Clinical Hold on Novavax Vaccines Lifted

FDA has lifted a clinical hold on a Novavax IND for its Covid-19-influenza combination (CIC) and stand-alone influenza vaccine candidates. The agency said the company can begin enrolling patients in a planned Phase 3 trial following the determination that it satisfactorily addressed all clinical hold issues, according to Novavax.

The clinical hold was placed on 10/16 after the company received a spontaneous report of a serious adverse event in a participant who received the CIC vaccine in a Phase 2 trial that completed in 2023. FDA had requested additional information on the event, which was reported as motor neuropathy. “The additional information included a change in the event term to amytrophic lateral sclerosis, a condition that is not known to be immune-mediated or associated with vaccination, which in this event was assessed as not related to vaccination,” Novavax says.