Sinovac Biotech initiates clinical trial on a HFMD vaccine candidate

Sinovac Biotech (SVA) kicked off the enrollment for a Phase III clinical trial on a vaccine candidate to prevent HFMD caused by both Enterovirus 71 and Coxsackievirus 16. Notably, no multivalent vaccines against HFMD have yet been approved for marketing worldwide. The Phase III clinical trial is designed to be a multicenter, randomized, double-blind, controlled trial to evaluate the efficacy, safety and immunogenicity of this vaccine candidate in infants and young children aged 6 to 71 months. Sinovac has initiated a phase I/II clinical trial on its bivalent vaccine in China since September 2023. The results from Phase I/II clinical trial demonstrated that the vaccine candidate has favorable safety and immunogenicity.