Novavax, Inc. (NVAX) announced on Wednesday that the U.S. Food and Drug Administration (FDA) has imposed a clinical hold on its COVID-19-Influenza Combination (CIC) and its stand-alone influenza vaccine candidates. This decision follows the report of a case of motor neuropathy in a trial participant who had received the CIC vaccine in January 2023. Consequently, Novavax's shares dropped over 14 percent in pre-market trading.
The clinical trial was concluded in July 2023, but the participant only reported the serious adverse event (SAE) involving motor neuropathy in September of this year.
"We are collaborating closely with the FDA to furnish all necessary information that will enable a thorough understanding of this occurrence and facilitate the lifting of the clinical hold," stated Robert Walker, Chief Medical Officer at Novavax.
According to a company statement, the clinical hold does not affect the Investigational New Drug (IND) application for Novavax's COVID-19 vaccine.
Prior to this development, Novavax's stock had closed at $12.60 on Tuesday, showing a slight decline of 0.16 percent. Over the past year, the stock has fluctuated between $3.53 and $23.86.
