Covid-19 vaccine Photograph:( Reuters )
The phase-three clinical trial of the vaccine, named as Covishield in India, is being carried out by SII in various parts of the country
The Serum Institute of India (SII) applied to the Drugs Controller General of India (DCGI) on Sunday for granting emergency use authorisation for the Oxford-AstraZeneca coronavirus vaccine.
The CEO and owner of the institute confirmed the news via a tweet and thanked the Indian Prime Minister Narendra Modi and government for their "invaluable support".
As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support.— Adar Poonawalla (@adarpoonawalla) December 7, 2020
The phase-three clinical trial of the vaccine, named as Covishield in India, is being carried out by SII in various parts of the country.
The official sources told news agency PTI, SII's application mentioned data from four clinical studies, two in the UK and one each in Brazil and India, and said that Covishield is highly efficacious against symptomatic and most importantly against severe Covid-19 cases.
"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," said a source.
"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."
For a quick roll out of the vaccine, SII, world's largest vaccine manufacturer, entered into a collaboration with the University of Oxford and AstraZeneca to produce the drug and has already produced 40 million doses of the drug.