Russia’s Sputnik-V Vaccine Cleared For Emergency Use By Expert Govt Committee
Mumbai: An expert government committee on Monday recommended Russia’s Sputnik-V COVID-19 vaccine for emergency use in India. If approved by DCGI, this will be the third COVID-19 vaccine to get emergency use approval, after Covishield and Covaxin.
Sputnik V manufactured in India by Dr Reddy’s has the highest effectiveness – 91.6 per cent – followed by Modern and Pfizer shots. Dr Reddy applied for emergency use of the vaccine on 19 February, which is in Phase 3 of a clinical trial in India.
Following the recommendation of the Subject Expert Committee (SEC), the vaccine should be greenlighted by the Drug Controller General of India, as it can be widely used to vaccinate citizens. Sputnik V is among many states complaining of vaccine deficiency, most notably Maharashtra, the second development epicentre.
At its last meeting on 1 April, Dr Reddy was asked by the Committee of Experts to submit data on how the shot activates the body’s immune response against coronavirus.
The panel also stated ambiguous data of all serious adverse events; “Unclear” means when subjects discover whether the vaccine given to them was a 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 two-dose vaccine, developed by Russia’s Gamalaya 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.
This approval was recorded in 24 hours in 1,68,912 new COVID cases in India, the sixth record increase in seven days, surpassing the country’s caseload over 1.35 crore.
Government officials have reportedly said five more vaccines will be in use in India by October.
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