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Conditional Approval for Serum, Bharat Bio COVID-19 Vaccines In India Amid Uproar

Confusion Over Serum's Exports Of AZ Vaccine

 
• By Vibha Ravi

India gave a conditional accelerated approval to AstraZeneca partner Serum Institute and separately, to Bharat Biotech for their COVID-19 vaccines. With the latter’s vaccine still in Phase III trials, the unprecedented decision caused a flutter as the regulator had earlier said an EUA would not be granted unless trials are completed.

Close-up Of A Businessperson's Hand Stamping On Approved Contract Form
Conditional Nod For Two COVID-19 Vaccines In India • Source: Shutterstock

In a move indicative of the unusual times that the world finds itself in due to COVID-19, India granted conditional accelerated approvals to two vaccines, one for which Phase III clinical trials recruitment is still not complete and the other which seemingly lacks efficacy data from Indian studies.

Both Serum Institute of India Pvt. Ltd. and Bharat Biotech, whose vaccines got approved on 3 January for...

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