LONDON (AP) — AstraZeneca said Thursday that it intends to seek U.S. approval for its COVID-19 vaccine later this year, further delaying the application even as the company announced it had already delivered more than 1 billion doses to other countries.
The Anglo-Swedish drugmaker said the application has been delayed because it has decided to ask the U.S. Food and Drug Administration for full regulatory approval, 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.
