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Pfizer Withdraws Emergency Use Application of COVID-19 Vaccine in India

February 9, 2021

Pfizer has withdrawn its application for emergency use approval of its COVID-19 vaccine in India after the country’s drug regulator requested a domestic trial.

India’s vaccine regulatory authority called for a study on safety and immune responses in its population, while Pfizer sought to have the trial requirements waived based on its currently available global phase 3 data.

The company said it “remains committed to making its vaccine available” in India and plans to resubmit its approval request with additional information as it becomes available.

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