Recommendation for Emergency Use Authorisation granted to SPUTNIK V by the Indian Authorities. India to get the third vaccine against the Chinese Corona Virus (COVID19).
Govt approves the Sputnik vaccine. It shall be manufactured by Dr Reddy’s laboratories for India. The vaccine, sputnik-V has a 91.6% efficacy and is registering more than 50 countries.
Dr Reddy’s Laboratories has a tie-up with the Russian Direct Investment Fund, which backed the development of Sputnik V, and will import the initial doses of the vaccine once it gets approval from the drug regulator. Subsequent doses of the vaccine will be manufactured in India.
The government procures the Covishield vaccine from Serum Institute of India and Covaxin from Bharat Biotech at 150 per dose.
RDIF and Dr Reddy’s said in September that they will cooperate on clinical trials and the supply of 100 million doses of Sputnik V vaccine to India.
“In the initial days, the plan is to import the product from Russia by Dr Reddy’s, depending on what quantities they can get into the country. Then Indian manufacturers will co- me in to play, manufacture it and provide it to Dr Reddy’s for marketing,” said an industry
executive Prices of Sputnik V are expected to drop when local production starts.
“The local manufacturers will be able to scale it up. The combined capacities of those manufacturing Sputnik V will be much larger than that of any of the vaccine manufacturing- rivers in India,” the government official said.
However, local manufacturers may have to carry out bridging trials before the vaccine can be approved for use in India. A bridging trial is a study conducted in a new region or country that builds on clinical data from anot her region.
“The bridging trials are mandatory under the law and so far such trials have not been waived… We will have to see if the regulator makes some changes like allowing a common trial,” a company executive said on conditioning of anonymity.
Dr Reddhas conducted a bridging trail involving about 1,500 participants to check the safety and immunogenicity of the Sputnik V vaccines that will be imported.
Sputnik V’s efficacy is confirmed at 91.6% and it is one of three vaccines with an efficacy of over 90%. It was the first Covid-19 vaccine to be registered globally and has approved ved for use in 55 countries. The vaccine was developed by the Gamaleya National Research Centre for Epidemiology Microbiology in Moscow with backing from RDIF, Asia’s sovereign wealth fund.
With inputs from Times Group, Social Media,Sputnik V,GOI
