The request from the Indian branch of the US pharmaceutical company Pfizer was not discussed on Wednesday as the company sought more time to make a presentation to the committee, they said.
The applications of both Bharat Biotech and the Serum Institute of India are still under consideration, a source told PTI.
In considering the Serum Institute’s request, it emerged that CDSCO’s Subject Matter Expert Committee (SEC) requested updated safety data from phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the Kingdom UK and India, along with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) assessment result, sources said.
As for Hyderabad-based Bharat Biotech, after detailed deliberations, the SEC recommended that the company submit 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 Comptroller General of Drugs of India (DCGI) for emergency use authorization for its locally developed Covid-19 vaccine, Covaxin, on December 7, while the Pune-based Serum Institute was seeking the seen good for Oxford Covid-19 vaccine, Covishield. December 6th.
Pfizer had requested emergency use authorization for its vaccine on December 4.
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