The U.S. Food and Drug Administration (FDA) has halted a Novavax (NASDAQ:) clinical trial for a combined COVID-19 and flu vaccine. The reason for this is a report of nerve damage in a study participant after vaccination. In response to the news, shares of Novavax fell about 20% to $10.13.
The reported case of nerve damage has symptoms of motor neuropathy, which affects nerve cells that control muscles and movements. A participant in a mid-stage trial reported this incident last month. However, Novavax emphasizes that other studies of its COVID-19 and flu vaccines have not shown similar safety concerns. The company is now in close contact with the FDA to address the study halt and to restart investigations as soon as possible. Novavax emphasizes that there is currently no proven connection between the vaccine and the reported safety incident.
Robert Walker, Novavax’s chief medical officer, said: “Our goal is to resolve this matter expeditiously and initiate our Phase 3 trial as soon as possible.”
Novavax’s protein-based COVID vaccine is the company’s only marketed product. Despite its market entry, it was unable to seriously threaten the market leadership of the mRNA vaccines from Pfizer/BioNTech and Moderna.
In a strategic move, Novavax entered into a licensing agreement with Sanofi in May 2024 worth at least $1.2 billion. This partnership secured key financial resources for Novavax and enabled Sanofi to co-promote Novavax’s vaccine in most regions. In addition, Sanofi received the rights to use Novavax’s COVID-19 vaccine in combination with its own flu vaccines to develop a combination vaccine.
Reuters contributed to this article.
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