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

Novavax (NVAX) shares edged higher Monday after the drugmaker announced that federal regulators have given the company the go-ahead to continue testing its combination COVID-19-flu and standalone flu vaccines.

The company explained that the U.S. Food and Drug Administration (FDA) removed its clinical hold on the studies, and will allow it “to begin enrolling the planned Phase 3 trial following the determination that Novavax satisfactorily addressed all clinical hold issues.”

The FDA had placed the hold on the testing last month after it received a report that a patient in the Phase 2 trial had “a spontaneous report of a serious adverse event (SAE) of motor neuropathy” after getting the vaccine in January 2023. Officials asked for more information about the case, and Novavax said today that data revealed a change in the event’s term to a condition that was not related to the vaccine. 

Dr. Robert Walker, Novavax’s Chief Medical Officer, said that the information given to the FDA supported its own findings that the shot was not to blame, and that the company plans to start its Phase 3 trial “as soon as possible.”

Shares of Novavax, which rose 1% in recent trading, are up nearly 90% year-to-date.