Novavax today announced that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on Novavax’s Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates.
The FDA has cleared the company to begin enrolling the planned Phase 3 trial following the determination that Novavax satisfactorily addressed all clinical hold issues.
The clinical hold announced on October 16, 2024, resulted from a spontaneous report of a serious adverse event in a participant who received investigational CIC vaccine in a Phase 2 trial that completed in 2023. The FDA had requested additional information on this event, initially reported as motor neuropathy. Following investigation, the event was determined to be amytrophic lateral sclerosis (ALS), a condition that is not known to be immune-mediated or associated with vaccination.
Novavax will be working with the clinical trial investigators and other partners to resume trial activities as quickly as possible.
“We thank the FDA for their partnership and thorough review of the additional information provided as part of our response package,” said Robert Walker, MD, Chief Medical Officer, Novavax. “The information provided to the FDA supported our assessment that the serious adverse event was not related to our vaccine. We plan to start our Phase 3 trial as soon as possible.”
In August 2024, the FDA granted an EUA for Novavax’s updated COVID-19 vaccine in persons 12 and older.
Research suggests that the Novavax protein subunit vaccine is about as safe and effective as the mRNA shots. Its main disadvantage is arriving late to the scene after mRNA vaccines were widely funded and distributed.