Novavax announces positive phase 2 results for COVID-19/influenza vaccine candidates

11 May 2023
www.pmlive.com
VaccineClinical ResultPhase 2Phase 1mRNA
Novavax announces positive phase 2 results for COVID-19/influenza vaccine candidates
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Source: PMLiVE
Novavax has announced positive phase 2 results for its COVID-19/influenza combination (CIC), stand-alone influenza and high-dose COVID-19 vaccineCOVID-19 vaccine candidates.
According to the topline results released by the company, all three candidates showed a ‘reassuring’ preliminary safety profile, as well as 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 homologous influenza strains that were comparable to the reference comparators.
For the stand-alone influenza vaccine candidate, haemagglutination inhibition (HAI) antibody responses were 31% to 56% higher for all four strains compared to Fluad, and 44% to 89% higher for A strains compared to Fluzone HD.
The highest dose stand-alone COVID-19 vaccineCOVID-19 vaccine candidate achieved statistically significant anti-S IgG and neutralising responses approximately 30% higher than Novavax's prototype COVID-19 vaccineCOVID-19 vaccine, while maintaining comparable safety and reactogenicity to the currently authorised dose level of the company's Nuvaxovid.
All three vaccine candidates contain Novavax's patented Matrix-M adjuvant, which the company says ‘enhances the immune system response, making it broader, and more durable’.
Filip Dubovsky, president, research and development 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 data we 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.
In November 2022, Pfizer and BioNTech also initiated a phase 1 study of their mRNA-based combination COVID-19/influenza vaccine.
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