SunstarTV Bureau: The India government on Monday approved Sputnik V, the vaccine against the Corona virus developed by Russia. The approval comes after acute vaccine shortages that have states writing to the Central government as stocks run low.
The Subject Expert Committee (SEC) advising the Drug Controller General of India (DCGI) has recommended Russia’s Sputnik V for emergency use authorisation in India. Dr Reddy’s spokesperson confirmed the development.
Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of phase 3 clinical trial, which included data on 19,866 volunteers in Russia.
Notably, the development comes as India is reeling under the second wave of coronavirus, and many states are in the midst of an acute vaccine shortage. India is currently using Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin.
India’s Covid surge has raised an alarm as the country reported over 1 lakh cases for the sixth straight day on Monday. India is now the second worst-hit nation, surpassing Brazil.
In its last meeting on April 1, the Subject Expert Committee of CDSC O sought more data on Sputnik’s clinical trial in India conducted by Dr Reddy’s Laboratories. The data was sought on six specific points including “unblinded data of all Serious Adverse Events and RT-PCR Covid-19 positive cases along with causality analysis reported till date for further examination”.
