(Bloomberg) — Novavax shares fell 19% after U.S. regulators withheld the company’s experimental vaccine after a study volunteer developed severe neurological damage.
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Novavax said in a statement that the suspension applies to its single-type influenza shot and its combination influenza and coronavirus vaccine. Chief Medical Officer Robert Walker said the company does not believe a causal link has been proven and is working with regulators to resolve the issue.
The volunteer, who developed motor neuropathy and movement problems, was vaccinated with a combination influenza and coronavirus vaccine in January 2023 as part of a study conducted outside the United States. The trial will be completed in July 2023, and there were no signs of complications at that time, Walker said in an interview.
Novavax notified the U.S. Food and Drug Administration as soon as it received reports of adverse events late last month, he said. There were no other signs of serious adverse events, he said.
Novavax and the FDA will work with participants’ medical teams to understand more details, including when exactly the health problems began.
“We will continue to investigate,” Walker said. “Our top priority is to protect the safety of our research participants.”
The FDA declined to comment.
Novavax shot to fame by winning approval for its coronavirus vaccine at the height of the pandemic, but has faced a bumpier road than rivals Pfizer and Moderna. Last year, executives questioned the company’s ability to continue operating.
The company appeared to be turning a corner in May when it signed a $1.2 billion licensing agreement with Sanofi that includes commercializing a combination vaccine against the new flu.
The company’s protein-based approach appeared to be an effective option during the pandemic, when the need for vaccinations became widespread. Despite positive test results and emergency clearance from the FDA, manufacturing delays limited its use.
(Updates shared information in 3rd paragraph and adds details from interview with Chief Medical Officer in 4th paragraph)
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