US firm Novavax informed on September 8, 2021 that it has started early stage trial to evaluate the safety and immunogenicity of combined seasonal influenza and COVID-19 vaccines.
The trial will be conducted on 640 healthy adults between the age of 50-70 years and will be conducted in Australia.
All the trial participants will be those who have either been previously infected with the coronavirus or given an authorized COVID-19 vaccine at least eight weeks prior to the study.
Combined vaccine trial: Key Details
The clinical trial will be conducted of Novavax's recombinant protein-based COVID-19 vaccine NVX-CoV2373 and NanoFlu™ vaccine candidates and saponin-based Matrix-M adjuvant in a single formulation (COVID-NanoFlu Combination Vaccine).
Novavax COVID-19 vaccine, NVX-CoV2373 and and NanoFlu have previously demonstrated strong results as standalone vaccines in Phase 3 clinical trials.
The combined vaccine trials are expected to be launched by the end of 2021.
Significance
According to Novavax's President of Research and Development, Gregory M. Glenn, " This study is the first-of-its-kind to evaluate the vaccine's potential to induce a robust immune response, augmented by our Matrix-M adjuvant, against two life-threatening diseases simultaneously."
He added saying that the combination of these two vaccines, which have individually delivered outstanding results when its comes to safety, may lead to greater efficiencies for the healthcare system and achieve high levels of protection against COVID-19 and influenza with a single regimen.
Novavax's COVID-19 Vaccine shows 90.4% efficacy•Novavax's COVID-19 Vaccine demonstrated 90.4% efficacy in preventing symptomatic COVID-19, as per the •Phase 3 clinical trial that was conducted on 29,960 adult volunteers in the United States and Mexico. The vaccine trials showed 100% protection against moderate and severe disease. •It also showed 91.0% efficacy in preventing symptomatic COVID-19 disease among those who are at high risk of developing complications from COVID-19, people above 65 years and people under 65 years with certain comorbidities or with likely regular exposure to COVID-19. •The safety data from the trials indicate that the investigational vaccine was generally well-tolerated. •The most common symptoms after the vaccine shot was mild-to-moderate injection site pain and tenderness along with fatigue, headache and muscle pain lasting less than two days. |
COVID-NanoFlu Combination Vaccine
The COVID-NanoFlu Combination Vaccine had also demonstrated robust, functional immune responses to each component of the quadrivalent influenza vaccine and the SARS-CoV-2 spike protein with Matrix-M adjuvant playing a key role in preclinical studies.
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