FDA lifts clinical hold on Novavax's COVID-flu combo and standalone flu vaccines

NOVAVAX INC

FDA removed clinical hold on Novavax's IND for CIC and stand-alone influenza candidates on Nov 11.
Hold was placed Oct 16 due to a serious adverse event (motor neuropathy, later ALS) in a Phase 2 participant.
Novavax provided additional data confirming the event was not related to the vaccine.
FDA cleared Novavax to begin enrollment in the planned Phase 3 trial for both vaccine candidates.
Novavax will work with investigators to resume trial activities as quickly as possible.

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