FDA slaps CRL on Novavax' COVID-19 flu combo trial IND
Shares of US protein-based vaccine maker Novavax (Nasdaq: NVAX) closed down 19.4% at $10.15 yesterday having dropped as much as 24%, on the news of a setback for its investigational application for a covid vaccine.
The company revealed that the US Food and Drug Administration (FDA) has placed a clinical hold on Novavax' Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates.
Novavax noted that the clinical hold is due to a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single CIC Phase II trial participant outside of the USA who received the vaccine in January 2023. The trial completed in July 2023 and the participant reported the SAE in September 2024.
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