Hand, Foot, and Mouth Disease Bivalent Vaccine Candidate Conducts Phase 3 Study

Sinovac Biotech Ltd. today announced the enrollment for a Phase Ⅲ clinical trial on a bivalent vaccine candidate to prevent Hand, Foot, and Mouth Disease (HFMD) caused by both Enterovirus 71 (EV71) and Coxsackievirus 16 (CA16).

As of December 16, 2024, no multivalent vaccines against HFMD have been approved for marketing worldwide.

SINOVAC is also developing a vaccine to prevent HFMD caused by EV71, CA16, CA10, and CA6.

According to the U.S. CDC, non-polio enteroviruses cause about 10 to 15 million infections and tens of thousands of hospitalizations each year in the United States.

HFMD can be caused by several enteroviruses, which often exhibit low cross-immunogenicity, leading to insufficient protection. HFMD is very contagious and mainly affects children under 5 years old, accounting for at least 90% of the total HFMD patients. Most people recover on their own in 7 to 10 days.