NEW DELHI: Serum Institute of India (SII) may gain emergency use approval for Covishield in India shortly after UK drug regulator MHRA gives the go-ahead to the vaccine, which officials here hope will be before Christmas.
The Medicines and Healthcare Products Regulatory Agency (MHRA) is evaluating data including which dosage regimen is best to use for the Covid vaccine developed by Oxford and AstraZeneca in the UK. Regulatory sources said MHRA approval is expected before Christmas and India could give the green light soon after.
“Regulatory approval in the UK is crucial to strengthen the SII application seeking emergency use authorization in India because the proposal here refers to trials that are being carried out in the UK and Brazil. Also, the vaccine has not yet been approved in any country. It is a sensitive issue and only once we are sure of the safety, efficacy and immunogenicity of the vaccine, can we grant approval, “said an official.
In addition, evaluation of the MHRA data is likely to provide more clarity on the dose of the vaccine, which has shown an efficacy of 62% when two full doses were administered to trial participants, but 90% for a subgroup. smallest who received a half dose and then a full dose.
During an inter-ministerial meeting on vaccination in South Asia organized by the World Bank, Health Minister Harsh Vardhan said: “The vaccine is expected to be available in the next few weeks and the vaccination process will start in India as soon as it is approved. by the corresponding regulatory agency ”.
The Medicines and Healthcare Products Regulatory Agency (MHRA) is evaluating data including which dosage regimen is best to use for the Covid vaccine developed by Oxford and AstraZeneca in the UK. Regulatory sources said MHRA approval is expected before Christmas and India could give the green light soon after.
“Regulatory approval in the UK is crucial to strengthen the SII application seeking emergency use authorization in India because the proposal here refers to trials that are being carried out in the UK and Brazil. Also, the vaccine has not yet been approved in any country. It is a sensitive issue and only once we are sure of the safety, efficacy and immunogenicity of the vaccine, can we grant approval, “said an official.
In addition, evaluation of the MHRA data is likely to provide more clarity on the dose of the vaccine, which has shown an efficacy of 62% when two full doses were administered to trial participants, but 90% for a subgroup. smallest who received a half dose and then a full dose.
During an inter-ministerial meeting on vaccination in South Asia organized by the World Bank, Health Minister Harsh Vardhan said: “The vaccine is expected to be available in the next few weeks and the vaccination process will start in India as soon as it is approved. by the corresponding regulatory agency ”.
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