The Food and Drug Administration has cleared Novavax to move forward with testing of a combination vaccine for COVID-19 and influenza as well as of its standalone flu shots, ending a pause that began after a serious adverse event report last month.
The agency authorized Novavax to start a Phase 3 trial of its combination shot after the company “satisfactorily” addressed the FDA’s concerns, the company said in a Monday statement. Trial activities will resume “as quickly as possible,” Novavax added. The lifted hold applies to Novavax’s flu-only programs as well.
The announcement officially ends a weekslong delay that started on Oct. 16, when Novavax disclosed in a regulatory filing the occurrence of a serious adverse event in a Phase 2 trial of its combo vaccine. A trial participant who’d received the shot in Jan. 2023 later developed motor neuropathy, or muscle weakness, leading the FDA to pause testing of that vaccine and Novavax’s standalone flu shots while it reviewed the case.
In a statement Monday, Novavax said the additional information that’s come to light has led to a change in how the adverse event is being classified. The event is now judged to be ALS, a rare neurodegenerative disease that’s not known to be associated with vaccination and in this case was deemed unrelated to Novavax’s shot.
"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,” said Robert Walker, Novavax’s chief medical officer, in a statement.
Novavax had been hoping to find a sizable sales opportunity by advancing a protein-based alternative to the messenger RNA shots Pfizer and Moderna developed for COVID. But the company was late to market and has since seen slow uptake of its vaccine, causing its share value to plummet and the company to cut staff in response. Novavax has responded by developing a combination shot and earlier this year got an endorsement from Sanofi, which paid it $500 million to develop that program and other multi-pronged vaccines.
Novavax didn’t specify when to expect results from its Phase 3 trial. Shares ticked up about 2% early Monday, but still traded at less than $10 apiece.
