Novavax has announced that its covid-Influenza Combination (CIC) vaccine candidates, a combination of the stand-alone flu vaccine and the high-dose covid-19 vaccinehave shown a “reassuring” preliminary safety profile as well as comparable reactogenicity to Novavax’s individual influenza and Covid vaccine candidates or licensed comparator influenza vaccines.
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The primary endpoint evaluated the safety of different formulations of the CIC vaccine candidate and quadrivalent influenza vaccine candidate compared to Fluad and Fluzone High-Dose Quadrivalent (Fluzone HD), as well as a High-dose Covid candidate vaccine in adults 50 to 80 years of age.
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All three candidate vaccines contained Novavax’s proprietary Matrix-M adjuvant and showed preliminary safety profiles. and reassuring reactogenicity, comparable to those of ‘Fluad’ and ‘Fluzone HD’. The reactogenicity profile remained constant as the dose of adjuvant or antigen was increased.
There were no adverse events of particular interest, no potentially immune-mediated medical conditions, and no serious treatment-related events in all groups.
Unsolicited adverse effects occurred in 25 percent or fewer of any group and were consistent with diagnoses in the older adult population. Local and systemic symptoms were mostly mild to moderate and occurred at rates comparable to ‘Fluad’ and ‘Fluzone HD’.
“The reactogenicity results support our previous observations that this technology is well suited for combination vaccines because large amounts of antigen can be incorporated without affecting tolerability,” said Novavax President of Research and Development Filip Dubovsky. . “The immune responses we observed were robust, and the data we have shared today significantly increases the likelihood of Phase 3 success,” he added.
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The candidate CIC vaccine achieved immunoglobulin G (IgG) and neutralization levels comparable to those of Novavax’s prototype covid vaccine. In addition, several of the combined formulations achieved responses against Sars-CoV-2. and to the four homologous influenza strains comparable to those of the reference comparators, supporting their prioritization for advanced development.
The stand-alone influenza vaccine candidate achieved statistically significant haemagglutination inhibition (HAI) antibody responses, 31 to 56 percent higher for all four strains compared to Fluad. Titers were 44 percent (H1N1) to 89 percent (H3N2) higher for A strains and statistically non-inferior for B strains compared to Fluzone HD.
The highest dose of the covid vaccine candidate achieved statistically significant anti-S IgG and neutralization responses, about 30 percent higher than those of Novavax’s prototype Covid vaccine, while maintaining comparable safety and reactogenicity to the currently licensed dose level of Nuvaxovid.
“Today’s positive data is encouraging and further validates the value of our technology platform and its potential to improve global public health,” said Novavax President and CEO John C. Jacobs. “This is an important milestone on our journey to create additional value and diversify our vaccine portfolio.”
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2023-05-10 18:06:26
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