The Serum Institute of India (SII) has applied for emergency use authorisation for the Oxford-AstraZeneca COVID-19 vaccine on December 6. SII is the first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking authorisation for coronavirus 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, co-sponsored by 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.
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SII has stated that data from four clinical studies, two in the UK and one each in Brazil and India, to show that Covishield is highly efficacious against symptomatic and most importantly against severe COVID-19 infections.
The results are in line with other anti-coronavirus vaccines and because of the huge disease burden, Covishield is predicted to alleviate substantial COVID-19 mortality and morbidity, the firm told DGCI.
Read: Pfizer COVID Vaccine Ready For Use In UK: What Is India's Plan On Vaccination?
"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 told news agency PTI, quoting the application.
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.
Read: How India’S Ecosystem Is Gearing Up For A Smooth Rollout Of COVID-19 Vaccines
"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).
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.
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