The vaccine, developed by the Serum Institute of India with Oxford and AstraZeneca, is the first candidate that’s being tested in India to seek emergency approval.
New Delhi/Pune: The Serum Institute of India (SII) has applied for emergency use authorisation for the Oxford-AstraZeneca COVID-19 vaccine on December 6.
Serum Institute of India, the world’s largest vaccine maker by the number of doses produced, is the very first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking authorisation for coronavirus vaccine in the country.
This comes a day after the Indian arm of US pharmaceutical giant Pfizer sought a similar approval from India’s drug regulator to use its Covid-19 vaccine candidate in India.
Official sources 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 phase-three clinical trial of Covishield, co-sponsored by Indian Council of Medical Research (ICMR), is being conducted in various parts of the country in addition to clinical studies being carried out by Oxford-AstraZeneca in the UK and Brazil.
The company had also said that the vaccine showed 90 per cent efficacy in one dosing regimen when the vaccine was given as a half dose, followed by a full dose at least a month later, while another dosing regimen showed 62 per cent efficacy when given as two full doses at least one month apart. The vaccine can be stored in 2 Celsius to 8 Celsius, unlike Pfizer’s vaccine that needs to be stored and transported at -70 degrees.