Dr Reddy’s starts cycle to acquire obtain emergency use authorisation for Sputnik V
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- Source: PTI
- Date: 19 Feb,2021
Dr Reddy’s Laboratories on Friday said it has approached drugs regulator DCGI for emergency use authorisation (EUA) for COVID-19 vaccine Sputnik V.
As part of this review process, the medication major will present the safety profile of phase 2 study, and interim information of phase 3 trial, which is expected to be complete by February 21, 2021, Dr Reddy’s said in a statement.
In September last year, the Hyderabad-based firm partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of Sputnik V and for its distribution rights in India.
The vaccine is undergoing phase 3 clinical trial in India. The Drugs Controller General of India (DCGI) has already given the EUA nod for two COVID-19 vaccines — Covaxin of Bharat Biotech and Covishield of Oxford-AstraZeneca, being fabricated by Serum Institute of India in Pune.
The vaccines are being administered to frontline workers across the country. Sputnik V has demonstrated an efficacy rate of 91.6 percent in the interim analysis of phase 3 clinical trial, which contained information on 19,866 volunteers in Russia, the announcement said.
The vaccine also maintained a consistent efficacy at 91.8 percent even among the group of 2,144 volunteers over 60 years old. “The efficacy of Sputnik V was reported to be 91.6 per cent by the Lancet, which is an impressive development in the struggle against COVID-19. The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India,” Dr Reddy’s Laboratories Co-chairman and Managing Director G V Prasad explained.
Sputnik V has already receivedapproval in 26 countries and has been administered to more than 2 million individuals globally.