Pfizer Withdraws Application for COVID Vaccine Approval in India

Pfizer will continue to engage with the authority and resubmit its approval request with additional information.

Pfizer-BioNTech is yet to be approved by DCGI. 

(Photo: iStock)

American pharma giant Pfizer has withdrawn its application for emergency use authorisation (EUA) of its COVID-19 vaccine in India, reports said on Friday, 5 February.

"In pursuance of the emergency use authorisation (EUA) of its COVID-19 vaccine, Pfizer participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on 3 February. 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 was quoted as saying.

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," the spokesperson added.

“Pfizer remains committed to making its vaccine available for use by the Government in India and to pursuing the requisite pathway for EUA that enables the availability of this vaccine for any future deployment.”

Pfizer spokesperson

Pfizer, which had developed the vaccine with BioNTech, was the first to apply for EUA in India, before the applications of Serum Institute of India (SII) and Bharat Biotech for their respective vaccines.

Both SII's 'Covishield' and Bharat Biotech's 'Covaxin' were approved by India's drug regulator early in January, with the vaccine rollout starting on 16 January.

Since then, more than 49 lakh people have received the vaccine shots in the country under the first phase.