FDA Lifts Clinical Hold On Novavax’s Trial Of Combination COVID-Influenza Vaccine

Reuters (11/11, Satija) reports that “the U.S. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax’s COVID-influenza and its standalone flu vaccines after a safety concern was found to be unrelated to the combination shot, the company said.” Novavax “announced the clinical hold last month after a participant who had received its COVID-influenza combination vaccine had reported symptoms of motor neuropathy.” The company “said on Monday it had changed the participant’s symptoms to amyotrophic lateral sclerosis...in additional details provided to the” FDA. The company said “assessment showed the symptoms were not related to its shot.”