Novavax, a biotech company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced the initiation of a phase 2 trial for two new vaccine candidates: a combined COVID and flu vaccine, and a stand-alone influenza vaccine.
The COVID-19-Influenza Combination (CIC) and influenza vaccine candidates will be evaluated for safety and efficacy (immunogenicity) in individuals aged 50 to 80.
“We’re encouraged by the initiation of this trial given the positive results shared earlier this year from our phase 1/2 trial, the first of its kind to evaluate a combined COVID-19 and influenza vaccine,” said Stanley C. Erck, President and Chief Executive Officer of Novavax.
“We believe that like influenza, COVID-19 will also be seasonal moving forward, and that there is room in the market for new alternatives to provide better protection against the impact of influenza, particularly in older adults, and to explore the potential to combine this with protection from COVID.”
The quadrivalent influenza vaccine candidate from Novavax, the recombinant protein-based COVID-19 vaccine (NVX-CoV2373), and the patented saponin-based Matrix-MTM adjuvant will all be evaluated in the randomized, observer-blinded experiment.
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.
The Novavax adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
One of the main goals of this study is to assess the safety, tolerability, and immunological responses to various formulations of the CIC and influenza vaccine candidates.
According to the company, over 2,300 participants will be enrolled in the phase 2 dose-confirmation trial over two phases at various sites in Australia and New Zealand.
Initial trial findings are anticipated in the middle of 2023.
FDA granted EUA for the CoV2373
Earlier in 2022, Bio.News reported that the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Novavax COVID-19 vaccine Adjuvanted (NVX-CoV2373) “for the prevention of Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 17 years of age.”
“This authorization follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by the FDA,” said the agency’s roundup.
Novavax is a member of the Biotechnology Innovation Organization (BIO).