Pfizer withdraws Emergency Use Authorisation application for its COVID-19 vaccine in India


The company said it was withdrawing its application based on its “understanding of additional information that the (Indian drugs) regulator may need”.

Pharma major Pfizer on February 5 said it has decided to withdraw its application for Emergency Use Authorisation (EUA) of its COVID-19 vaccine in India.

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, after it secured such clearance in the U.K. and Bahrain.

“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,” a company spokesperson said in a statement.

Pfizer will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future, the statement 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,” the spokesperson said.

Pfizer in its application submitted to the drug regulator in December 2020, had sought permission to import the vaccine for sale and distribution in India, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019, official sources had said.

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