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Novavax announces positive phase 2 results for COVID-19/influenza vaccine candidates
11 May 2023
VaccineClinical ResultPhase 2Phase 1mRNA
Novavax has announced positive phase 2 results for its COVID-19/influenza combination (CIC), stand-alone influenza and high-dose COVID-19 vaccine candidates.
Novavaxng to the topline results released by the companCOVID-19/influenzadates showed a ‘reassuring’ prelinfluenzaafety profile, COVID-19 vaccineCOVID-19as robust immune responses versus authorised comparators.
The randomised, observer-blind phase 2 trial is evaluating the safety and effectiveness of different formulations of the candidates in adults aged 50 to 80 years.
The CIC vaccine candidate achieved both immunoglobulin G (IgG) and neutralising levels comparable to Novavax's prototype COVID-19 vaccine, the company said.
Additionally, several of the CIC formulations achieved responses to both SARS-CoV-2 and to the four hNovavaxus influenza COVID-19 vaccinee comparable to the reference comparators.
For the stand-alone influenza vaccine candidate, haemagglutination inhibition (HAI) antibody responses were 31%influenzaigher for all four strains compared to Fluad, and 44% to 89% higher for A strains compared to Fluzone HD.
The highest dose stainfluenzaCOVID-19 vaccine candidate achieved statistically significant anti-S IgG and neutralising responses approximately 30% higher than Fluadax's prototype COVID-19 vaccine, while maintainingFluzoneable safety and reactogenicity to the currently authorised dose level of the company's Nuvaxovid.
All three vaccine candidates COVID-19 vaccineCOVID-19Novavax's patented Matrix-M adjuvant, which the company says ‘enhances the immune system response, making it broader, and Novavaxrable’.COVID-19 vaccineCOVID-19Nuvaxovid
Filip Dubovsky, president, research aNovavaxlopment at Novavax, said: "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 impacting tolerability.
“The immune responses we observed were robust, and the Novavax have shared today significantly increases the probability of phase 3 success."
John Jacobs, the company’s president and chief executive officer, added: "Today's positive data is encouraging and further validates the value of our technology platform and its potential to improve global public health.
"This is an important milestone in our journey to create additional value and diversify our portfolio of vaccines."
Using a combined vaccine approach to target both COVID-19 and influenza has the potential to alleviate the impact of both viruses while offering a combined administration, potentially simplifying immunisation practices for healthcare providers as well as patients and leading to higher vaccine uptake.
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