On October 16, 2024, Novavax, Inc., a biotechnology company specializing in protein-based vaccines, announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its Investigational New Drug (IND) applications for both its COVID-19-Influenza Combination (CIC) vaccine and its standalone influenza vaccine candidates. The hold was initiated following a report of a serious adverse event (SAE) of motor neuropathy in a participant from a Phase 2 trial of the CIC vaccine conducted outside the United States. The participant received the vaccine in January 2023, the trial concluded in July 2023, and the SAE was reported in September 2024. Novavax is working with the FDA to resolve the clinical hold and aims to commence the Phase 3 trial as soon as...Show More

On October 16, 2024, Novavax, Inc., a biotechnology company specializing in protein-based vaccines, announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its Investigational New Drug (IND) applications for both its COVID-19-Influenza Combination (CIC) vaccine and its standalone influenza vaccine candidates. The hold was initiated following a report of a serious adverse event (SAE) of motor neuropathy in a participant from a Phase 2 trial of the CIC vaccine conducted outside the United States. The participant received the vaccine in January 2023, the trial concluded in July 2023, and the SAE was reported in September 2024. Novavax is working with the FDA to resolve the clinical hold and aims to commence the Phase 3 trial as soon as possible. The company's previous trials for COVID-19 and influenza vaccines did not show any signs of motor neuropathy. The clinical hold does not affect Novavax's IND for its standalone COVID-19 vaccine. Novavax's Chief Medical Officer, Dr. Robert Walker, emphasized the company's commitment to safety and resolving the FDA's concerns promptly.