Novavax yesterday announced that the US Food and Drug Administration (FDA) has released a clinical hold on its new drug application for its COVID-flu combination and standalone flu vaccines. In a statement, the company said the step paves the way for it to begin enrolling participants for a phase 3 trial.
The FDA announced the clinical hold on October 16, following a report of a serious adverse event in a participant who received the combination vaccine as part of a phase 2 trial that wrapped up in 2023. The event was initially reported as motor neuropathy, which was later defined as amyotrophic lateral sclerosis (ALS), a condition not known to be immune-mediated or associated with vaccination. The FDA concluded that the event was not related to the vaccine.
Robert Walker, MD, chief medical officer at Novavax, thanked the FDA for its thorough review of additional information it submitted to the agency. "The information provided to the FDA supported our assessment that the serious adverse event was not related to our vaccine. We plan to start our Phase 3 trial as soon as possible."
The candidate vaccines are part of Novavax's portfolio of recombinant protein-based vaccines that use nanoparticle technology and the company's Matrix M adjuvant to boost the immune response.