CDSCO expert panel seeks more data on COVID-19 vaccines from Serum Institute, Bharat Biotech

An expert committee of 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 ir applications seeking emergency use authorization for shots, official sources said.

application by Indian arm of US pharmaceutical firm Pfizer was t taken up for deliberation on Wednesday as firm sought more time for making a presentation before committee, y said.

applications of both Bharat Biotech and Serum Institute of India are still under consideration, a source told PTI.

While considering Serum Institute's application, subject expert committee (SEC) of CDSCO is learned to have asked for updated safety data of phase-2 and phase-3 clinical trials in country, immugenicity data from clinical trial in UK and India, along with outcome of assessment of UK Medicines and Healthcare products Regulatory ncy (MHRA), sources said.

As for Hyderabad-based Bharat Biotech, after detailed deliberations, SEC recommended that firm should present safety and efficacy data from ongoing phase-3 clinical trial in country for furr consideration, source said.

Bharat Biotech had applied to Drugs Controller General of India (DCGI) for emergency use authorization for its indigeusly developed COVID-19 vaccine Covaxin on December 7, while Pune-based Serum Institute sought d for Oxford COVID-19 vaccine, Covishield, on December 6.

Pfizer had applied for emergency use authorization for its vaccine on December 4. 

(IM CREDITS:PTI)