FDA Places Clinical Hold on Novavax’s COVID-19-Influenza Combination and Standalone Influenza Vaccine Trials

Clinical Hold Reason:
The U.S. Food and Drug Administration (FDA) has placed a clinical hold on Novavax's Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and standalone influenza vaccine candidates due to a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single CIC Phase 2 trial participant outside the U.S.

Timeline:
The participant received the vaccine in January 2023, and the trial concluded in July 2023. The SAE was reported in September 2024.

Company Response:
Novavax is working closely with the FDA to provide necessary information to better understand the observation and resolve the clinical hold. The company emphasizes that safety is its top priority and notes that previous trials have not shown signals for motor neuropathy.

Impact:
The clinical hold does not affect Novavax's COVID-19 vaccine IND. The company aims to start its Phase 3 trial as soon as possible after resolving the matter.

Stock Impact:
Novavax's stock has fallen significantly, with a 16% to 19% decline following the announcement of the clinical hold.