Novavax’s CEO stated this week that the company believes it might get an OK for its COVID-19 vaccine as soon as May.
The company may submit data from a British trial, which is slated for completion in April, for its approval application. But talks with the FDA are ongoing and Novavax may need to submit data from a U.S. trial, which would push an approval date out to late summer.
Novavax has hit snags in the development of its coronavirus vaccine and had to delay the start of its U.S. trials two times due to manufacturing issues. But the company has also secured a 110 million-dose supply agreement with the U.S., which it says it can deliver by the third quarter.
If approved, the Novavax vaccine, which has to be administered in two shots, would be the fourth to win approval in the U.S.
Read the Reuters report.