India Grants Controversial Conditional Approvals To Serum, Bharat COVID-19 Vaccines

Confusion Over Serum's Exports Of AZ Vaccine

India has given conditional accelerated approval to AstraZeneca partner Serum Institute, and separately to Bharat Biotech, for their COVID-19 vaccines. With the latter’s candidate still in Phase III trials, the unprecedented decision has caused controversy given the national 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 Nods For Two COVID-19 Vaccines In India • Source: Shutterstock

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

Both Serum Institute of India Pvt. Ltd

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