The Serum Institute of India (SII) became the first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking emergency use authorisation (EUA) for the Oxford Covid-19 vaccine in the country, reports quoting official sources said.
A day earlier, the Indian arm of US pharmaceutical giant Pfizer became the first to seek a similar approval from India’s drug regulator for its Covid-19 vaccine in the country, after securing similar clearances in the UK and Bahrain.
The phase-three clinical trial of the Oxford Covid-19 vaccine–Covishield, is being conducted by the Pune-based Serum Institute of India (SII), co-sponsored by the Indian Council of Medical Research (ICMR), in various parts of the country in addition to clinical studies being carried out by Oxford-AstraZeneca in the UK and Brazil.
Based on phase two and three clinical trial results, the SII with the help of the ICMR will pursue early availability of the vaccine for India, the country’s apex health research body had said last month. According to the ICMR, the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI.
Official sources, citing the SII application said, the firm has stated that data from four clinical studies, two in the UK and one each in Brazil and India, shows that Covishield is highly effective against symptomatic and most importantly against severe Covid-19 infections.
The results are in line with other coronavirus vaccines and because of the huge disease burden, Covishield is predicted to alleviate substantial Covid-19 mortality and morbidity, the firm is learnt to have said.
