LONDON (AP) – AstraZeneca said Thursday that it intends to seek U.S. approval for its COVID-19 vaccine in the second half of this year, further delaying the long-awaited application.
The Anglo-Swedish drugmaker announced the new timetable as it said the company and its partners have delivered more than 1 billion doses of the vaccine to over 170 countries where it is already authorized for use. AstraZeneca said it has decided to ask the U.S. Food and Drug Administration for full regulatory approval of the vaccine, rather than the fast-track emergency use authorization originally anticipated.
As part of this Biologics License Application, the FDA has requested extensive data from clinical trials around the world, as well as data on real world use of the vaccine.
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