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SEC recommends regular market authorisation for Covishield and Covaxin: Sources

SEC recommends regular market authorisation for Covishield and Covaxin: Sources

SEC recommends regular market authorisation for Covishield and Covaxin: Sources
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By CNBCTV18.com Jan 19, 2022 10:57:54 PM IST (Updated)

Subject Expert Committee on Friday recommended regular market authorisation to Covishield and Covaxin. SII had applied for market approval for the Covishield vaccine in December 2021 and Bharat Biotech also applied for the same a few days ago.

Drugs Controller General of India (DCGI)'s Subject Expert Committee on Friday recommended regular market authorisation for Covishield and Covaxin, official sources said.

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Both the vaccines will be available at clinics and hospitals registered with CoWin, sources added.
The recommendations will be sent to DCGI for final approval. During last week's meeting the SEC had sought more data and information from the two companies.
Serum Institute of India (SII) had applied for market approval for the Covishield vaccine in December 2021 and Bharat Biotech also applied for the same a few days ago.
Both Covaxin and Covishield are currently authorized for emergency use only. EUA does not represent approval of a vaccine in the full statutory term but authorises the use of an unapproved product or unapproved use of an approved product in a declared state of emergency such as a pandemic.
A market authorisation label for a vaccine means it can be authorised for use without reservations or conditions.
 
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