The Centre on Monday approved Russia’s Sputnik V COVID-19 vaccine on Monday and recommended it for use amid a surge in cases in the country. A committee of experts has recommended to use Sputnik V for use and if approved by the regulator DCGI, this will be the third vaccine after Serum Institute of India’s Covishield 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.
According to a NDTV report, 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. In its last meeting on 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 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.
The vaccine is also in trials in the UAE, Venezuela and Belarus.
The dry form of the vaccine can be stored at 2 to 8 degrees, the report stated.
Government officials have reportedly said five more vaccines will be in use in India by October.