Dr Reddy's seeks emergency use authorisation for Russia's Sputnik V vaccine
23 February 2021
Dr Reddy’s Laboratories today announced that it has initiated the process with the Drugs Controller General of India (DCGI) for Emergency Use Authorisation (EUA) of Russia’s Covid-19 vaccine candidate Sputnik V.
The Indian pharma major, which is authorised to manufacture and market the human adenoviral vector-based platform vaccine, said it would present the safety profile of the phase 2 study, and interim data of the phase 3 study, which is expected to complete by 21 Februart as part of the review process.
In September 2020, Dr Reddy’s partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V and for its distribution rights in India. The vaccine is currently undergoing phase 3 clinical trial in India.
Sputnik V, according to Dr Reddy’s has demonstrated an efficacy rate of 91.6 pr 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. Sputnik V maintained a consistent efficacy at 91.8 per cent even among the group of 2,144 volunteers over 60 years old, it added.
“The efficacy of Sputnik V was reported to be 91.6 pr 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,” G V Prasad, co-chairman and managing director, Dr. Reddy’s Laboratories, said.
Sputnik V, developed by the Gamaleya National Research Institute of Epidemiology and Microbiology, was registered by Russia’s ministry of health on 11 August 2020, the first Covid-19 vaccine to be registered gobally.
More than 250 clinical studies over two decades have proven the safety, efficacy, and lack of negative long-term effects of adenoviral vaccines. Sputnik V is one of only three vaccines in the world with an efficacy of 91.6 per cent and has most authorizations granted with 26 countries globally. The vaccine has already been administered to more than 2 million people worldwide.