ASTRAZENECA TO SEEK US APPROVAL OF COVID VACCINE IN 2ND HALF

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.

“We have an enormous amount of data, clinical data and all of the data coming from the work we’ve done around the world,” AstraZeneca CEO Pascal Soriot said on a conference call with reporters. “A BLA is a much bigger submission than the emergency use approval.”

AstraZeneca has promoted its relatively cheap, easy-to-handle shot as a “vaccine for the world” and has already received authorization from more than 170 countries. The company, which has promised to deliver the vaccine on a nonprofit basis throughout the pandemic, says it provided about 90% of the doses distributed by the COVAX facility for low- and middle-income countries in the first half of the year.