DCGI nod for phase 3 trials for Sputnik V vaccine

Dr. Reddy’s Laboratories has received Drugs Controller General of India (DCGI) approval to conduct phase 3 clinical trial for Russia’s COVID-19 vaccine candidate, Sputnik V, in the country.

The phase 3 trial will be conducted on 1,500 subjects as part of the randomised, double blind, parallel group, placebo controlled study in India, the Hyderabad-headquartered drugmaker said. Dr. Reddy’s and Russian Direct Investment Fund (RDIF) had announced a partnership in September on clinical trials for Sputnik V and its distribution rights in India.

“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,” Dr. Reddy’s co-chairman and MD G.V. Prasad said in a statement on Friday.

The Subject Expert Committee of Central Drugs Standard Control Organisation, to which Dr. Reddy’s had presented the safety data from phase 2 of Sputnik V, noted the “interim safety and immunogenicity results from the ongoing phase II of the Phase II/III clinical trial.” After detailed deliberation, the committee recommended for continuation of the clinical trial as per approved protocol.

Dr. Reddy’s had recently announced that the Data and Safety Monitoring Board (DSMB) had reviewed the safety data from the phase 2 and recommended the phase 3 recruitment. According to the release, the DSMB, in its report, concluded that no safety concerns were identified and the study met the primary endpoints of safety.

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Printable version | Mar 6, 2021 4:50:41 PM |

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