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Coronavirus

Pfizer Says It Has Withdrawn Its Application for Emergency Use of Its Vaccine in India

February 5, 2021

NEW DELHI — Pfizer Inc says it has withdrawn its application for emergency use of its COVID-19 vaccine in India.

The company said Friday that it participated in a meeting of experts of the drug regulator on Feb. 3. Based on the deliberation of that 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.

The company was the first to approach the Indian regulator in December for its messenger RNA vaccine that it has developed with Germany’s BioNTech. They were closely followed by applications for two other vaccines — a version of the AstraZeneca made by Serum Institute of India and another by Indian company Bharat Biotech — which eventually got the nod for emergency use on Jan. 3.

However, India’s Health Ministry has said that Pfizer hadn’t made its presentation to experts who needed to clear the vaccine, before the regulator could green-light its use in India.

Pfizer said in the statement that it would continue to engage with authorities and that it was committed to making its vaccine available for use in India. The company said that it would “resubmit its approval request with additional information as it becomes available in the near future.”

It isn’t clear what information the committee of experts had sought from Pfizer on Feb. 3.

Indian Health Ministry officials point out that the Pfizer vaccine isn’t necessarily best suited for India since it requires ultra-cold freezers for storage that aren’t easily available, and due to its high cost.

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