influenza A (H5N1) monovalent vaccine, adjuvanted

The MF59-adjuvanted monovalent H5N1 pandemic influenza vaccine (brand name: Audenz, Celldemic, Incellipan; code name: aH5N1c) is a cell culture-derived, monovalent, inactivated, subunit influenza virus vaccine developed by Seqirus (a subsidiary of CSL). It is the first adjuvanted, cell-based pandemic influenza vaccine approved by the FDA (in February 2020) and is indicated for active immunization against the influenza A (H5N1) virus subtype in individuals six months of age and older. The vaccine combines two key technologies: cell-based antigen manufacturing (using Madin-Darby Canine Kidney [MDCK] cells) and Seqirus' proprietary MF59 adjuvant (an oil-in-water emulsion containing squalene). The active ingredient consists of purified hemagglutinin (HA) and neuraminidase (NA) surface antigens from an inactivated H5N1 strain (specifically A/turkey/Turkey/1/2005-like strain). The MF59 adjuvant enhances and broadens the immune response, allowing for antigen dose sparing, which is critical for rapid vaccine scale-up during a pandemic.

Brand names

AudenzCelldemicIncellipan

Other names

MF59-adjuvanted monovalent H5N1 pandemic influenza vaccineMF-59-adjuvanted monovalent H5N1 pandemic influenza vaccineMF 59-adjuvanted monovalent H5N1 pandemic influenza vaccineInfluenza A (H5N1) Monovalent Vaccine, Adjuvantedinfluenza A virus vaccine, h5n1, adjuvanted