FDA Puts Clinical Hold On Novavax COVID-19-Influenza Combo Vaccine Candidate; Stock Tumbles

(RTTNews) - Novavax, Inc. (NVAX) Wednesday said the U.S. Food and Drug Administration (FDA) has placed a clinical hold on its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates due to the report of motor neuropathy in a trial participant who received the CIC vaccine in January 2023. Novavax shares plunged more than 14 percent in pre-market.

The trial had completed in July 2023 and the participant reported the serious adverse event (SAE) of motor neuropathy in September this year.

"We are working closely with the FDA to provide the necessary information that will allow them to better understand this observation and resolve the clinical hold," said Robert Walker, Chief Medical Officer, Novavax.

The COVID-19 IND for Novavax's COVID-19 vaccine is not impacted by the clinical hold, the company said in a statement.

Novavax stock had closed at $12.60, down 0.16 percent on Tuesday. It has traded in the range of $3.53 - $23.86 in the last 1 year.