Pfizer Withdraws Emergency Use Request for its Covid Vaccine in India

NEW DELHI: The United States based pharma major Pfizer on Friday 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 company to request an emergency use authorisation from the Drugs Controller General of India (DCGI) for its COVID-19 vaccine in the country after it secured the same clearance from the United Kingdom and Bahrain.

Pfizer had applied for the emergency use authorisation to DCGI on December 6 last year.

The company released a statement which said "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."

The statement also said that the pharma firm will continue to engage with the authority and resubmit its approval request with additional information as it becomes available in the near future.

"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 statement said.

Pfizer had requested 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.

In January, the Indian government approved two relatively inexpensive vaccines from Oxford University (AstraZeneca) and Bharat Biotech. Both companies had applied for sanction of their vaccines after Pfizer. India's Central Drugs Standard Control Organisation had declined to accept Pfizer's request for approval without a small local trial on the vaccine's safety and immunogenicity for Indians, Reuters has reported.

The United Kingdom became the first country in the world to administer the Covid-19 vaccine produced by Pfizer and BioNTech in collaboration. Later, Canada, Mexico and the US approved the vaccines for use in their countries.

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