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 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 UK 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 with additional information will continue to connect with the authority and resubmit its approval request 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.