The US Food and Drug Administration (FDA) has suspended the Novavax clinical trial for the combination of the COVID-19 and flu vaccine. The decision came after a report of nerve damage in a participant after the vaccine. Novavax shares fell about 20% to $10.13 after the news.
A case of nerve damage includes symptoms of motor neuropathy, which affects the nerve cells that control muscles and movement. This event was reported last month by a participant in a mid-stage study of the vaccine. However, Novavax said other trials with the COVID-19 and flu vaccines did not show safety concerns related to motor neuropathy. The company is currently in discussions with the FDA to address the ban and reopen the lawsuit, stressing that there is no established link between the vaccine and the reported safety event.
“Our goal is to successfully resolve this case and begin our Phase 3 trial as soon as possible,” said Robert Walker, Novavax’s chief medical officer.
The company’s only marketed product is the Novavax protein-based COVID vaccine. Despite entering the market, it was not very successful in challenging the dominance of Pfizer/BioNTech and Moderna vaccines.
In a strategic move earlier this year, in May 2024, Novavax signed a licensing agreement with Sanofi, worth at least $1.2 billion. This agreement provided critical funding for Novavax and allowed Sanofi to co-market the Novavax vaccine in most regions. In addition, Sanofi acquired the rights to use the Novavax COVID-19 vaccine along with its own flu vaccines to develop a combination vaccine.
Reuters contributed to this article.
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2024-10-16 16:29:00
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