Clinical trials of Sputnik V vaccine begins in India

New Delhi: Phase 2/3 clinical trials for Sputnik V, the first registered Covid-19 vaccine from Russia commenced in India on Tuesday.

Russian Direct Investment Fund (RDIF) and Dr Reddy’s Laboratories today said they have commenced adaptive Phase 2/3 clinical trials for the vaccine.

Russia became the first country to register the world’s first Covid-19 vaccine on August 11. Sputnik V was developed by the Gamaleya National Research Centre for Epidemiology and Microbiology of the Russian Healthcare Ministry.

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The Sputnik V vaccine is based on a well-studied human adenoviral vector platform that had proven safe and effective with no long-term side effects in more than 250 clinical trials globally conducted during the past two decades (while the history of use of human adenoviruses in vaccine development started in 1953). More than 100,000 people have received approved and registered drugs based on the human adenoviral vectors.

Last month, Russia on Wednesday said that its vaccine Sputnik V is 92 per cent effective at protecting people from COVID-19 according to the first interim analysis.

“The Sputnik V vaccine efficacy amounted to 92 per cent (calculation based on the 20 confirmed Covid-19 cases split between vaccinated individuals and those who received the placebo),” the RDIF said in a statement read.

Sputnik V vaccine against Covid-19 will be tested in India on 100 volunteers, the Indian Central Drugs Standard Control Organisation’s Drug Controller General (DCGI) told Sputnik in October.

DCGI has granted permission to pharmaceutical giant Dr Reddy’s Laboratories for conducting tests.

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