Novavax shares plunge after FDA places a hold on its flu shots
(Bloomberg) — Novavax Inc. (NVAX) shares fell 20% after US regulators placed a hold on the development of its experimental flu vaccines following a severe adverse event that occurred in a single clinical trial participant.
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The clinical hold applies to the company’s combination influenza and Covid shot and its stand-alone influenza vaccines, it said in a statement.
The patient, who developed motor neuropathy, received a combination flu and Covid shot in January 2023 in a study that was taking place outside of the US. The trial was completed in July 2023, and the participant reported the complication in September 2024.
The company is working closely with the US Food and Drug Administration to provide the necessary information to resolve the clinical hold, Robert Walker, Novavax’s chief medical officer, said in the statement.
Novavax doesn’t “believe causality has been established for this serious adverse event,” he said.
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