Influenza-COVID Combo Vaccine Trial Halted Over Safety Concerns

The U.S. Food and Drug Administration (FDA) has put a hold on Novavax’s COVID-influenza combination vaccine and standalone influenza vaccines being tested in clinical trials after a participant reported nerve damage following receipt of the experimental vaccine in January 2024.¹

Reported symptoms were diagnosed as motor neuropathy, a disease process that can be acquired, hereditary or immune mediated that damages nerve fibers, leading to muscle weakness and atrophy. The disease is not usually life-threatening but often progresses and can become debilitating.²

According to Novavax officials, a direct link between the shot and neuropathy has not yet been established, but stated that the company is working closely with the FDA to lift the pause so trials can resume. “Our goal is to successfully resolve this matter and to start our Phase 3 trial as soon as possible,” said Novavax’s chief medical officer, Robert Walker, MD.¹

The pharmaceutical company’s shares plunged 24 percent following news of the FDA’s action. Reportedly, if the decline continues, it could erase almost $400 million from the Novavax’s market value. The drop in shares could jeopardize Novavax’s partnership with French drug maker Sanofi, according to one analyst. In May 2024, Sanofi announced the partnership with Novavax to develop and commercialize a global COVID-influenza combination vaccine.³