CDSCO to consider emergency use authorisation request of Pfizer, Serum, Bharat Biotech on Jan 1

The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) met on Wednesday to deliberate upon the emergency use authorisations of the Oxford-Astrazeneca vaccine, as applied by the Serum Institute of India (SII). The committee also considered the applications of Bharat Biotwech's 'Covaxin,' and is to reconvene on January 1 for further discussions.  

"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," PTI quoted the Health Ministry as saying.  

The expert committee on COVID-19 analysed the additional data and information that it had asked from SII and Bharat Biotech earlier this month.  

The committee had recommended SII on December 09 to submit updated data on safety from phase 2 and 3 of the clinical trials in India, the immunogenicity data from the clinical trials in the UK and India, as well as the assessment of the UK's Medicines and Healthcare products Regulatory Agency (MHRA) of the emergency use authorisation (EUA). 

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As for Hyderabad-based Bharat Biotech, the committee had asked the firm to present safety and efficacy data from the then-ongoing phase 3 of the clinical trials.  

"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," the statement added.

The vaccine developed by the University of Oxford in collaboration with AstraZeneca was approved on Wednesday by the UK's MHRA. Pune-based SII happens to be the world''s largest manufacturer of vaccines, and is producing the said vaccines named 'Covishield.'

SII had applied for Covishield's EUA to the Drugs Controller General of India (DCGI) on December 6, with Bharat Biotech seeking the nod for the indigenous vaccine on December 07.

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