Pune: Serum Institute applies for emergency approval of COVISHIELD vaccine
Pune: Serum Institute of India has sought government consent for emergency approval of the COVID-19 vaccine that it is emerging with the University of Oxford and British drugmaker AstraZeneca.
A day earlier, US pharma giant Pfizer became the first company to seek a similar approval from India’s drug regulator for its own COVID-19 vaccine, after safeguarding clearance in the UK.
“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 its widespread use,” PTI quoted a source as saying, naming the application to the drug regulator.
The phase-three clinical trial of the ‘Covishield’, is being conducted by the Pune-based Serum Institute of India (SII) co-sponsored by Indian Council of Medical Research (ICMR).
It is conducted in various parts of the nation in addition to medicinal studies being carried out by Oxford-AstraZeneca in the UK and Brazil.
Based on phase II and III clinical trial results, the Serum with the help of the ICMR will chase early availability of the vaccine for India, the ICMR had said in November.
According to the apex health research body, the SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and storing license it obtained from the DCGI (Drugs Controller General of India).
Official sources, citing the SII application, said the pharma giant has stated that data from four clinical studies, shows that ‘Covishield’ is highly efficient against symptomatic and most prominently against serious COVID-19 infection.