Russian COVID-19 vaccine Sputnik V's phase 2 and 3 clinical trials begin in India

The clinical trials for Russia's first registered COVID-19 vaccine Sputnik V commenced in India on Tuesday, December 1. Dr. Reddy’s Laboratories and the Russian Direct Investment Fund (RDIF) announced starting adaptive phase 2 and 3 clinical trials for the vaccine. Russia became the first country to register the world`s first COVID-19 vaccine on August 11.

Last month, Russia claimed that its indigenous COVID-19 vaccine showed 92 percent efficacy against the virus according to the first interim analysis. So far, at least 100,000 people have received the approved and registered drugs based on the human adenoviral vectors.

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

READ | Sputnik V's two-dose COVID-19 vaccine to cost less than $20 globally, free for Russians

Drugs Controller General of India (DCGI) has granted permission to pharmaceutical giant Dr. Reddy`s Laboratories for conducting the drug trial in the country. As per reports, the vaccine will be tested in India on 100 volunteers.

The COVID-19 vaccine has been developed by the Gamaleya National Research Centre for Epidemiology and Microbiology of the Russian Healthcare Ministry. 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.

READ | Pfizer, Moderna, Oxford, Sputnik V: As Covid Vaccines publish results, here's what we know

India to produce over 100 million doses 

Meanwhile, last week on Thursday, November 26, Russia's sovereign wealth fund (RDF) announced that it will produce more than 100 million doses of COVID-19 vaccine Sputnik V annually in India starting 2021 in collaboration with Hetero Biopharma, one of India’s leading generic pharmaceutical companies.

In an official statement, Moscow's sovereign wealth fund said that the Gamaleya Center and RDIF have achieved positive results during the second interim data analysis of the largest double-blind, randomized, placebo-controlled Phase 3 clinical trials of the COVID-19 vaccine. Having confirmed the high efficacy of its experimental candidate, Russia will begin manufacture and distribution as Moscow has received a request for 1.2 billion doses of Sputnik V from more than 50 countries. 

READ | RDIF, Hetero agree to produce over 100 mn doses of Sputnik V vaccine in India

READ | COVID-19: 'Combine AstraZeneca and Sputnik V to boost efficacy', say Russian developers

(With ANI inputs)