Russia's Sputnik V Covid-19 vaccine to first be tested on 100 Indians: Report

Dr Reddy's Laboratories said it has received approval from the DCGI to conduct phase 2/3 human clinical trials for Sputnik-V

Representative image/Credit: Reuters Photo

The Russian Sputnik V vaccine is to be tested on 100 volunteers in India, according to multiple media reports.

The vaccination will be tested on 100 participants, the Indian Central Drugs Standard Control Organisation's Drug Controller General (DCGI) told Sputnik, an ANI report said.

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Dr Reddy's Laboratories on Saturday said it along with Russian Direct Investment Fund (RDIF) has received approval from the DCGI to conduct phase 2/3 human clinical trials for Covid-19 vaccine Sputnik V in India.

“The firm should generate safety and immunogenicity data on 100 subjects in Phase II clinical trial and submit for evaluation before proceeding to Phase III clinical trial,” the SEC decided in a meeting on 16 October, according to a document uploaded on the Central Drugs Standard Control Organisation’s (CDSCO) website.

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This will be a multi-centre and randomised controlled study, which will include safety and immunogenicity check, the Hyderabad-based drug major said in a statement.

Earlier in September 2020, Dr.Reddy's and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr.Reddy's upon regulatory approval in India.

(With inputs from Agencies - Reuters, PTI)