FDA Puts Novavax’s Combo COVID-19/Influenza Vaccine Trial On Hold Over Safety Concerns

October 17, 2024

Reuters (10/16, Satija, Leo) reports the FDA “has put on hold a trial of Novavax’s COVID-influenza and its standalone flu vaccines after a participant who took the combination shot reported nerve damage, the company said on Wednesday.” The company “said a participant enrolled in a mid-stage study of the combination vaccine last month reported symptoms of motor neuropathy.” The individual “was given the vaccine in January last year.” Novavax “said it was not yet established that the vaccine had caused the safety event and it was working with the FDA to resolve the pause.”