An expert panel in the Central Drugs Standard Control Organisation (CDSCO) that met on Wednesday to consider emergency use authorisation applications by the SII for the Oxford Covid-19 vaccine and Bharat Biotech's Covaxin will reconvene on January 1 to further deliberate on the matter.
The Subject Expert Committee (SEC) on Covid-19 deliberated and analysed the additional data and information submitted by Serum Institute of India (SII) and Bharat Biotech.
"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 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 authorisation 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.
