Covid-19: Serum Institute of India may get emergency use approval for Covishield soon | News – Times of India Videos


Dec 11, 2020, 08:26AM ISTSource: TOI.in

Serum Institute of India may get emergency use approval for Covishield in India soon after the UK’s drug regulator MHRA gives a nod to the vaccine, which officials here expect to be before Christmas. The Medicines and Healthcare Products Regulatory Agency is currently evaluating data including which dosing regimen is best to use for the Covid vaccine developed by UK’s Oxford and AstraZeneca. Regulatory sources said the MHRA approval is expected before Christmas and India may give a go-ahead soon after that. “The regulatory approval in the UK is crucial to strengthen Serum Institute of India’s application seeking emergency use authorisation in India because the proposal here refers to trials being conducted in the UK and Brazil. Moreover, the vaccine is yet to be approved in any country. It is a sensitive matter and only once we are sure of the safety, efficacy and immunogenicity of the vaccine, we can grant an approval,” an official said.

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