Russia’s Covid 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.
Sputnik V, manufactured in India by Dr Reddy’s, has the highest effectiveness – 91.6 per cent — after the Moderna and Pfizer shots. Dr Reddy’s had applied on February 19 for emergency use of the vaccine, which is in Phase 3 of clinical trials in India.
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; “unblinded” 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.
The vaccine is also in trials in the UAE, Venezuela and Belarus.
Sputnik V, named after the first Soviet Space satellite, works on the principle of a weakened Covid virus delivering parts of a pathogen that triggers an immune response in the body.
The two-dose vaccine, developed by Russia’s Gamaleya Institute, costs less than $10 for each shot in international markets.
The dry form of the vaccine can be stored at 2 to 8 degrees.
