Drug firm Dr Reddy's Laboratories on Friday said it has initiated the process with the Drugs Controller General of India (DCGI) for emergency use authorisation (EUA) for Russia's Sputnik V vaccine against COVID-19.
"As part of the review process, Dr Reddy's will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by 21st February 2021," the company said in a release.
Sputnik V, the human adenoviral vector-based platform vaccine candidate developed by Russia's Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by the Ministry of Health of Russia on August 11, 2020.
In September 2020, Dr Reddy's partnered with the Russian Direct Investment Fund (RDIF) to conduct the clinical trials of Sputnik V, and for its distribution rights in India.
"Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of the phase 3 clinical trial, which included data on 19,866 volunteers in Russia, who received both the first and second doses of the vaccine," the release said.
Sputnik V maintained a consistent efficacy at 91.8 per cent even among the group of 2,144 volunteers over 60 years old.
"More than 250 clinical studies over two decades have proven the safety, efficacy, and lack of negative long-term effects of adenoviral vaccines," Dr Reddy's said, adding that Sputnik V has been authorised in 26 countries and administered to more than 2 million people globally.
"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 Co-chairman and Managing Director G V Prasad said.
In early January, India approved Serum Institute's Covishield and Bharat Biotech's Covaxin. Both the vaccines are currently being administered as part of the country's vaccination campaign against COVID-19 pandemic. If granted EUA, Sputnik V will become the third vaccine against COVID-19 to be approved in the country.
On Friday, shares of Dr Reddy's closed 1.46 per cent higher at Rs 4,685.15 on the BSE.