Pfizer, one of the worlds largest Pharma company on Friday (5 February) said it has decided to withdraw its application for Emergency Use Authorisation (EUA) of its COVID-19 vaccine in India.
It must be noted that Pfizer was the first pharmaceutical company to seek clearance for emergency use authorisation from the Drugs Controller General of India (DCGI) for its COVID-19 vaccine as 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 also stated that it will continue to engage with the Indian authority and resubmit its approval request. In its next attempt, Pfizer will provide additional information said 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.
Pfizer is one of the most influential pharmaceutical company tried it very bet in its application to the drug regulator in December 2020, and sought permission to import the vaccine in India and at the same time asked for a waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019.
The other reason for Pfizer to withdraw its application to supply Covid-19 vaccine was the introduction of the indigenous covax vaccine developed by Bharat Biotech which is cheaper with a high efficacy rate.
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