India may approve Russia's Sputnik V vaccine for COVID-19 in the next few weeks, says India's Ambassador to Moscow. The vaccine is currently undergoing Phase 3 trials in India. Dr Reddy's Laboratories had collaborated with the Russian Direct Investment Fund (RDIF) in September 2020 to conduct clinical trials of Sputnik V as well as for its distribution.
Upon regulatory approval in India, RDIF shall supply 100 million doses of the vaccine, developed by the Gamaleya Research Institute and the Russian defence ministry, to Dr Reddy's.
Earlier, Dr Reddy's had said it expects to roll out Sputnik V vaccine in India in March via Emergency Use Authorisation (EUA) after the completion of Phase 3 trials. The company had said it expects Phase 3 trials to end by February.
As per the interim analysis of phase 3 trials, conducted in Moscow, published in medical journal the Lancet, the two-dose vaccine showed 91.6 per cent efficacy in the trials with no serious side effects. Sputnik V was well tolerated in a large cohort, it said.
The Gam-COVID-Vac, called Sputnik V, is a two-part vaccine that includes two adenovirus vectors - recombinant human adenovirus type 26 (rAd26-S) and recombinant human adenovirus type 5 (rAd5-S). The vaccine was approved in Russia even before the release of Phase 3 trials data.