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 Drugs Controller General of India (DCGI) seeking emergency use authorisation for Oxford COVID-19 vaccine Covidshield in country. Taking to Twitter, SII's Chief Executive Officer ar Poonawalla informed that 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.

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

RE | Serum Institute To Seek Emergency Authorization Of Covishield From DCGI In Next 2 Weeks

'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 (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.

RE | Serum Institute Seeks Emergency Use d For Covid-19 Vaccine In India, Second After Pfizer

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 is obtained from DCGI.

"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.

RE | ar Poonawalla Puts $250 Million On COVID Vaccine 'gamble', Reveals What His Far Said

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. 

RE | Serum CEO ar Poonawalla 'delighted' As Oxford's COVID-19 Vaccine Shows Over 70% Efficacy