New Delhi: 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 the review process, the drug major will present the safety profile of phase 2 study, and interim data of phase 3 trial, which is expected to be complete by February 21, 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 manufactured 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 per cent in the interim analysis of phase 3 clinical trial, which included data on 19,866 volunteers in Russia, the statement said.
The vaccine also maintained a consistent efficacy at 91.8 per cent 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 fight 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 said.