FDA places clinical hold on Novavax's combo COVID-flu and standalone flu vaccines after motor neuropathy SAE

NOVAVAX INC

FDA placed clinical hold on Novavax's IND for CIC and standalone influenza vaccine candidates.
Hold triggered by spontaneous report of serious adverse event: motor neuropathy in a single Phase 2 participant.
Participant received vaccine Jan 2023; trial completed Jul 2023; SAE reported Sep 2024.
Clinical hold may delay initiation of Phase 3 immunogenicity trial for CIC and influenza vaccine.
COVID-19 IND for Novavax's COVID-19 vaccine is not impacted by the clinical hold.

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