![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Pfizer Withdraws Emergency Use Application of COVID-19 Vaccine in India
Pfizer Withdraws Emergency Use Application of COVID-19 Vaccine in India
![pfizerlogo.gif](https://www.fdanews.com/ext/resources/test/Drug-Images/pfizerlogo.gif?t=1576044507&width=430)
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Pfizer has withdrawn its application for emergency use approval of its COVID-19 vaccine in India after the country’s drug regulator requested a domestic trial.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.
Upcoming Events
-
21Oct