The FDA has lifted a clinical hold on Novavax’s COVID-19 and influenza combination vaccine, as well as its stand-alone influenza vaccine, allowing the company to move forward with its phase 3 trial.
Novavax has now received FDA approval to resume enrolling participants after addressing concerns related to a serious adverse event in an earlier study.
The clinical hold, initially placed on October 16, stemmed from a report of a participant developing a serious condition following vaccination in a previous phase 2 trial. Novavax’s Chief Medical Officer, Dr. Robert Walker, clarified that additional information provided to the FDA suggested the event was not related to the vaccine, and the hold has since been lifted.
The trial setback followed a report of motor neuropathy in a participant, which was later updated to amyotrophic lateral sclerosis (ALS), a condition unrelated to vaccination.
