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SEC to reconvene on Jan 1 to consider emergency use authorisation for Covid-19 Vaccines

SEC to reconvene on January 1 to consider emergency use authorisation for COVID-19 vaccines
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Synopsis
The subject expert committee on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) on December 9 had sought additional safety and efficacy data for Covid-19 vaccines of SII and Bharat Biotech after deliberating upon their applications.
The approval is a big boost to Serum Institute, which is among the top three vaccine makers in the race to help India inoculate its massive population.
NEW DELHI: The Subject Expert Committee (SEC) of the Indian drug regulator has sought additional information from Serum Institute of India (SII) and Bharat Biotech while not clearing their Covid-19 vaccine market approval applications on Wednesday. The next meeting of the panel will be held on Friday.

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No recommendation for emergency approval in India yet, SEC seeks more data from Bharat Biotech, SII

No recommendation for emergency approval in India yet, SEC seeks more data from Bharat Biotech, SII
India
Published: Wednesday, December 30, 2020, 21:49 [IST]
New Delhi, Dec 30: The Subject Expert Committee (SEC) in Central Drugs Standard Control Organisation (CDSCO) that met on Wednesday did 'not consider' the emergency approval of COVID-19 vaccines from Pfizer, Serum Institute of India (SII) and Bharat Biotech Pvt Limited.
According to the report, the SEC said that the vaccine will not be given authorisation "yet" as more data is needed.
"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 SEC. The analysis of the additional data and information is going on. SEC will convene again on January 1," the expert panel said in a statement

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