New Delhi: The Serum Institute of India became the first indigenous company to apply to the DCGI seeking emergency use authorization for the Oxford Covid-19 vaccine in the country citing unmet medical needs due to the pandemic and in the interest of the public at large. According to the official sources 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 own Covid-19 vaccine in the country, after securing such clearance in the UK and Bahrain.

As a rapid regulatory response, the DCGI on August 2 had given nod to SII for conducting the combined phase two and three human clinical trials of the Oxford Covid-19 vaccine in the country.

The phase-three clinical trial of the Oxford COVID-19 vaccine, Covishield, is being conducted by the Pune-based Serum Institute of India on Sunday, co-sponsored by Indian Council of Medical Research, 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.

As per the sources of 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.

According to sources, this vaccine is logistically feasible for distribution in the country’s both urban and rural parts as it can be stored at two to eight degrees Celsius, which is an ideal temperature for being kept in cold storages in the country.