The Drugs Controller General of India (DCGI) has given nod to conduct phase 3 clinical trial of Russia’s COVID-19 vaccine candidate, Sputnik V, in India, according to Dr. Reddy’s Laboratories.
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. The trial will be conducted on 1,500 participants as part of the randomised, double blind, parallel, placebo controlled study.
“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.
The interim safety and immunogenicity results from the ongoing phase II of the phase II/III clinical trial was submitted to the Subject Expert Committee of Central Drugs Standard Control Organisation, India. After detailed deliberation, the committee recommended for continuation of the clinical trial as per approved protocol, said the company.