The Serum Institute of India (SII) has applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation (EUA) for the Oxford Covid-19 vaccine in the country. With this, SII would become the first indigenous company to apply for the same.
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, a PTI report said.
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 report said. 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.
“In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with an increased number of SAEs and deaths. A majority of solicited reactions were mild in severity and resolved without any sequelae. Therefore, Covishield is safe and well-tolerated and can be used effectively for prevention of Covid-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield,” a source said quoting the application.
The SII has also submitted 12 batches of the vaccine to the Central Drugs Laboratory (CDL) in Kasauli for testing, a source said. “In line with our philosophy we assure you that for Covid-19 vaccines also, we are committed to making our country ‘aatmanirbhar’ (self-reliant) and fulfilling our prime minister’s clarion call of ‘vocal for local’ and ‘making in India’ for the world,” the application signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs at Serum Institute of India (SII), was quoted saying.
In view of all these facts and unmet medical needs in the interest of the public at large to save millions of people in the country and across the globe, early availability of a vaccine against Covid-19 is a necessity, the application further stated. “So, in the national interest, we request you to grant us emergency use authorisation of Covishield based on our application and in view of immediate need for a safe, effective, programmatically suitable and affordable vaccine for our country,” the application read.