The drug regulator may allow the emergency use of Serum Institute of India’s Covishield vaccine in the country without necessarily waiting for the vaccine’s approval in the UK where it was developed, said two senior government officials directly aware of the matter. The Drug Controller General of India may clear the shot for use if clinical data furnished by Serum Institute is found to be satisfactory, the officials cited above said, seeking anonymity. Serum Institute has submitted the additional data as sought by the subject expert committee in the last review (on 9 December) said one of the officials.Covishield is Serum Institute’s version of the vaccine being developed by Oxford University and British drugmaker AstraZeneca Plc. In the December meeting, the expert panel had asked Serum Institute to present the outcome of the assessment of the UK regulator for grant of emergency use licence.This meant that the UK’s approval was thought to be key. The current request submitted by Serum Institute is based on clinical trials data from the UK and Brazil, but the firm is also conducting trials in India, the final results of which are expected to take some more time. “The review here is happening in parallel with the one in the UK. The same data that the UK regulator is reviewing we are also reviewing (along with Serum’s bridging study data), said the person cited above.
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