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, which was announced on October 16, 2024, stemmed from a spontaneous report of a serious adverse event in a participant who received the investigational CIC vaccine during a Phase 2 trial completed in 2023. The FDA requested additional information regarding the event, initially reported as motor neuropathy.
Investigation Details
Following a thorough review of the provided data, the FDA concluded that Novavax had satisfactorily addressed all clinical hold issues. The additional information 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 event was ultimately assessed as unrelated to the vaccination.
Company Statement
"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."
About the Vaccine Candidates
Novavax's COVID-19-Influenza Combination (CIC) vaccine candidate aims to provide protection against both COVID-19 and influenza in a single dose. The vaccine utilizes Novavax's recombinant protein approach, innovative nanoparticle technology, and patented Matrix-M adjuvant to enhance the immune response. The stand-alone influenza vaccine candidate is designed to offer similar protection against various influenza strains.
Phase 3 Trial Plans
Novavax will be working closely with clinical trial investigators and other partners to resume trial activities for the Phase 3 trial as quickly as possible. Further details regarding the trial design, endpoints, and patient population will be disclosed in subsequent announcements.
