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The EV71-CA16 bivalent inactivated hand-foot-mouth disease vaccine is a prophylactic biologic developed by Aim Kanghuai Biopharmaceutical (a subsidiary of Aim Vaccine) for the prevention of hand-foot-mouth disease (HFMD). Unlike monovalent vaccines that only target Enterovirus 71 (EV71), this bivalent candidate targets both EV71 and Coxsackievirus A16 (CA16), which are the two most common pathogens associated with HFMD outbreaks. The vaccine is produced using human diploid cell culture technology and is formulated as an inactivated virus preparation. It is currently being evaluated in Phase I clinical trials in China, utilizing an intradermal administration route to assess safety and immunogenicity in both children and adults.
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