Expert panel recommends emergency use of Dr Reddy's Sputnik V vaccine in India
Dr Reddy's which has collaborated with Russia's sovereign fund RDIF conducted the bridge trial for Sputnik V, has applied for emergency use. If approved by DCGI, this will be third vaccine to be available in India.
April 12, 2021 / 05:36 PM IST
Representative image (Reuters)
The Subject Expert Committee (SEC) advising the Drug Controller General of India (DCGI) has recommended Russia's Sputnik V for emergency use authorisation in India.
Dr Reddy's spokesperson confirmed the development. The DCGI will decide on the SEC recommendation.
“RDIF confirms it is awaiting imminently the recommendation by the Subject Expert Committee (SEC) of Central Drugs Standard Control Organization (CDSCO) of India to approve the use of the Russian Sputnik V vaccine against coronavirus in India,” Russia's sovereign fund RDIF said in a statement.
Dr Reddy's, which has collaborated with RDIF, conducted the bridge trial for Sputnik V and has applied for emergency use. If approved by the DCGI, this will be the third vaccine to be available in India.
India is currently using Serum Institute of India's Covishield and Bharat Biotech's Covaxin.
Dr Reddy's earlier said it will import the vaccine initially and later would produce the over 250 million doses of the vaccine. RDIF has also tied up with several Indian contract manufacturers such as Hetero, Panacea Biotec, Strides, Gland Pharma and Virchow Biotech. The deals would put the potential production capacity of Sputnik V vaccine in India to 1.5 billion doses. Some of the production will be used for exporting the vaccine.
In India, Dr Reddy's conducted bridge trial inearly 1,600 persons aged between 18 and 99.
Named after the first space satellite of erstwhile Soviet Union, Sputnik V was approved by the regulators in Russia back in August 2020. The vaccine is based on a weakened COVID-19 virus delivering parts of a pathogen that triggers an immune response in the body.
The vaccine has a proven efficacy rate of 91.5 percent.
The cost of Sputnik V, in the international market, is $10 per shot. The vaccine is required to be taken in two doses. It can be stored in dry form at temperature ranging from 2 to 8 degrees.
Sputnik V is now approved for use in 59 countries globally.