Two days after Pfizer sought approval from the from Drug Controller General of India (DCGI), Pune-based Serum Institute of India (SII) on Sunday, has asked for government's approval for emergency use authorisation (EUA) of its coronavirus vaccine 'Covishield'.
With this, the pharma firm has become the first indigenous company to apply for the EUA to the DCGI, news agency Outlook quoted official sources. The firm is manufacturing the vaccine in association with the University of Oxford and British drugmaker AstraZeneca.
Earlier, on August 2, the DCGI had approved the firm for conducting Phase 2 and 3 human trials of its vaccine.
The Phase- 3 trial of Covishield is being conducted by SII in various parts of the country, in addition to the clinical studies being carried out by Oxford-AstraZeneca in the United Kingdom and Brazil.
In its application submitted to DCGI, the firm has stated that data from four clinical studies, two in the UK and one each in Brazil and India, shows Covishield's high efficiency against the symptomatic cases and severe COVID-19 infections.
"In terms of safety, Covishield was well tolerated concerning 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. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield," the application further read.
Currently, the SII has submitted 12 batches of the vaccine to the Central Drugs Laboratory (CDL) in Kasauli for testing.
The pharma company states it is committed to making India' Atma-nirbhar' and fulfilling our prime minister's clarion call of 'vocal for local' and make in India' for the world.'
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