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# FDA Holds Novavax Covid/Flu Vaccine IND
- URL: https://www.fdaweb.com/fda-holds-novavax-covid-flu-vaccine-ind/
- Published: 2024-10-16T12:00:00.000Z
- Updated: 2026-09-14T14:44:11.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5157990

FDA has placed a clinical hold on Novavax’ IND for its Covid-19-influenza combination and standalone influenza vaccine candidates. A company [statement](https://ir.novavax.com/press-releases/2024-10-16-Update-on-Novavaxs-COVID-19-Influenza-Combination-and-Stand-alone-Influenza-Phase-3-Trial?ref=fdaweb.com) says the hold is due to a spontaneous report of a serious adverse event of motor neuropathy in a single Covid/influenza combination Phase 2 trial participant outside of the U.S. who received the vaccine in 1/2023 and reported the adverse event in 9/2024\. The Phase 2 trial ended in 7/2023.

Company officials say Novavax is working closely with FDA to provide the necessary information to allow the agency to better understand the observation and resolve the hold.