Novavax’s post-Covid path ran into a speed bump Wednesday, as the company announced a clinical hold on its Covid-influenza combination vaccine and its standalone flu shot.
The FDA placed the hold after an individual outside the US reported a side effect of “motor neuropathy,” according to a press release. The individual was participating in Novavax’s Phase 2 trial for the combination shot, which wrapped up in July 2023, and reported the side effect last month.
Robert Walker“While we do not believe causality has been established for this serious adverse event, we are committed to working expeditiously to fulfill requests for more information from the FDA,” Novavax CMO Robert Walker said in a statement.
Novavax’s stock price $NVAX fell by as much as 20% on Wednesday morning.
The company had been planning to launch a Phase 3 trial for the combination and standalone flu vaccines in the second half of this year, saying in February that its goal was to achieve an accelerated approval in 2026. As recently as August, Novavax had guided toward a fourth-quarter trial launch and mid-2025 data readout.
Previous trials had not shown any incidence of motor neuropathy in either the Covid-19 or influenza vaccines, Novavax said. The company’s standalone Covid-19 shot is not affected by the hold.