The FDA has removed the clinical hold on Novavax's Investigational New Drug Application, clearing the way for Phase III trials of its COVID-19-influenza Combination (CIC) vaccine and standalone influenza vaccine to proceed. This decision follows the FDA's review of additional information provided by Novavax, which addressed concerns related to a serious adverse event reported in a previous trial.
Clinical Hold Resolution
The clinical hold was initially implemented due to a report of motor neuropathy in a participant from a Phase II trial. Subsequent investigation and reclassification of the event as amyotrophic lateral sclerosis, deemed unrelated to the vaccine, led the FDA to reverse its decision. According to Robert Walker, MD, chief medical officer of Novavax, the company provided data supporting the assessment that the adverse event was not linked to their vaccine.
Vaccine Technology and Trial Design
The Phase III trials will evaluate vaccines incorporating Novavax’s Matrix-M adjuvant technology. This adjuvant, derived from saponins found in the bark of the Quillaja Saponaria tree, is designed to enhance the immune system's response to the vaccine's protein nanoparticles. Novavax reports that its Matrix-M adjuvant has been well-tolerated in approximately 50,000 patients across Phase I-III studies.
Current Respiratory Disease Landscape
Recent data from the Centers for Disease Control and Prevention (CDC) indicates that influenza cases increased by 1.3% in the week ending November 2, 2024, with outpatient visits for respiratory illnesses rising by 2.4%. While overall influenza activity remains low, a slight increase in pediatric cases has been noted. Simultaneously, COVID-19 positivity rates stood at 4.8%, a 5.2% increase from the prior two weeks, while emergency department visits related to COVID-19 decreased by 12%, and the death rate decreased by 9.1%.
Novavax is now working with trial investigators to resume recruitment for the Phase III trials as quickly as possible.
