FDA to Review Manufacturing Changes at Novavax Before It Grants EUA

The FDA is reviewing changes to the manufacturing process for Novavax’s COVID-19 vaccine that will delay an Emergency Use Authorization, despite the positive recommendation this week by the FDA’s expert advisory panel on vaccines.

Novavax submitted an amendment to its EUA application on June 3 with updated manufacturing and product information for the agency’s EUA review, the FDA said.

The agency “will carefully review this and any additional information submitted by the firm as part of its ongoing assessment and prior to authorizing the vaccine for emergency use,” an FDA spokesperson said.