Novavax, Inc. announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) application for its COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates, paving the way for the initiation of a Phase 3 trial. The FDA's decision follows a review of additional information provided by Novavax regarding a serious adverse event reported in a Phase 2 trial.
The clinical hold, initially announced on October 16, 2024, stemmed from a spontaneous report of a serious adverse event in a participant who received the investigational CIC vaccine in a Phase 2 trial completed in 2023. The FDA requested additional information on the event, initially reported as motor neuropathy.
Addressing the Clinical Hold
According to Novavax, the additional information provided to the FDA included a change in the event term to amyotrophic lateral sclerosis (ALS), a condition not known to be immune-mediated or associated with vaccination. The company's assessment concluded that the event was not related to the vaccination.
"We thank the FDA for their partnership and thorough review of the additional information provided as part of our response package," said Robert Walker, MD, Chief Medical Officer, Novavax. "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."
Plans for Phase 3 Trial
With the clinical hold lifted, Novavax plans to collaborate with clinical trial investigators and partners to resume trial activities for the Phase 3 trial. The trial will evaluate the safety and efficacy of the COVID-19-Influenza Combination (CIC) vaccine and stand-alone influenza vaccine candidates.
Novavax's vaccine platform combines a recombinant protein approach, innovative nanoparticle technology, and Novavax's patented Matrix-M adjuvant to enhance the immune response. The company's portfolio includes its COVID-19 vaccine and its pipeline includes its CIC and stand-alone influenza vaccine candidates. In addition, Novavax's adjuvant is included in the University of Oxford and Serum Institute of India's R21/Matrix-M malaria vaccine.
