The Central Drugs Standard Control Organisation (CDSCO) panel on Saturday, 2 January, recommended granting approval for restricted emergency use of Bharat Biotech's indigenous COVID vaccine ‘Covaxin’ in India, PTI reported quoting government sources.
This is the second vaccine to get approval from experts. The Subject Expert Committee (SEC) set up by the Drugs Controller General of India (DCGI) has reportedly been reviewing Covaxin’s application for emergency use.
A government press note said that the CDSCO recommended for granting permission to Bharat Biotech for “restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, especially in context of mutant strain infection.”
Earlier, on Friday, the SEC had sought more information from Bharat Biotech regarding its vaccine, maintaining that the data provided was insufficient for an emergency approval.
The expert panel had met again on Saturday to take a call on the emergency use of Bharat Biotech, Serum Institute and Pfizer’s vaccine candidates in India.
The Oxford-AstraZeneca COVID-19 vaccine, which is called Covishield in India, also received recommendation for emergency use “subject to multiple regulatory conditions” in the country.
However, both the vaccines are yet to receive a formal clearance from the DCGI.
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