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Review panel asks vaccine makers to submit more data to get authorisation

Experts ask Bharat Biotech for phase 3 data, Serum's UK approval status

Coronavirus, vaccine, covid, drugs, clinical trials
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The decision of the expert committee would be considered final as the DCGI is unlikely to take a contrarian call, according to sources.

Sohini Das Mumbai
The wait for the Covid-19 vaccine just got a bit longer for India as two key players were told on Wednesday that their clinical trial data was inadequate for a fast-track approval. At a virtual review meeting, spread through the day, the subject expert committee (SEC) asked vaccine makers Bharat Biotech International (BBIL) and Serum Institute of India (SII) to come back with more data for getting an accelerated marketing authorisation.      

The expert committee, which is advising the Drug Controller General of India (DCGI) on the matter, flagged several concerns such as why the AstraZeneca vaccine, with which