11.3.21

‘Clinical trial’ tag to be removed from Covaxin

In a move likely to boost the use of Bharat Biotech’s anti-Covid vaccine Covaxin, the drug regulator's subject expert committee on Wednesday recommended doing away with the “clinical trial mode” for its use and making it a case of regular emergency use authorisation.

Omission of the condition means the vaccine can be administered without an informed consent from the recipient and also removal of compensation provision in case of adverse event under the clinical trial protocol.

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