Novavax’s stock price dropped Wednesday after the FDA halted clinical trials of the company’s investigational COVID-19/influenza vaccine and single-type influenza vaccine after reports of serious adverse events in trial participants. It fell 16%.
Novavax said its standalone coronavirus vaccine — its only product currently on the U.S. market, competing with giants Pfizer/BioNTech and Moderna — is not affected by the FDA hold.
Novavax said in a short press release that the decision was based on reports of a serious adverse event of motor neuron impairment in a Phase II trial participant outside the U.S. The company said the adverse event was not related to the vaccine candidate. He emphasized that they are not related. Research in progress. The Phase II trial ended in June 2023, and the company had applied to the FDA to begin a Phase III trial when the adverse events were reported last month. Novavax said no cases of motor neuropathy were observed during the Phase II trial.
“We are working closely with the FDA to provide the necessary information to help them better understand this finding and resolve the clinical hold,” Robert Walker, Novavax’s chief medical officer, said in a statement. ” he said. “Our goal is to successfully resolve this issue and begin Phase III trials as soon as possible.”
Motor neuropathy is a rare acquired immune-mediated disease that causes muscle weakness in the arms and legs. Cases of adverse events had previously been reported by some people who received other coronavirus vaccines, such as the Pfizer/BioNTech product, but the complications were not linked to vaccination.
Novavax has had a difficult road to bring its COVID-19 vaccine to market, winning emergency use authorization far behind market leaders Pfizer/BioNTech and Moderna. But Novavax’s shot offers an alternative to mRNA technology and has gained an almost cult-like following among people seeking a third option during the hectic days of the pandemic.
