Novavax (NVAX, Financial), a U.S. vaccine manufacturer, has encountered a significant hurdle as the U.S. Food and Drug Administration (FDA) paused the clinical trial of its combined flu/COVID-19 vaccine. This decision follows a severe motor neuropathy incident involving a trial participant, causing NVAX's stock to plunge over 20%, albeit with slight recovery.
The FDA also halted a separate new drug application for an independent flu vaccine. The Phase 2 trial for the combined vaccine concluded in July 2023, but a severe adverse event was reported in September. The participant experienced symptoms of motor neuropathy, indicating nerve cell damage affecting muscle control. Despite the occurrence, Novavax claims that other trials showed no safety signals linking the vaccine to neural damage and is working to provide additional data to the FDA.
Novavax is collaborating with the FDA to resolve the clinical hold on both the combined and separate flu vaccine trials. The company's Chief Medical Officer, Robert Walker, expressed their commitment to address the issues and resume Phase 3 trials promptly. However, this setback is significant as Novavax is pushing to bring new products to market amid declining global demand for its COVID-19 vaccine.
Currently, the recombinant protein vaccine is Novavax's sole commercial offering. Last month, the FDA approved a new version of its COVID-19 vaccine, designed to combat prevailing strains, providing an alternative to mRNA vaccines for Americans.
Public health officials maintain that Novavax’s protein-based COVID-19 vaccine is a valuable option for those hesitant to receive mRNA vaccines. The Centers for Disease Control and Prevention (CDC) recently advised that it is an optimal time to receive recommended vaccines, including the latest COVID-19 and flu vaccines, as flu season approaches.
Meanwhile, Pfizer and Moderna's combined flu/COVID-19 vaccines have entered late-stage trials, although Pfizer's vaccine has faced challenges and could see delayed market entry.
