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Market clearance for Covishield and Covaxin is recommended by an expert panel.

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Peeyush Ghalot
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The Covid-19 vaccine expert panel recommended to the regulator, the Central Drugs Standard Control Organization (CDSCO), that the Serum Institute of India's Covishield and Bharat Biotech's Covaxin be granted full market authorization with conditions for the adult population. The suggestions will be considered, and a decision will be made. Covishield and Covaxin have been available under Emergency Use Authorization since January of last year (EUA). The EUA route, known in India as restricted use in emergencies, is used in public health emergencies such as pandemics. Based on preliminary data from phase 3 clinical trials, the regulator determines that the vaccine's potential benefits outweigh its potential risks when used to prevent Covid-19.

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The CDSCO subject expert committee has upgraded Covishield and Covaxin's status from restricted use in emergency settings to new drug approval with conditions in the adult population. DCGI will consider the suggestions and make a decision. As of Wednesday, the country had received 137 crore doses of Covishield and 21.75 crore doses of Covaxin. Currently, the two vaccinations can only be given as part of the government's vaccination campaign, and the government keeps track of all the vials produced. These vaccinations cannot be sold in the retail market under the current EUA conditions.

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