New Delhi: Russia’s COVID-19 vaccine Sputnik-V has been cleared for emergency use approval in India by a committee of experts. The clearance to use Sputnik-V has come in the middle of a record spike in virus cases in India. After the expert panel clearance, Sputnik-V needs to be approved by regulator DGCI. If that happens it will be the third vaccine to be used in India after Serum Institute of India’s Covishield – developed by Oxford-AstraZeneca and Bharat Biotech’s Covaxin.
Sputnik-V is being manufactured in India by Dr Reddy’s. Sources nd clinical trials have proved that it has the highest effectiveness – 91.66 per cent. It is third only to the efficacy of the Moderna and Pfizer shots.
The Subject Expert Committee (SEC) of the Indian drug regulator met to clear the vaccine for emergency use approval in its last meeting April 1. The committee had asked Dr Reddy’s to submit data on how the shot activates the body’s immune response against the coronavirus.
The panel had also asked for data of all the serious adverse events – meaning that subjects would know which shot was administered to them, the vaccine or a placebo. A comparative analysis of phase III data generated on the Indian and Russian studies at various times was also sought.
Dr Reddy’s had applied February 19 for emergency use of Sputnik-V, which is in Phase 3 of clinical trials in India, the UAE, Venezuela and Belarus. In India, Sputnik-V trials are on for around 1,600 people between 18 and 99.