Bharat Biotech seeks emergency use authorisation for Indian Covid-19 vaccine; expert panel to review

WION Web Team
NEW DELHI Updated: Dec 08, 2020, 07:55 AM(IST)

Bharat Biotech said it found encouraging results after a booster dose was given to trial participants six months from the day they received their second dose Photograph:( Others )

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An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates.

The Hyderabad-based pharmaceutical firm Bharat Biotech applied to the Drugs Controller General of India (DCGI) on Monday for granting emergency use authorisation for its COVID-19 vaccine Covaxin, becoming the third company after American pharma giant Pfizer and Pune-based Serum Institute of India (SII) to seek emergency use authorisation for its Covid-19 vaccine candidate.

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In its application for emergency use approval, Hyderabad-headquartered Bharat Biotech has included interim data from early- to mid-stage human trials of its vaccine candidate Covaxin.

Also read: Serum Institute of India applies for emergency use authorisation for Oxford vaccine

The Drugs Controller General of India (DCGI) had on October 23 granted permission to the firm for conducting a phase-3 clinical trial of Covaxin after assessing the safety and immunogenicity data of phase 1 and 2 trials.

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An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates.

At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a COVID-19 vaccine may be ready in a few weeks. That evening, the Indian arm of US pharmaceutical giant Pfizer had sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain.

The Serum Institute sought the nod for the Oxford COVID-19 vaccine, Covishield, on December 6.

"DCGI has already started processing the applications. The subject expert committee on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9," a source said.

(With inputs from agencies)

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