AstraZeneca’s having second thoughts about its COVID vaccine business as FDA filing drags on.

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AstraZeneca’s COVID-19 vaccine has faced controversies ranging from clinical data clarity to harmful side effects. Now, as the shot takes even longer to reach the U.S., the drugmaker is having second thoughts about the business.

AstraZeneca is “exploring different options” for the COVID vaccine it licensed from the University of Oxford, Ruud Dobber, AZ’s chief of the biopharmaceuticals business unit, told R___ers. The company will “have more clarity” by the end of the year, he added.

“Is the vaccine businesses a sustainable business for AstraZeneca for the next five or 10 years, that big strategic question is under discussion,” Dobber said, as quoted by R___ers.

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AstraZeneca’s strategic evaluation comes as a U.S. filing of the vaccine takes longer than expected and as the vaccine hurts AZ’s overall profit.

The drugmaker now expects to submit its FDA application by the end of this year. Back in April, the company was looking at a timeline of “in the coming weeks.” The British pharma is skipping the emergency use authorization process and has been eying a full U.S. approval.

As AstraZeneca CEO Pascal Soriot pointed out on a call Thursday, the application package for a full approval is much larger than an EUA dossier. It’s typical for a drugmaker to take six or seven years to prepare for an FDA filing after wrapping up phase 3 testing, he noted.

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AZ licensed its COVID-19 shot from Oxford last May.
Without prior experience in human vaccines, the company has found itself embroiled in several controversies since then, including a dosing mix-up in a key efficacy trial, a data miscommunication that drew censure from the National Institutes of Health, a legal tussle with the EU, plus concerns over the shot’s rare side effects. But to hear Soriot tell it, despite all the challenges, the shot is still playing an important role in the pandemic.

www.fiercepharma.com/pharma/astrazeneca-weighs-options-for-covid-vaccine-business-as-fda-filing-drags

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