New Delhi: Pfizer Inc. has decided to withdraw its application for Emergency Use Authorisation of its Covid-19 vaccine in India, sources reported on Friday.
Pfizer has taken the decision after understanding what additional information the regulator requires, the spokesperson 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 spokesperson said.
According to the spokesperson, 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.