09:18 AM EDT, 10/16/2024 (MT Newswires) -- Novavax ( NVAX ) said Wednesday that the US Food and Drug Administration has placed a clinical hold on its investigational new drug application for its COVID-19-influenza combination and standalone influenza vaccine candidates.

The company said the clinical hold is due to a report of a serious adverse event involving motor neuropathy in a phase 2 trial participant outside the US who received the vaccine in January 2023.

The trial was completed in July 2023, and the participant reported the severe adverse event in September 2024, the company said

Novavax ( NVAX ) said its previous COVID-19 and influenza trials have shown no signals for motor neuropathy, and the hold does not affect the COVID-19 investigational new drug application for its COVID-19 vaccine.

Shares of the company fell by more than 20% in premarket trading.

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