Pfizer, IBS, Bharat Biotech Covid Vaccine Applications Review Tomorrow: Report


A committee of experts from the Central Standard Medicines Control Organization (CDSCO) will meet on Wednesday to review applications from Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorization for their Covid-19 vaccine candidates. official sources said Monday night.

The decision was made late Monday night after Hyderabad-based Bharat Biotech became the third pharmaceutical company to apply to the Comptroller General of Medicines of India (DCGI) for an emergency use authorization for its Covid-19 vaccine developed in the country, Covaxin.

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On December 4, the Indian arm of US pharmaceutical giant Pfizer applied for approval of its vaccine to the central drug regulator, after the firm obtained such authorization in the UK and Bahrain.

The Pune-based Serum Institute of India sought the go-ahead for the Oxford Covid-19 vaccine, Covishield, on December 6.

“DCGI has already started processing applications. The subject matter expert committee (SEC) on Covid-19 at CDSCO will deliberate on requests from Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorization for their COVID-19 vaccines on December 9, ” said a source.

After the evaluation, the SEC will give its recommendations to the DCGI on whether or not to grant emergency use approval for the candidate vaccines, the source said.

At an all-party meeting held on December 4, Prime Minister Narendra Modi had expressed hope that a Covid-19 vaccine could be ready in a few weeks.

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