Written by Ciara Linnaeus
The move comes after one participant in a mid-term trial reported a case of motor neuron impairment.
Novavax Inc. stock fell 19% early Wednesday after the U.S. Food and Drug Administration announced it had placed a clinical hold on its combined COVID-19 and influenza vaccine and standalone influenza vaccine candidate. . Participants in the mid-term trial.
According to the National Library of Medicine, motor neuropathy is a neurological disease that causes muscle weakness in the hands and arms, leaving patients unable to perform simple daily tasks.
One case occurred in a Phase 2 trial being conducted outside the United States in patients who received the vaccine in January 2023. The trial ended in July of the same year, and participants reported serious adverse events in September 2024. The company’s investigational drug application for its vaccine is on clinical hold.
“We are working closely with the FDA to provide them with the information they need to better understand this finding and resolve the clinical hold,” said Robert Walker, Novavax’s (NVAX) chief medical officer. “I am,” he said in prepared remarks.
The company said data from previous trials showed no signs of motor neuropathy.
The Novavax vaccine is protein-based and similar to conventional vaccines, in that it is similar to the mRNA vaccine developed by Pfizer Inc. (PFE) and German partner BioNTech SA (BNTX) and the mRNA vaccine developed by Moderna Inc. (MRNA). It is different from
The FDA approved the company’s coronavirus vaccine in October 2023.
The stock is up 111% year-to-date, while the S&P 500 SPX is up 22%.
-Ciara Linnen
This content was generated by MarketWatch, a Dow Jones Company. MarketWatch is published independently of the Dow Jones Newswires and the Wall Street Journal.
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10-17-24 0835ET
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