SII Seeks Emergency Use Authorisation For Covishield Vaccine

On 6th December, 2020, Pune based Serum Institute of India (SII), 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 India, citing unmet medical needs due to the pandemic and in the interest of the public at large, as per news 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 clearance in the UK and Bahrain.

The phase-three clinical trial of the Oxford COVID-19 vaccine, Covishield, is being conducted by SII, co-sponsored by Indian Council of Medical Research (ICMR), in various parts of the country in addition to clinical studies 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 ICMR, SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI.

As per official sources, SII has stated that data from four clinical studies, two in the UK and one each in Brazil and India, show that Covishield is highly efficacious against symptomatic and most importantly against severe COVID-19 infections. 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, as per the news source. 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.

In order to introduce an urgently needed vaccine against COVID-19 in India, SII, the world’s largest vaccine manufacturer, has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine. The SII has also submitted 12 batches of the vaccine to the Central Drugs Laboratory (CDL) in Kasauli for testing. “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).

According to sources, this vaccine is logistically feasible for distribution in the country’s urban and rural areas, 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.

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