A day after Pfizer India sought the nod of the drug regulator to import and market its COVID-19 vaccine in India, the Serum Institute of India (SII) on Sunday (December 6) applied to the Drugs Controller General of India (DGCI) for the emergency use authorisation (EUA) of the Oxford vaccine in India.
An official citing the application of SII told Indian Express that the vaccine Covishield has been proved highly efficient against symptomatic and severe COVID-19 infections during four clinical studies – two in the UK and one in Brazil and India each.
Vouching for the vaccine’s efficacy in alleviating the mortality and morbidity of the disease, the company has reportedly mentioned in the application that the results of the clinical trials are also in line with the findings from trials of other COVID-19 vaccines.
“In terms of safety, Covishield was well tolerated with respect to solicited adverse events and was not associated with an increased number of severe adverse events and deaths. 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,” IE quoted a source as saying.
The report said the DGCI has referred Pfizer’s EUA application before a panel of experts which will study the data of its clinical trials conducted abroad and give its verdict.
The regulatory process of emergency authorization approvals for both the Pfizer vaccine and Covishield may take place in the next few days, government officials told IE.