• The FDA has placed a clinical hold on Novavax's combined COVID-19 and flu vaccine program following a report of motor neuropathy in a Phase 2 trial participant.
• Novavax is working to provide the FDA with the necessary information to resolve the hold, though the company states causality has not been established.
• The clinical hold delays the development of Novavax's combined vaccine candidate, while Moderna is ahead with positive Phase 3 data for its own combined vaccine.
• Novavax has launched its latest coronavirus vaccine for the current season, available in more locations and in a prefilled syringe, potentially boosting its market presence.