Sputnik V gets DCGI expert panel approval

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As the country grapples with surging Covid-19 cases and vaccine shortage, a panel of experts has recommended Russia’s Covid vaccine Sputnik V for use in India with certain conditions.

If approved by the regulator, Drug Controller General of India (DCGI), this will be the third vaccine to be used in India after Serum Institute of India’s Covishield — developed by Oxford-AstraZeneca — and Bharat Biotech’s Covaxin.

Sources in the Government said that the Subject Expert Committee (SEC) of the DCGI on Monday took up the application of Dr Reddy’s Laboratories seeking emergency use authorisation for Sputnik V.

The DCGI will take a final call on the recommendation. The vaccine would be imported from Russia for emergency use in the country, the sources said.

The DCGI has already given the emergency use authorisation for two Covid19 vaccines — Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca manufactured by Serum Institute of India in Pune.

In September last year, Dr Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of Sputnik V and for its distribution rights in India.

Sputnik V uses two different disarmed strains of the adenovirus, a virus that causes the common cold, as vectors to deliver the vaccine dose. It is 91.6% effective against symptomatic Covid-19 in the interim analysis of phase 3 clinical trial, which included data on 19,866 volunteers in Russia.

Following record increase in Covid cases and in view of the shortage of two vaccines-Covishield and Covaxin which are being administered presently under the nationwide vaccination programme, health experts had been asking the Government to give approval to other shots as well to meet the vaccine need in the country.

Recently, Prime Minister Narendra Modi had exhorted the States to ramp up the vaccination drive against the deadly COVID-19 infection by launching the four-day “Tika Utsav” (vaccination festival) that kicked off on Sunday. PM Modi in his meeting with Chief Ministers and representatives of all States and Union Territories (UTs) had said that India should focus on mass-scale vaccination and micro-containment zones to control the spread of the pandemic.

Daily Pioneer
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