Need More Data For Sputnik V Emergency Nod: Indian Drug Regulator
The Committee has asked Dr Reddy’s Laboratories to present additional data of immunogenicity as part of review.
The Central Drugs Standard Control Organisation's (CDSCO) Subject Expert Committee (SEC) asked Dr Reddy's Laboratories to present additional data of immunogenicity during the review of their application seeking emergency use approval (EUA) for Russia’s Sputnik V vaccine on Wednesday, 24 February.
The Committee held a meeting on Wednesday, 12 pm to review Dr Reddy’s Laboratories application who had presented the safety profile of the Phase 2 study, and interim data of the Phase 3 study, reported IANS.
Upon approval, the final decision will be made by the Drug Controller General of India (DCGI).
Sputnik V has been developed by Russia’s Gamaleya National Research Institute of Epidemiology and Microbiology, and is one amongst three vaccines in the world to have an efficacy of 91.6 percent as observed by The Lancet, a medical Journal, and have authorisation across 26 countries.
Russia registered the vaccine on 11 August 2020, making it the first in the world to be manufactured. A month later, Dr Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to acquire distribution rights and hold vaccine trials in India, noted IANS.
It will be the first foreign vaccine approved in India. So far, the DCGI has approved two vaccines for emergency use -- Serum Institute of India and Oxford’s COVID-19 vaccine, Covishield and Bharat Biotech’s Covaxin. The Committee also asked Covaxin to submit the efficacy data to review as part of their application to hold vaccine trials on children, added the report.
(With inputs from ANI and IANS)
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