AstraZeneca will no longer pursue U.S. FDA approval for its COVID-19 vaccine — branded abroad as Vaxzevria — citing declining market needs.
"As the primary vaccination needs of the U.S. are being met already, AstraZeneca has decided that it will not submit a Biologics Licence Application for Vaxzevria in the U.S. The company will continue to focus its efforts on ensuring availability of Vaxzevria elsewhere around the world, including submissions for its use as a booster," the company stated within its Q3 results announcement.
Vaxzevria recently has its conditional marketing authorization in the EU converted into a standard marketing authorization by the EMA. The full authorization covers the use of Vaxzevria in both a primary vaccination series and as a third dose booster.
The vaccine, however, brought in just $180 million in Q3, "a sharp decline in total due to softening demand," according to AstraZeneca, noting that revenue in the third quarter decreased by 83% due to the conclusion of many of the initial Vaxzevria contracts.
Evusheld — the company's long-acting monoclonal antibody under emergency use authorization in the U.S. for the prevention of COVID-19 in immunocompromised people – faired much better, bringing $536 million in Q3.
