Sec seeks more data to grant full market approval to Covishield and Covaxin: sources

On Friday, the subject matter expert committee of the Drugs Controller General of India (DCGI) requested more data from Bharat Biotech and the Serum Institute of India (SII) before granting full marketing approval. market to Covaxin and Covishield, sources said.

Sources added that SII and Bharat Biotech cannot be allowed to sell Covaxin and Covishield on the open market until the government maps vaccination through a specific national campaign through the Cowin app.

SII had filed a marketing authorization application for the Covishield vaccine in December 2021 and Bharat Biotech also filed an application 10 days ago.

However, Covaxin and Covishield are currently licensed for emergency use only. The EUA does not represent approval of a vaccine in its entirety, but authorizes the use of an unapproved product or the unapproved use of an approved product in a declared state of emergency such as a pandemic. A marketing authorization label for a vaccine means that its use can be authorized without reservations or conditions.

(Edited by : Aditi Gautam)

First publication: STI


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