.

 

As Russian Covid19 vaccine Sputnik V nears entry into the Indian market, now one of the largest drug firms in the country, Mankind Pharmaceuticals is likely to partner with the RDIF for distributing the vaccine in India.

 

Sources further indicated that Sputnik V might be priced at Rs 500 per dose when it is commercially available in the private market in India. The Indian government and RDIF, however, will negotiate on prices at which the government will procure the vaccine for the national Covid-19 immunisation drive.


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