Chennai: The Serum Institute of India (SII) on Sunday became the first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for the Oxford Covid-19 vaccine in the country.
Sources said, the approval was sought citing unmet medical needs due to the pandemic and in the interest of the public at large.
A day earlier, the Indian arm of Pfizer, became the first to seek a similar clearance from India’s drug regulator for its own Covid-19 vaccine in the country, after securing such clearance in the UK and Bahrain. The phase-3 clinical trial of the Oxford Covid-19 vaccine, Covishield, is being conducted by the Pune-based 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 2 and 3 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 efficacious against symptomatic and most importantly against severe Covid-19 infections.