Novavax reports that the FDA has clinically suspended the IND for its COVID-flu combination vaccine

Novavax announced that the U.S. Food and Drug Administration has deferred Novavax’s Investigational New Drug (IND) application for its COVID-19 influenza combination (CIC) and standalone influenza vaccine candidates. “The clinical suspension is due to a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single CIC Phase 2 study participant outside the United States who received the vaccine in January 2023. The study was completed in July 2023. One participant reported the SAE in September 2024. Data from Novavax’s previous COVID-19 and influenza studies showed no evidence of motor neuropathy. The investigators were informed about this action. The COVID-19 IND for Novavax’s COVID-19 Vaccine is not affected by the clinical suspension,” the company stated. “We are working closely with the FDA to provide the necessary information to allow them to better understand this observation and resolve the clinical impasse,” said Dr. Robert Walker, chief medical officer of Novavax. “It is important to note that safety is our top priority, and while we do not believe a causal relationship has been established for this serious adverse event, we are committed to working expeditiously to respond to FDA’s requests for additional information.” Our goal is to successfully resolve this matter and begin our Phase 3 trial as quickly as possible.”

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