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, 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 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.
Sputnik V developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia on August 11, 2020 and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vector platform.
Sputnik V has already received approval in 26 countries and has been administered to more than 2 million people worldwide.
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