Covid-19 Vaccines: CDSCO Expert Panel Seeks More Data From Serum Institute, Bharat Biotech
The applications of both Bharat Biotech and the Serum Institute are still under consideration, a source told PTI.
An expert committee of the Central Drugs Standard Control Organisation on Wednesday sought additional safety and efficacy data for Covid-19 vaccine candidates of Serum Institute of India Ltd. and Bharat Biotech International Ltd., after deliberating upon their applications seeking emergency use authorisation for the shots, official sources told PTI.
The application by the Indian arm of U.S. pharmaceutical firm Pfizer Inc. was not taken up for deliberation on Wednesday as the firm sought more time for making presentation before the committee, they said.
The applications of both Bharat Biotech and the Serum Institute are still under consideration, a source told PTI.
While considering Serum Institute's application, the subject expert committee 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 U.K. and India, along with the outcome of the assessment of the U.K. Medicines and Healthcare products Regulatory Agency, 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 for emergency use authorisation for its indigenously developed Covid-19 vaccine Covaxin on Dec. 7, while Pune-based Serum Institute sought the nod for the Oxford coronavirus vaccine, Covishield, on Dec. 6.
Pfizer had applied for emergency use authorisation for its vaccine on Dec. 4.
