Serum Institute of India that is manufacturing the AstraZeneca coronavirus vaccine is likely to get approval for emergency use soon after the UK drug regulator gives the green signal to Covishield. Officials expect the approval to come before Christmas.
The Medicines and Healthcare Products Regulatory Agency is currently evaluating the best dosage regimen for the AstraZeneca-Oxford vaccine, as mentioned in a report in Times of India. The MHRA approval is likely to come before Christmas and regulatory sources told the daily that India might give the nod soon after that.
An official said 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," said the official, as mentioned in the daily.
The MHRA's evaluation is likely to bring more clarity on dosage of the COVID-19 vaccine. It has shown efficacy of 62 per cent when two full doses are given to trial participants, and 90 per cent efficacy for a smaller sub-group who were given a half dose and then a full dose.
Additionally, the Subject Expert Committee (SEC), a government panel tasked with vetting coronavirus vaccines has asked Serum Institute to submit updated safety data of its Phase 2 and 3 human clinical trials in the country along with immunogenicity data from the trial in the UK and India. The panel said that since the coronavirus vaccine is under evaluation with the UK drug regulator, Serum Institute must furnish details regarding the outcome of the assessment by MHRA for the emergency use authorisation approval.