Pfizer, SII, Bharat Biotech seek emergency use authorization for COVID vaccines: CDSCO panel to reconvene on Jan 1

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 with 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 Hyderabad-based 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 authorization for Covishield on December 6 while the Hyderabad-based Bharat Biotech had sought a similar nod for its indigenously developed Covaxin on December 7.

Pfizer had applied for a similar approval for its vaccine on December 4.

Also Read:Oxford COVID-19 vaccine roll out in UK to start from 4 January: Sunday Telegraph report