Novavax Gets FDA Approval To Resume Testing Two Vaccines After Clinical Hold

Core Insights - Novavax has received approval from the FDA to resume testing its combination COVID-19-flu and standalone flu vaccines, which had previously been put on hold due to a serious adverse event reported in a patient [1] - The FDA's clinical hold was lifted after Novavax provided sufficient information addressing the concerns raised, allowing the company to begin enrolling participants for the planned Phase 3 trial [1] - Following the announcement, Novavax's shares increased by 1%, and the stock has risen nearly 90% year-to-date [1] Company Summary - The FDA had previously halted Novavax's vaccine trials after a report of a serious adverse event (motor neuropathy) in a Phase 2 trial participant [1] - Novavax's Chief Medical Officer stated that the data provided to the FDA indicated that the adverse event was unrelated to the vaccine, supporting the company's position [1] - The company is now preparing to initiate its Phase 3 trial as soon as possible [1]