www.fdanews.com/articles/201282-pfizer-withdraws-emergency-use-application-of-covid-19-vaccine-in-india
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Pfizer has withdrawn its application for emergency use approval of its COVID-19 vaccine in India after the country’s drug regulator requested a domestic trial.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.