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Pfizer withdraws application for emergency use of its Covid-19 vaccines in India

Pfizer

Delhi:  On Friday, Leading Pharmaceutical Company Pfizer ordered to withdraw its application for Emergency Use Authorisation (EUA) of its COVID-19 vaccine in the nation. 

An expert body under India’s apex drug regulator has recommended against granting approval to Pfizer’s Covid-19 vaccine under emergency use, prompting the company to withdraw its request.

Pfizer was the first pharmaceutical firm to seek an emergency use authorisation from the Drugs Controller General of India (DCGI) for its COVID-19 vaccine in the country. It already secured similar clearances in countries like the UK and Bahrain.

A Company Spokesperson said in a statement, “In pursuance of the Emergency Use Authorisation of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3. Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time.”

They also added that they will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future. They said “Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for emergency use authorisation that enables the availability of this vaccine for any future deployment.”

In December 2020, Pfizer in its application submitted to the ‘Drug Regulator’ sought permission to import the vaccine for sale and distribution in India.

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Ravisha Poddar
the authorRavisha Poddar
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