FDA Places Clinical Hold on Novavax's COVID-19 and Flu Vaccine Candidates, Shares Drop 20%

Oct 16, 2024, 01:21 PM

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on Novavax's COVID-19 and influenza combination vaccine, as well as its standalone influenza vaccine candidates. The hold was prompted by a serious adverse event (SAE) reported in a trial participant, which involved motor neuropathy. Following the announcement, Novavax shares experienced a significant decline, dropping by as much as 20%, with a notable 16% and 18.7% drop at different points. The clinical hold aims to address safety concerns and ensure the well-being of trial participants.