The Food and Drug Administration (FDA) has approved a multidose vial presentation of Audenz (influenza A [H5N1] monovalent vaccine) for active immunization for the prevention of disease in patients 6 months of age and older at increased risk of exposure to the influenza A(H5N1) virus subtype in the event of a pandemic.
Audenz is an inactivated cell-based influenza vaccine that contains MF59, a proprietary adjuvant expected to enhance and prolong immune responses. The vaccine is administered intramuscularly as a 2-dose regimen (0.5mL each), 21 days apart.
Audenz is supplied in a carton containing 25 multidose vials; each 5mL vial contains 10 doses. It is also supplied in a carton containing 10 single-dose prefilled syringes.
“Producing Audenz in multidose vials allows for increased speed and efficiency, which is absolutely critical to help protect public health in the case of an influenza pandemic,” said Marc Lacey, Executive Director, Pandemic Response Solutions, Seqirus. “According to the CDC, the influenza A(H5N1) virus is highly pathogenic and has high pandemic potential, so it’s critical to be prepared.”
In 2020, the FDA approved Audenz in a single-dose, prefilled syringe presentation as part of the Company’s pandemic preparedness efforts in partnership with the Biomedical Advanced Research and Development Authority (BARDA). The approval was based on data from a phase 3 trial (ClinicalTrials.gov Identifier: NCT02839330) evaluating the efficacy and safety of Audenz in 3196 adults 18 years of age and older. Additionally, results from an observer-blind multicenter study involving 289 individuals 6 months through 17 years of age supported accelerated approval in this population.
- Seqirus announces US FDA approval for multi-dose vial presentation of first-ever adjuvanted, cell-based pandemic influenza vaccine. News release. Seqirus. Accessed November 23, 2021. https://www.prnewswire.com/news-releases/seqirus-announces-us-fda-approval-for-multi-dose-vial-presentation-of-first-ever-adjuvanted-cell-based-pandemic-influenza-vaccine-301430826.html.
- Audenz. Package insert. Seqirus; 2021. Accessed November 23, 2021. https://www.fda.gov/media/135020/download.