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July 30, 2021

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AstraZeneca delays approval bid in US

AstraZeneca said yesterday it intends to seek US approval for its COVID-19 vaccine sometime 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 US 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.

“We have an enormous amount of data, clinical data and all of the data coming from the work we’ve done around the world,” CEO Pascal Soriot said on a conference call with reporters.

“A BLA is a much bigger submission than the emergency use approval.”

The news on the US filing is being closely watched because the timetable has slipped in recent months.

When AstraZeneca released data from its US trial of the vaccine on March 22, company officials said they expected to seek FDA authorization in the first half of April.

Among the concerns AstraZeneca will have to address are reports that the vaccine may be linked to rare blood clots.

These have caused some countries to limit its use in younger people.

The AstraZeneca vaccine is already in widespread use around the world following approval by regulators in the European Union, World Health Organization, UK and other countries.


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