The FDA has put on hold the investigational new drug (IND) applications for Novavax’s combination COVID-19 and influenza vaccine candidate and standalone influenza vaccine candidate. This hold does not affect standalone COVID-19 vaccines.
The FDA’s decision follows reports of serious adverse events from patients outside the United States who participated in a Phase 2 trial of the combination vaccine, which was completed in July 2023.
The participant was vaccinated in January 2023, but reported the onset of motor neuropathy in September of this year. Following this report, the FDA halted vaccine development to investigate whether the adverse events were related to the vaccine candidate.
Robert Walker, Novavax’s chief scientific officer, said the company has no reason to believe the adverse event was caused by the vaccine. No other cases of motor neuropathy have been reported in previous clinical trials evaluating the combination of COVID-19 and influenza vaccines.
“We are working closely with the FDA to provide the necessary information to help them better understand this finding and resolve the clinical hold,” Walker said. “It is important to note that safety is our top priority, and although we do not believe that a causal relationship with this serious adverse event has been established, we do not believe that a causal relationship with this serious adverse event has been established, but we look forward to receiving further information from the FDA.” Our goal is to successfully resolve this issue and begin Phase 3 clinical trials as soon as possible. ”
Results from completed Phase 2 trials were positive for both combination and single influenza vaccines. For the influenza vaccine candidate, the response was significantly higher than the two commercially available influenza vaccines, Novartis’ Fluad and Sanofi’s Fluzone.
Novavax had planned to begin Phase 3 trials of both its combined and single influenza vaccines later this year, but this could be affected by a clinical hold by the FDA.
The news comes as the company implements a strategy to reduce annual expenses and R&D costs by more than 50%. This includes two layoffs earlier this year that reduced the company’s workforce by about 30%.
