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Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted is a two-component vaccine consisting of an H5N1 immunizing antigen (as a suspension) and an AS03 adjuvant (as an oil-in-water emulsion). The vaccine is prepared by combining the H5N1 antigen suspension with the AS03 adjuvant emulsion. The H5N1 antigen is derived from virus grown in eggs, which is inactivated with ultraviolet light followed by formaldehyde treatment, purified by centrifugation, and disrupted with sodium deoxycholate. The AS03 adjuvant system enhances the vaccine-induced immune response and contains DL-α-tocopherol (vitamin E), squalene, and polysorbate 80 in an oil-in-water emulsion. This adjuvant system activates multiple innate immune pathways including interferon and JAK-STAT signaling, Fcγ receptor-mediated phagocytosis, and antigen processing and presentation, which leads to superior adaptive responses against the vaccine antigen.
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