Dr Reddys Labs Gets Dcgi Approval To Begin Phase 3 Trial For Sputnik V Vaccine In India

Dr Reddy&Rsquo;S Laboratories Ltd Announced That It Has Received Approval From The Drugs Control General Of India (Dcgi) To Conduct Phase 3 Clinical Trial For The Sputnik V Vaccine In India.The Phase 3 Study Of Sputnik V Will Be Conducted On 1,500 Subjects As Part Of The Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study In India.Earlier, The Data And Safety Monitoring Board (Dsmb) Reviewed The Safety Data From The Phase 2 Clinical Trial Of The Vaccine And Recommended The Phase 3 Recruitment. In Its Report, The Dsmb Concluded That No Safety Concerns Were Identified And The Study Met The Primary Endpoints Of Safety.G V Prasad, Co-Chairman And Managing Director, Dr Reddy&Rsquo;S Laboratories Said, &Ldquo;This Is An Important Milestone In The Progress Of This Pivotal Clinical Trial Of The Vaccine. We Expect To Commence The Phase 3 Study Within This Month And Will Continue To Fast-Track Our Efforts To Bringing In A Safe And Efficacious Vaccine For The Indian Population&Rdquo;.In September 2020, Dr Reddy&Rsquo;S Partnered With Russian Direct Investment Fund (Rdif) To Conduct The Clinical Trials Of The Sputnik V Vaccine And For Its Distribution Rights In India.Sputnik V Developed By The Gamaleya National Research Institute Of Epidemiology And Microbiology Was Registered By The Ministry Of Health Of Russia And Became The World&Rsquo;S First Registered Vaccine Against Covid-19 Based On The Established Human Adenoviral Vector Platform. The Vaccine&Rsquo;S Efficacy Is Confirmed At 91.4% Based On Data Analysis Of The Final Control Point Of Clinical Trials In Russia. Currently, The Vaccine&Rsquo;S Clinical Trials Are Underway In The Uae, Egypt, Venezuela And Belarus While It Has Been Registered In Algeria, Argentina, Belarus, Bolivia And Serbia For Inoculation.

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