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The FDA has placed Novavax’s investigational new drug (IND) applications for its combined COVID-19 and influenza vaccine (CIC) and single influenza vaccine on clinical hold. This is because serious adverse events (AEs) of motor neuropathy have been reported to have occurred. Participants in the ongoing Phase 2 trial of the CIC vaccine, completed in July 2023. 1 This patient is at a facility outside the United States and was vaccinated in January 2023. Serious adverse events were reported in September 2024.
Dr. Robert Walker, Novavax’s chief medical officer, said in a statement that the company is “working closely with the FDA to provide the necessary information to better understand this finding and resolve the clinical hold.” ”, adding that “safety is important.” This is our top priority, and although we do not believe a causal relationship with this serious adverse event has been established, we are committed to working expeditiously to respond to requests for further information from the FDA. I’m here. Our goal is to successfully resolve this issue and begin Phase 3 trials as soon as possible. ”
The company said investigators had been informed of the conduct. Existing data from previous trials of the novel coronavirus disease (COVID-19) and influenza of Novavax’s vaccine showed no signs of motor neuron impairment. In all groups in the phase 2 trial, 2 no significant adverse events were reported, and no potentially immune-mediated pathology or serious treatment-related adverse events were reported. Overall, unilateral AEs were reported in <25% of all groups, consistent with diagnoses in the elderly population. Compared with the prevalence of Fluad and Fluzone HD, local and systemic symptoms were mainly mild and moderate.
This hold does not affect the company’s standalone coronavirus vaccine IND. In Phase 2 trials, the highest dose of the single-dose coronavirus disease (COVID-19) vaccine candidate was approximately 30% higher than Novavax’s prototype coronavirus disease (COVID-19) vaccine, which was statistically significant. showed a strong anti-S immunoglobulin G reaction and neutralization reaction. This was achieved while maintaining safety and reactogenicity comparable to currently approved dose levels of nubaxovid.
According to data published in May 2023, the CIC vaccine candidate achieved both immunoglobulin G (IgG) and neutralization levels comparable to Novavax’s prototype COVID-19 vaccine (NVX-CoV2373), but multiple A similar response was achieved with a combination formulation of Good agreement with reference comparator controls for both SARS-CoV-2 and four homologous influenza strains. 2
News of this clinical hold follows the FDA’s positive announcement in August 2024 about Novavax’s updated COVID-19 vaccine. The vaccine targets the Omicron variant JN1 strain (NVX-CoV2705) and has been granted Emergency Use Authorization (EUA) for individuals 12 years of age and older. 3 The new vaccine features a monovalent component and replaces the previously approved Novavax COVID-19 vaccine (adjuvanted). (2023-2024 Formula).
Eligible people include people 12 years and older who are unvaccinated, partially vaccinated with Novavax, or have previously received a COVID-19 vaccine from another manufacturer. It will be. For the latest vaccine, two doses for unvaccinated people, one dose for people partially vaccinated with Novavax, and one dose for people fully vaccinated with previous COVID-19 vaccines. vaccination is required.
References
1. Update on Novavax’s COVID-19/influenza combination therapy and single-influenza phase 3 study. Novavax. News release. October 16, 2024. Accessed October 16, 2024. https://www.prnewswire.com/news-releases/update-on-novavaxs-covid-19-influenza-combination-and-stand-alone-influenza-phase-3 -trial-302277807.html
2. Positive Phase 2 topline results show that Novavax’s combination COVID-19 and influenza, single influenza and high-dose COVID-19 vaccine candidates are demonstrating strong immune responses. Novavax. News release. May 9, 2023. Accessed October 16, 2024. https://www.prnewswire.com/news-releases/positive-phase-2-topline-results-show-novavaxs-covid-influenza-combination-stand-alone-influenza -and-high-dose-covid-vaccine- candidates-demonstrate-robust-immune-responses-301819043.html
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