The U.S. Food and Drug Administration (FDA) placed a clinical hold on the Investigational New Drug application for Novavax’s COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccines. The hold was placed following a report of nerve damage in a trial participant.
The participant received the vaccine in January 2023 as part of a single CIC phase II trial that was completed in July 2023. In September 2024, the participant reported motor neuropathy.
“We are working closely with the FDA to provide the necessary information that will allow them to better understand this observation and resolve the clinical hold,” said Robert Walker, MD, chief medical officer of Novavax. “It is important to note that safety is our top priority, and while we do not believe causality has been established for this serious adverse event, we are committed to working expeditiously to fulfill requests for more information from the FDA. Our goal is to successfully resolve this matter and to start our phase III trial as soon as possible.”
Source: Novavax, October 16, 2024.
