AstraZeneca cancels plan to file for US approval of COVID vaccine
DoctorEgg


AstraZeneca (NASDAQ:AZN) said it will not submit an application seeking approval of its COVID vaccine Vaxzevria in the U.S.
The British pharma giant noted in its Q3 earnings release that as primary vaccination needs of the U.S. were being met already, it has decided not to submit a Biologics Licence Application (BLA) for Vaxzevria to the U.S. Food and Drug Administration.

The company added that it will continue to focus its efforts to make Vaxzevria available elsewhere in the world, including submissions for its use as a booster.
AstraZeneca CEO Pascal Soriot said the application had become very large and complicated and the company's regulatory staff could better use their efforts elsewhere, The Wall Street Journal
reported citing Soriot on the Q3 earnings call.
In Q3, Vaxzevria sales declined to $173M, compared to $1.05B in Q3 2021. However, COVID therapy Evusheld generated sales of $537M.
AZN +4.03% to $63.51 premarket Nov. 10