The U.S. Food and Drug Administration (FDA) has paused a trial of Novavax’s COVID-19-flu combination vaccine and standalone flu vaccine after a participant reported nerve damage.
“The clinical hold is due to a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single [COVID-19-Influenza Combination] Phase 2 trial participant outside of the U.S. who received the vaccine in January 2023,” Novavax said in a press release. “The trial completed in July 2023 and the participant reported the SAE in September 2024.”
Novavax’s Chief Medical Officer, Robert Walker, said in a statement that the company is “working closely with the FDA to provide the necessary information that will allow them to better understand this observation and resolve the clinical hold.”
“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 3 trial as soon as possible.”
The company added that its previous COVID-19 and influenza trials did not show any signs of contributing to motor neuropathy.
Novavax’s shares fell 24% following the announcement, Reuters reported.
American Faith reported that Novavax’s updated COVID-19 vaccine was cleared without using clinical data.
According to a press release from the FDA, the agency used “manufacturing and nonclinical data to support the change to the 2024-2025 formula.”
Despite the lack of clinical data, Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research, said that the new authorization “provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”
