Serum Institute seeks emergency use nod for Covid-19 vaccine in India, second after Pfizer

Serum Institute of India on Sunday became first indigeus company to apply to Drugs Controller General of India (DCGI) seeking emergency use authorisation for Oxford COVID-19 vaccine in country. vaccine manufacturer cited unmet medical needs due to pandemic and interest of public at large, news ncy PTI quoted official sources as saying.

'Covishield is safe and well-tolerated'

A day earlier, Indian arm of US pharmaceutical giant Pfizer became first to seek a similar approval from India's drug regulator for its own COVID-19 vaccine in country, after securing such clearance in UK and Bahrain.

phase-three clinical trial of Oxford COVID-19 vaccine, Covishield, is being conducted by Pune-based Serum Institute of India on Sunday (SII), co-sponsored by Indian Council of Medical Research (ICMR), in various parts of country in dition to clinical studies being carried out by Oxford-AstraZeneca in UK and Brazil.

Based on phase two and three clinical trial results, SII with help of ICMR will pursue early availability of vaccine for India, country's apex health research body h said last month. According to ICMR, SII has alrey manufactured 40 million doses of vaccine under at-risk manufacturing and stockpiling license it obtained from DCGI.

Official sources, citing SII application, said firm has stated that data from four clinical studies, two in UK and one each in Brazil and India, shows that Covishield is highly efficacious against symptomatic and most importantly against severe COVID-19 infections.

results are in line with or anti-Coronavirus vaccines and because of huge disease burden, Covishield is predicted to alleviate substantial COVID-19 mortality and morbidity, firm is learnt to have said.

"In terms of safety, Covishield was well tolerated with respect to solicited verse events and was t associated with an increased number of SAEs and deaths. A majority of solicited reactions were mild in severity and resolved without any sequelae. refore, Covishield is safe and well-tolerated and can be used effectively for prevention of COVID-19 in targeted population. Thus, benefit to risk ratio strongly supports widespre use of Covishield," a source said quoting application.

'Committed to make India aatmanirbhar'

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

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"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 world," stated application signed by Prakash Kumar Singh, ditional Director, Government and Regulatory Affairs at Serum Institute of India (SII).

"So, in 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," application re.

This vaccine is logistically feasible for distribution in 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 stors in country.

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