FDA Lifts Clinical Restrictions on Novavax’s COVID-19 and Influenza Combination Vaccine
Novavax, a U.S.-based biotechnology firm, revealed that the FDA has lifted the clinical hold on its dual COVID-19-influenza combination (CIC) vaccine, along with its stand-alone influenza vaccine candidates. This hold was initially instituted on October 16, 2024.
The imposition of the clinical hold stemmed from a serious adverse event experienced by an individual participating in a Phase 2a trial, which was concluded in 2023. This event was reported as motor neuropathy.
At that time, Novavax’s Chief Medical Officer, Robert Walker, stated, “We are collaborating closely with the FDA to supply the required information that will clarify this observation and help lift the clinical hold.” He emphasized the company’s steadfast commitment to safety, asserting that they did not believe a causal link was established for the serious adverse event and were committed to expediently fulfilling the FDA’s information requests. “Our objective is to resolve this situation promptly and initiate our Phase 3 trial without delay,” he added.
After Novavax addressed the raised issues and submitted additional information, it was determined that the participant had been diagnosed with amyotrophic lateral sclerosis, a condition that is neither immune-mediated nor linked to the vaccine.
In a subsequent press release, Robert Walker expressed gratitude towards the FDA for its cooperation and thorough evaluation of the newly provided information. “The data we submitted to the FDA corroborated our conclusion that the serious adverse event wasn’t related to our vaccine,” he stated, affirming the company’s aim to begin the Phase 3 trial as soon as feasible.
Novavax’s vaccine technology utilizes the Matrix-M adjuvant platform, derived from natural compounds known as saponins, found in the bark of the Chilean Soapbark tree. These Matrix-M adjuvant particles are integral to enhancing the immune response alongside the vaccine nanoparticles.
The company will now collaborate closely with trial investigators and other relevant parties to resume clinical trials for both the CIC vaccine and the stand-alone influenza vaccine.
Other firms engaged in developing COVID-19-influenza combination vaccines include Pfizer and BioNTech, in addition to Moderna. All their Phase 3 trials continue to progress. Despite Moderna releasing positive Phase 3 results in June 2024, an update from BioNTech and Pfizer in August 2024 indicated that their COVID-19-influenza combination candidate did not satisfy one of the primary immunogenicity endpoints, revealing a weaker immune response against the influenza B strain.