Novavax again delays seeking U.S. approval for COVID-19 vaccine

Novavax Inc on Thursday again delayed its timeline for seeking U.S. authorization for its two-dose COVID-19 vaccine, and the company now expects to file for its emergency use in the fourth quarter of 2021.

It had previously said it would seek emergency use authorization (EUA) from the U.S. Food and Drug Administration in the third quarter. Novavax shares dropped 8.5% in after-hours trading. "It's a matter of getting validation work done" to demonstrate consistency in the vaccine's manufacturing process to the FDA, said Chief Executive Officer Stanley Erck, adding that other countries' regulators have been more aggressive in moving Novavax's vaccine through the authorization process.