After the Subject Expert Committee (SEC) on COVID-19 on Monday recommended granting approval to Sputnik V for restricted emergency use, the Drug Controller General of India (DCGI) has now approved the use of Russia's Sputnik V vaccine against the COVID-19 virus. Before the Sputnik V vaccine was approved, the DCGI had already granted emergency use authorisatrion to two COVID-19 vaccines – indigenously developed Covaxin from Bharat Biotech, and Oxford-AstraZeneca's Covishield, manufactured by Serum Institute of India.
Drugmaker Dr Reddy's Laboratories had sought emergency use authorisation for the Russian vaccine. Earlier in Septemer 2020, the company had entered into a partnership with the RDIF to conduct the clinical trials of the Sputnik V vaccine and for its distribution in India.
"The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces that Drug Controller General of India (DCGI) has approved the use of the Russian Sputnik V vaccine against coronavirus in the country," the RDIF said in a statement.
The vaccine has been registered in India under the emergency use authorisation procedure based on results of clinical trials in Russia as well as positive data of additional phase 3 local clinical trials in India conducted in partnership with Dr Reddy's Laboratories, according to the company.
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. It needs a storage temperature of 2-8 degree C, implying it can be stored in conventional refrigerators without any need to invest in additional cold-chain infrastructure, making storage and transportation easy.