Dr Reddy's Laboratories has reapplied for the permission of Drugs Controller General of India (DCGI) to conduct combined phase 2 and phase 3 trials of the Russian coronavirus vaccine candidate Sputnik V in India. The pharma giant has submitted a revised protocol for carrying out clinical trials. This will be a multi-centre, observer-blind, randomised and controlled study.
Earlier this month, the Central Drugs Standard Control Organisation's (CDSCO) Subject Expert Committee on COVID-19 had asked the pharma firm to re-apply stating that it cannot directly conduct phase 3 trials of the vaccine in India after due deliberations. The CDCSO SEC panel suggested that the Russian COVID-19 vaccine should be tested for safety and efficacy in a smaller trial.
The panel added safety and immunogenicity data from overseas had a smaller number of participants and there is no data available for the effects of Sputnik V on Indians. Dr Reddy's had sought permission from the DCGI to conduct phase 3 trials of the potential vaccine against COVID-19.
Dr Reddy's has teamed up with Russian Development Investment Fund (RDIF) to conduct trials and distribute 100 million doses of Sputnik V in India. Sputnik V has been jointly developed by the Gamaleya National Research Centre of Epidemiology and Microbiology and RDIF.
Meanwhile, India is the second worst affected nation due to coronavirus globally as its case tally has surpassed the 72-lakh mark today. Out of these cases, 8, 26,876 are active COVID-19 cases while 63, 01,927 people have recovered from COVID-19. According to the Health Ministry's COVID-19 dashboard, 1,10,586 people have succumbed to novel coronavirus so far.
Edited with PTI inputs