Novavax, Inc. (Nasdaq: NVAX) 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. This decision allows the company to proceed with enrolling participants in the planned Phase 3 trial. The clinical hold was initially announced on October 16, 2024, following 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 had requested additional information regarding the adverse event, which was initially reported as motor neuropathy. After a thorough review, the event was reclassified 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 Novavax vaccine.
Resumption of Phase 3 Trial
"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."
Novavax is now working with clinical trial investigators and partners to resume trial activities. The Phase 3 trial will evaluate the safety and efficacy of the COVID-19-Influenza Combination (CIC) vaccine and the stand-alone influenza vaccine.
Novavax's Vaccine Technology
Novavax utilizes a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology, and Novavax's patented Matrix-M adjuvant to enhance the immune response. This technology is also used in the University of Oxford and Serum Institute of India's R21/Matrix-M malaria vaccine.
