Novavax announced that the FDA has placed a clinical hold on its investigational COVID-19-influenza combination (CIC) and stand-alone influenza vaccine candidates.
The hold follows a serious adverse event reported by a participant in the CIC phase 2 trial, conducted outside the U.S. in early 2023. The participant experienced motor neuropathy, which was reported in September 2024, months after the trial concluded in July 2023.
The company said it's working closely with the FDA to provide additional data and clarify the situation surrounding the adverse event. While Novavax has not established a direct link between the vaccine and the event, the company remains focused on resolving the issue quickly to move forward with its phase 3 trials.
Previous data from Novavax’s COVID-19 and influenza trials have not indicated any signs of motor neuropathy, and other investigational new drugs for its COVID-19 vaccine are not impacted by this clinical hold. Investigators involved in the trials have already been informed of the FDA’s decision.
