Pfizer withdraws Emergency Use Authorisation application for its COVID-19 vaccine in India
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The firm mentioned it was withdrawing its application primarily based on its “understanding of additional information that the (Indian drugs) regulator may need”.
Pharma main Pfizer on February 5 mentioned it has determined to withdraw its application for Emergency Use Authorisation (EUA) of its COVID-19 vaccine in India.
Pfizer was the first pharmaceutical firm to hunt an emergency use authorisation from the Drugs Controller General of India (DCGI) for its COVID-19 vaccine in the nation, after it secured such clearance in the U.K. 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,” an organization spokesperson mentioned in an announcement.
Pfizer will proceed to interact with the authority and resubmit its approval request with further data because it turns into accessible in the close to future, the assertion mentioned.
“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 mentioned.
Pfizer in its application submitted to the drug regulator in December 2020, had sought permission to import the vaccine for sale and distribution in India, apart from waiver of scientific trials on Indian inhabitants in accordance with the particular provisions beneath the New Drugs and Clinical Trials Rules, 2019, official sources had mentioned.
