US-based pharma company Pfizer has withdrawn an application for emergency-use authorization of its COVID-19 vaccine in India, the company spokesperson said.
The company participated in a subject expert committee meeting of the Drug Regulatory Authority of India (DGCI) on Wednesday, following which it has decided to withdraw its application at this time.
In a statement, the Pfizer Company spokesperson said it will continue to engage with the DGCI and resubmit its approval request with additional information as it becomes available in the near future.
Pfizer had applied for the emergency use authorisation to DCGI on December 6.
"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 spokesperson said.
"Pfizer 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 spokesperson added.
The United Kingdom became the first country in the world to administer the new coronavirus vaccine developed jointly by Pfizer and BioNTech. Canada, Mexico, the US are among the countries that later approved the Pfizer-BioNTech Covid-19 vaccine for their citizens.
( With inputs from ANI )
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