Novavax, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Novavax’s Marketing Authorization Application (IND) for its COVID-19 combination influenza vaccine (CIC) and its stand-alone influenza vaccine. The FDA authorized the company to begin enrollment in the planned Phase 3 trial, after determining that Novavax had satisfactorily resolved all issues related to the suspension of clinical trials. Novavax will work with clinical trial investigators and other partners to resume trial activities as quickly as possible.
The clinical discontinuation announced on October 16, 2024 resulted from a spontaneous report of a serious adverse event in a participant who received the investigational CIC vaccine during a phase 2 trial that ended in 2023. The FDA had requested additional information on this event, initially reported as motor neuropathy. Additional information included a change in the event term to amytrophic lateral sclerosis, a condition not known to be immune-mediated or associated with vaccination, which in this event was assessed as not being related to vaccination.
