Novavax to Submit COVID-19 The Vaccine EUA Request to US FDA Next Month
(Reuters) – Novavax Inc will submit a request to the U.S. Food and Drug Administration to approve its COVID-19 vaccination next month, the company said on Friday.
This announcement comes after the final data regarding the vaccine’s manufacturing process was presented to the regulator. This was a prerequisite to the emergency use authorization application.
This is yet another delay for the vaccine manufacturer, who earlier this month stated that it would submit its EUA submission by the end of 2013.
Novavax has been forced to delay its U.S. submission multiple times due to manufacturing and development delays. A report earlier this year said the methods Novavax used to test the effectiveness of its vaccine fell short of regulators’ standards.