AstraZeneca revealed strong Covid-19 vaccine sales but warned it would take even longer to secure approval in the US, the world’s largest pharmaceutical market.
The UK-Swedish group said it might take until the end of the year to submit its Covid vaccine to the US regulator, after deciding to apply for full regulatory approval rather than an emergency use authorisation.
Mene Pangalos, executive vice-president at AstraZeneca, said the US Food and Drug Administration had requested an “awful lot of information”, from trial data to real-world evidence, before even holding the pre-approval meeting to discuss the application.
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