An expert panel from India’s Central Pharmaceuticals Authority has recommended granting approval of the Russian COVID-19 Sputnik V vaccine for emergency use in the country under certain conditions, sources said.
The Central Drugs Standard Control Organization (CDSCO) Committee of Experts on the Subject (SEC) on Monday addressed the request from Dr Reddy’s Laboratories for emergency use authorization for Sputnik V.
India’s Comptroller General of Medicines (DCGI) will take a final appeal on the recommendation. If approved, it will be the third COVID-19 vaccine available in India.
The vaccine would be imported from Russia for emergency use in the country, they said.
In September last year, Dr Reddy partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials on Sputnik V and for its distribution rights in India.
The Comptroller General of Medicines of India (DCGI) has already given emergency use authorization for two COVID-19 vaccines – Covaxin from Bharat Biotech and Covishield from Oxford-AstraZeneca, being manufactured by Serum Institute of India in Pune. (Click here to follow all developments related to Covid-19)
Sputnik V demonstrated an efficacy rate of 91.6% in the interim analysis of the Phase 3 clinical trial, which included data from 19,866 volunteers in Russia.