该试验于2023年7月完成，受试者于2024年9月出现不良事件。Previously, the usa FDA suspended the new drug applications for novavax's COVID-19 and influenza combo vaccine and standalone influenza candidate vaccine due to a severe adverse event reported by a trial participant.
Zhixun Finance App noted that in pre-market trading on Wednesday, novavax (NVAX.US) stock price dropped nearly 30% after the usa FDA suspended its new drug applications for the COVID-19 and influenza combo vaccine as well as the standalone influenza candidate vaccine, citing a severe adverse event by a trial participant. At the time of writing, novavax medical fell 16.83% to $10.61.
The FDA stated: "The clinical hold was due to a trial participant in the Phase 2 CIC study outside the usa who spontaneously reported a severe adverse event of motor neuron disease in January 2023 after receiving the vaccine."
The trial was completed in July 2023, with adverse events occurring in subjects in September 2024.
Novavax's Chief Medical Officer, Robert Walker, stated: "We are working closely with the FDA, providing necessary information to help them better understand this observation and address clinical issues."
The company stated that previous COVID-19 and influenza trials did not show signs of motor neuron disease, and the clinical hold will not affect its independent COVID-19 vaccine research new drug applications.
