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SEC to consider emergency use authorisation request of Serum, Bharat Biotech on January 1

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The Subject Expert Committee (SEC) of the Indian drug regulator is considering Emergency Use Authorisation (EUA) requests from Serum Institute of India (SII) and Bharat Biotech's application for COVID-19 vaccines.

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) is considering EUA requests from Serum Institute of India (SII) and Bharat Biotech's application for COVID-19 vaccines when it will reconvene on January 1, 2010, reported CNN-News18.
Coming to Pfizer India, the company will make a presentation before SEC of CDSCO for approval of its COVID-19 vaccine. An emergency use authorisation (EUA) is short of a full approval.
This comes in after SEC on COVID-19 deliberated and analysed the additional data and information submitted by SII and Bharat Biotech yesterday. "The Subject Expert Committee (SEC) in the CDSCO met today in the afternoon to consider the emergency use authorisation (EUA) request of Pfizer, Serum Institute of India (SII) and Bharat Biotech Pvt. Ltd," the health ministry said in a statement.
"Further time was requested on behalf of Pfizer. The additional data and information presented by SII and Bharat Biotech Pvt. Ltd was perused and analysed by the SEC. The analysis of the additional data and information is going on. The SEC will convene again on January 1, 2021," it said.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday approved the COVID-19 vaccine developed by scientists at Oxford University and produced by AstraZeneca for human use. The Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer, has entered into a tie-up AstraZeneca to manufacture 'Covishield'.
While considering SII's application, the SEC on December 9 had recommended that the firm should submit updated safety data of phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK MHRA for grant of EUA.
As for Bharat Biotech, after detailed deliberation, the committee had recommended that the firm should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration.
SII had applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for Covishield on December 6 while Bharat Biotech had sought a similar nod for its its indigenously developed Covaxin on December 7. Pfizer had applied for a similar approval for its vaccine on December 4.
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