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Kerala Kaumudi Online
Thursday, 06 May 2021 5.51 AM IST

India likely to get 3rd COVID-19 vaccine soon, expert panel to take call on Sputnik V at key meet today

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NEW DELHI: India is likely to get a third vaccine against the novel coronavirus very soon as the Subject Expert Committee (SEC), constituted by the Central government, will meet today to consider granting approval for the emergency use of Russia’s Sputnik V vaccine in India.

The expert panel of India’s central drug authority had earlier this month sought additional data and information from drugmaker Dr Reddy’s Laboratories, which has sought emergency use authorisation for the Russian COVID-19 vaccine.

Dr. Reddy’s Laboratories had last month submitted the immunogenicity data the panel had asked in the first meeting on February 24.

The SEC, which had last deliberated on the emergency use authorisation (EUA) application on April 1, recommended that the firm should present data pertaining to all immunogenicity parameters, unblinded data of serious adverse events and RT-PCR positive cases, along with causality analysis reported till date for further examination.

“It has also asked the Hyderabad-based firm to submit a comparative analysis of the phase 3 immunogenicity data generated on the Indian and Russian studies at various time points. It has also asked the drug-maker to submit the factsheet,” a source was quoted as saying by PTI.

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

Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of phase 3 clinical trial, which included data on 19,866 volunteers in Russia.

The Drugs Controller General of India (DCGI), India's drug regulator, has already approved two COVID-19 vaccines – indigenously developed Covaxin from Bharat Biotech, and Oxford-AstraZeneca's Covishield, manufactured by Serum Institute of India – for restricted emergency use in the country.

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TAGS: COVID VACCINE, KERALA, INDIA, COVID 19, EXPERT PANEL, SPUTNIK 5, RUSSIA
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