Dr. Reddy’s gets nod for Sput­nik V tri­als

The Hindu - - FRONT PAGE - Spe­cial Cor­re­spon­dent

Pharma ma­jor Dr. Reddy’s Lab­o­ra­to­ries and Rus­sia’s sovereign wealth fund RDIF have re­ceived ap­proval from the Drugs Con­troller Gen­eral of In­dia to con­duct an adap­tive phase 2/3 hu­man clin­i­cal trial for the Sput­nik V vac­cine in In­dia. It is the world’s first reg­is­tered vac­cine against COVID-19.

This will be a mul­ti­cen­tre and ran­domised con­trolled study, which will in­clude safety and im­muno­genic­ity study.

De­vel­oped by Ga­ma­leya Na­tional Re­search In­sti­tute of Epi­demi­ol­ogy and Mi­cro­bi­ol­ogy, Rus­sia, Sput­nik V vac­cine is based on the hu­man ade­n­ovi­ral vec­tors plat­form. The vac­cine was reg­is­tered by Rus­sia’s Health Min­istry in Au­gust.

The DCGI ap­proval “is a sig­nif­i­cant de­vel­op­ment that al­lows us to com­mence the clin­i­cal trial in In­dia. We are com­mit­ted to bring­ing in a safe and ef­fi­ca­cious vac­cine to com­bat the pan­demic,” Dr. Reddy’s Co-chair­man and Man­ag­ing Direc­tor G.V. Prasad said in a state­ment is­sued by the com­pany and RDIF.

Rus­sian Di­rect In­vest­ment Fund (RDIF) CEO Kir­ill Dmitriev said, “We are pleased to col­lab­o­rate with the In­dian reg­u­la­tors and in ad­di­tion to In­dian clin­i­cal trial data, we will pro­vide safety and im­muno­genic­ity study from the Rus­sian phase 3 clin­i­cal trial. This data will fur­ther strengthen the clin­i­cal de­vel­op­ment of Sput­nik V vac­cine in In­dia.”

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