DCGI grants Serum Institute permission to manufacture Sputnik V for specific regulatory purposes

FPJ News ServiceUpdated: Friday, June 04, 2021, 11:36 PM IST
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A health worker prepares a dose of the Sputnik V vaccine against the Covid-19 during a vaccination day promoted by the municipality and supported by the state government in Caracas, on June 3, 2021. | (Photo by AFP)

New Delhi: The Drug Controller has granted permission to the Serum Institute of India (SII) to manufacture the Sputnik COVID-19 vaccine in India.

The Russian jab is registered for use in more than 65 countries but has yet to be approved by the EU or US health authorities. At 91.6 per cent, Sputnik V has a higher efficacy compared to the two vaccines that are currently being administered in India - Oxford-AstraZeneca's Covishield, also manufactured by the SII, and Bharat Biotech's Covaxin.

The Pune-based SII is collaborating with Gamaleya Research Institute of Epidemiology and Microbiology, Moscow, for developing Sputnik V at its licensed Hadapsar facility. This licence, unless suspended or revoked, will be in force for three years from the date of its issuance on June 4.

Serum Institute is already producing the Oxford AstraZeneca Covid-19 vaccine under the name 'Covishield' and has told the government it will supply 10 crore doses of it in June.

Sputnik is named after a Soviet era satellite; trial results published in the medical journal The Lancet said that with two doses, it is more than 90 per cent effective in symptomatic cases.

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