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The H5N8 MF59 vaccine (commercially known as Zoonotic Influenza Vaccine Seqirus) is an MF59-adjuvanted, inactivated zoonotic influenza vaccine developed by CSL Seqirus for active immunization against H5 subtype influenza A viruses (highly pathogenic avian influenza, HPAI) in individuals aged 6 months and older. The vaccine is based on the A/Astrakhan/3212/2020 (H5N8)-like strain (clade 2.3.4.4b) and is manufactured using an egg-based platform (with cell-culture-derived formulations also studied). It is formulated with MF59C.1, an oil-in-water squalene emulsion adjuvant that enhances and broadens the immune response. Administered as a two-dose intramuscular regimen, the vaccine received marketing authorization from the European Medicines Agency (EMA) in October 2023 (with strain updates and age extensions in 2024 and 2026) and has been utilized in pandemic preparedness stockpiles and clinical studies to provide cross-protective immunity against circulating clade 2.3.4.4b H5N1 viruses.
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