Novavax (NVAX, Financial) experienced a significant drop in stock value, falling nearly 30% in pre-market trading. This reaction came after the U.S. Food and Drug Administration (FDA) paused the new drug application for Novavax's combined COVID-19 and flu vaccine, as well as its standalone flu candidate. The suspension occurred due to a severe adverse event reported by a trial participant.
At the time of reporting, Novavax shares were down by 16.83%, trading at $10.61. The FDA specified that the clinical hold was enacted following the spontaneous report of a severe motor neuropathy adverse event by a participant outside the U.S. who was vaccinated in January 2023, during a Phase 2 trial of the combined vaccine, which concluded in July 2023.
Novavax's Chief Medical Officer, Robert Walker, mentioned that the company is working closely with the FDA to provide additional information to better understand the observations and resolve the clinical issues. The company clarified that prior trials for their COVID-19 and flu vaccines showed no signs of motor neuropathies, and the clinical hold does not affect their research on the independent COVID-19 vaccine application.
