AstraZeneca to seek US approval for COVID-19 vaccine by second half of 2021

The British-Swedish drugmaker AstraZeneca is planning to seek full approval by the U.S. Food and Drug Administration for its COVID-19 vaccine in the second half of 2021, the company announced in a report on its second quarter results issued Thursday. 

“It’s a good vaccine, and we just want to make sure it’s ready to be used if needed,” said AstraZeneca CEO Pascal Soriot, according to a report by the AP. 

Soriot acknowledged during a call with reporters that even though the U.S. has plenty of vaccines, the company wanted to make sure it could be available in the future if need be.

More than 170 countries have authorized AstraZeneca’s COVID-19 vaccine for use, but it has not won approval in the United States.

The most-commonly used vaccines approved for emergency use in the United States are from Pfizer, Moderna and Johnson & Johnson.  

Following U.S. trial data released in late March, AstraZeneca intended to seek authorization of its vaccine by mid-April, according to the AP.  The company then decided to seek full approval of the vaccine instead of approval through an emergency use authorization. A biologics license application requires at least six months of data.