DCGI nod for phase 3 trials for Sputnik V vaccine
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Dr. Reddy’s Laboratories has obtained Drugs Controller General of India (DCGI) approval to conduct phase 3 medical trial for Russia’s COVID-19 vaccine candidate, Sputnik V, within the nation.
The phase 3 trial shall be performed on 1,500 topics as a part of the randomised, double blind, parallel group, placebo managed examine in India, the Hyderabad-headquartered drugmaker mentioned. Dr. Reddy’s and Russian Direct Investment Fund (RDIF) had introduced a partnership in September on medical 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 mentioned in an announcement on Friday.
The Subject Expert Committee of Central Drugs Standard Control Organisation, to which Dr. Reddy’s had offered the security information from phase 2 of Sputnik V, famous the “interim safety and immunogenicity results from the ongoing phase II of the Phase II/III clinical trial.” After detailed deliberation, the committee beneficial for continuation of the medical trial as per accredited protocol.
Dr. Reddy’s had just lately introduced that the Data and Safety Monitoring Board (DSMB) had reviewed the security information from the phase 2 and beneficial the phase 3 recruitment. According to the discharge, the DSMB, in its report, concluded that no security considerations had been recognized and the examine met the first endpoints of security.
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