SII's Adar Poonawalla confirms COVISHIELD vaccine emergency use application; thanks PM

After American pharma giant Pfizer, Serum Institute of India (SII) on Sunday applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for the Oxford COVID-19 vaccine Covidshield in the country. Taking to Twitter, SII's Chief Executive Officer Adar Poonawalla informed that the company has applied for emergency use authorization for Covidshield. Stating that this vaccine will save many lives, SII's CEO also thanked Prime Minister Narendra Modi.

The SII is the first indigenous company that has sought emergency approval for the vaccine developed along with global pharma giant AstraZeneca and Oxford University.

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'Covishield is safe and well-tolerated'

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. The phase-three clinical trial of the Oxford COVID-19 vaccine, Covishield, is being conducted by the Pune-based Serum Institute of India (SII), 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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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. According to the ICMR, the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license is obtained from the DCGI.

"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.

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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. 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 is learnt to have said. 

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