Sputnik V vaccine approved in India
Russia's COVID-19 vaccine Sputnik V has been recommended for use in India by a committee of experts as the country battles a record spike in virus cases in the country.
If approved by regulator DCGI, this 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.
After the Subject Expert Committee (SEC)'s recommendation, the vaccine has to be greenlit by the Drug Controller General of India before it can be widely used to inoculate citizens. Sputnik V is on track for clearance amid complaints of vaccine shortage from many states, especially Maharashtra, the epicenter of the second surge.
In its last meeting on April 1, the experts' 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 unblinded data of all the serious adverse events; "unblended" means when subjects know whether the shot administered to them was 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.
In India, Sputnik V trials are on for around 1,600 people between 18 and 99, NDTV reported.