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Pfizer withdraws emergency use application in India

Seeking more information, Indian drug regulator says no approval without local trial on vaccine safety

Cheena Kapoor  | 05.02.2021 - Update : 05.02.2021
Pfizer withdraws emergency use application in India


US-based pharmaceutical company Pfizer has withdrawn its application for emergency-use authorization of its COVID-19 vaccine in India after the drug controller demanded additional information.

“In pursuance of the Emergency Use Authorization of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on Feb. 3. Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future,” a statement by the company said.

The pharma company has developed the COVID-19 vaccine BNT162b2.

Pfizer was the first to seek the emergency authorization of its vaccine in the country last year, but the Indian government approved two less expensive vaccines - Covishield developed by Oxford University/AstraZeneca and another indigenous Covaxin developed by Bharat Biotech.

The drug regulator confirmed that the request for approval without a local trial on the vaccine safety in the Indian population was declined. Minutes of the meeting released by the Subject Expert Committee denied “grant of permission for emergency use in the country at this stage.”

The committee noted that incidents of palsy, anaphylaxis, and other reactions have been reported, which are being investigated.

In an earlier public statement, Pfizer, however, had confirmed that its vaccine has a 95% efficacy rate globally.

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