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# Last Minute Manufacturing Data Delays Novavax Vaccine
- URL: https://www.fdaweb.com/last-minute-manufacturing-data-delays-novavax-vaccine/
- Published: 2022-06-09T12:00:00.000Z
- Updated: 2026-09-14T17:48:03.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152025

Fresh off a positive FDA advisory committee vote ([see earlier story](https://www.fdaweb.com/fda-panel-backs-novavax-covid-19-vaccine/)) to recommend an emergency use authorization of its Covid-19 vaccine, Novavax now finds its vaccine stalled at the agency because of last minute manufacturing data the company submitted, which have to be reviewed before the agency renders a decision on the EUA. Previous Covid-19 vaccine decisions were made shortly after the advisory committee deliberated.

FDA’s Vaccines and Related Biological Products Advisory Committee 6/7 voted unanimously (21 to 0) to recommend that the agency grant Novavax an emergency use authorization for its Covid-19 vaccine and its use in individuals 18 years of age and older. Data showed that the efficacy against confirmed mild, moderate or severe Covid-19 was 90.4%. Like the currently approved mRNA vaccines, Novavax’s vaccine was also associated with multiple events of myocarditis/pericarditis.

Responding to the late manufacturing data submission, the company said it was part of its routine process improvements, submitted 6/3.