NEW DELHI: Serum Institute of India (SII) 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 (MHRA) 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 SII’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.
Also, the MHRA’s evaluation of data is likely to bring more clarity on dosage of the vaccine — which has shown efficacy of 62% when two full doses were given to trial participants, but 90% for a smaller sub-group given a half dose and then a full dose.
During an inter-ministerial meeting on vaccination of South Asia organised by the World Bank, health minister Harsh Vardhan said, “It is expected that the vaccine will be available in the coming few weeks and vaccination process will kick-start in India as soon as it is approved by the regulatory agency concerned.”\
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