The Serum Institute of India (SII) has become the first Indian company to seek emergency use authorization for the Oxford vaccine, Covidshield in the country on Sunday. The company has applied at Drugs Controller of India (DGCI) in the large public interest, citing the deficient medical needs due to the coronavirus pandemic, sources told News agency, Press Trust of India.
According to the country's higher medical research body, with the help of the Indian Council of Medical Research (ICMR), SII will be on its way to ensure the early availability of the vaccine in India based on its Phase-2 and 3 trials.
The Pune-based SII that is co-sponsored by the ICMR is conducting phase-3 clinical trials of the Covidshield in multiple parts of India and also studies are being carried out by Oxford-AstraZeneca in the United Kingdom and Brazil.
“In line with our philosophy we assure you that for Covid-19 vaccines also, we are committed to make our country ‘aatmanirbhar’ (self-reliant) and fulfil our prime minister’s clarion call of ‘vocal for local’ and ‘making in India’ for the world,” stated the application signed by Prakash Kumar Singh, Additional Director, Government, and Regulatory Affairs at Serum Institute of India (SII).
The vaccine has the feasibility to be distributed in both Rural and Urban areas of India. It can be stored at a temperature of 2-8 degrees celsius.
In its application, the SII has stated with citation of its data that from four clinical studies (two in the UK and one each in Brazil and India) has shown that Covidshield has high efficacy against symptomatic and even severe infections.
