An expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Dec 9 sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute and Bharat Biotech, after deliberating upon their applications seeking emergency use authorization for the shots, official sources said.
The application by the Indian arm of US pharmaceutical firm Pfizer was not taken up for deliberation on Wednesday as the firm sought more time for making presentation before the committee, they said.
While considering Serum Institute’s application, the subject expert committee (SEC) of the CDSCO is learnt to have asked for updated safety data of phase-2 and phase-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 Medicines and Healthcare products Regulatory Agency (MHRA), sources said.
As for Hyderabad-based Bharat Biotech, after detailed deliberations, the SEC recommended that the firm should present the safety and efficacy data from the ongoing phase-3 clinical trial in the country for further consideration, the source said.
Bharat Biotech had applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for its indigenously developed COVID-19 vaccine Covaxin on December 7, while Pune-based Serum Institute sought the nod for the Oxford COVID-19 vaccine, Covishield, on December 6.