Bharat Biotech’s Covaxin approved for restricted emergency use by expert panel

NEW DELHI: Covaxin, the Covid-19 vaccine, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology became the second vaccine in India to inch one step closer to the final approval for emergency use.

The subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Saturday recommended Covaxin for restricted emergency use.

The vaccine candidate from Pune-based Serum Institute of India (SII) -- COVISHIED -- has earned the stamp of approval of a Subject Expert Committee (SEC) of the Drug Controller General of India (DGCI). The SII has said that 100 million doses will be available within the first week of January.

According to reports, the Hyderabad-based Bharat Biotech, which has developed another candidate called “Covaxin”, was asked to furnish more data demonstrating the efficacy of its candidate.

The nod for “Covishield” came at the end of a marathon meeting of the SEC which went on till late in the evening.

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The SEC gives its recommendation to the DGCI, which is the approving authority for drugs and vaccines.

This is the second time in three days that the SEC met to review applications for emergency use approval by SII, BB and Pfizer India, which are all developing vaccine candidates to fight the corona.

The Pfizer India has sought more time, but the company’s m-RNA vaccine has already been approved, under emergency use conditions, in the United States, United Kingdom and pre-qualified by the World Health Organisation.

According to reports, the “Covishield” is likely to be available for use within the next week. The vaccine has to be given in two doses 4-12 weeks apart.

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