Pfizer withdraws application for emergency use of its COVID-19 vaccine in India: Report

Pfizer Inc has reportedly withdrawn application for emergency-use authorization of its COVID-19 vaccine in India.

The US-based pharma company is developing vaccines with Germany’s BioNTech.

The company had sought the permission from Drugs Controller General of India for emergency use of its vaccine which has shown 95 per cent efficacy against coronavirus during a preliminary clinical trial data analysis, on December to become the first company to seek permission for the coravirus vaccine in India.

According to Reuters, the company decided to withdraw its application after a meeting with the drug regulator of India which urged company to submit more information about the vaccine.

“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,” it said in a statement to Reuters, adding it will in the future look to resubmit its application with the additional information that the regulator requires.

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

In response, the Indian drug regulator committee said not recommended granting permission for emergency use for Pfizer’s Covid-19 vaccine, a report by LiveMint said.

In a statement, the CDSCO’s expert committee said, “Pfizer did not propose any plan to generate safety and immunogenicity data in Indian population,” the LiveMint reported.

The committee also said that it noted side effects reported abroad, causality of events being investigated.

Pfizer and BioNTech SE has received emergency use authorization only from UK and Bahrain so far.