New Delhi – The drugmaker company Pfizer said it decided to withdraw its application for EUA in India and will be re-submitting its data with additional information to Drug regulator authority for EUA.
“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. 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.”—A Pfizer Company Spokesperson
Pfizer was the first pharmaceutical company to apply for an emergency use authorisation licensure from the Drugs Controller General of India (DCGI) for its COVID-19 vaccine in India after getting clearance in the UK and Bahrain.