The FDA lifted a clinical hold that had been placed on Novavax’s investigational new drug application after the company addressed concerns related to a serious adverse event reported in a phase 2 trial, according to a Nov. 11 news release from the company.
The event, originally described as motor neuropathy, was later reclassified as amyotrophic lateral sclerosis. The FDA requested additional information, which Novavax provided, confirming that the event was not related to the investigational vaccine.
With the clinical hold now lifted, Novavax plans to resume trial activities and begin enrolling participants for the planned phase 3 studies, the release said.
The hold had been imposed Oct. 16 following the adverse event report from a trial participant who received the CIC vaccine.
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