An expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute and Bharat Biotech, after deliberating upon their applications looking for emergency use authorisation for the shots, according to official sources.
They said, the application by the Indian arm of US pharmaceutical company Pfizer was not taken up for consideration on Wednesday as the firm sought more time for making presentation before the committee.
The applications of both Bharat Biotech and the Serum Institute of India are still under consideration, a source told PTI.
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 while considering Serum Institute’s application.
As for Hyderabad-based Bharat Biotech, after detailed deliberations, the SEC recommended that the company should present the safety and efficacy data from the ongoing phase-3 clinical trial in the country for further consideration, the source said.
Pfizer had applied for emergency use authorisation for its vaccine on December 4.
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 got the nod for the Oxford COVID-19 vaccine, Covishield, on December 6.
