India Considers COVID Vaccine Approval, SEC to Reconvene on 1 Jan

The development came after the UK approved Oxford-AstraZeneca vaccine which SII has partnered to produce for India.

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The Subject Expert Committee of the Central Drug Standard Control Organization (CDSCO) is set to meet on Wednesday, 30 December, to consider the application of the Serum Institute of India’s (SII) for emergency use authorisation of its COVID-19 vaccine.  
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The Subject Expert Committee (SEC) in the Central Drugs Standard Control Organisation (CDSCO) met on Wednesday, 30 December, to consider the Emergency Use Authorisation (EUA) request of Pfizer, Serum Institute of India (SII) and Bharat Biotech Pvt Ltd, following which it was decided that the SEC will convene again on 1 January 2021.

According to a PIB press release, further time was requested by Pfizer and “the additional data and information presented by SII and Bharat Biotech Pvt Ltd was perused and analysed by the SEC.”

BACKGROUND

The development came after the UK became the first country in the world to approve a coronavirus vaccine developed by Oxford University and AstraZeneca, even as it battled the new highly contagious variant of the coronavirus, reported IANS.

According to IANS, earlier this month, the CDSCO had recommended SII to submit the outcome of the assessment of the UK-MHRA for the grant of EUA, updated safety data of the Phase II/III clinical trial and immunogenicity data from the clinical trial in the UK and India to secure the approval.

The central government plans to vaccinate nearly 30 crore people in the first phase of the drive. It will be offered to one crore healthcare workers, along with 2 crore frontline and essential workers and 27 crore elderly, mostly above the age of 50 years with co-morbidities.

India currently has eight COVID-19 vaccine candidates, including three indigenous vaccines, under different stages of clinical trials which could be ready for authorisation in the near future, reported IANS.

(With inputs from IANS.)

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