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

Pfizer withdrew its application for emergency use approval of its COVID-19 vaccine in India after the country’s 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.