Sinovac Biotech Ltd. has commenced enrollment for a Phase III clinical trial of its bivalent vaccine candidate designed to prevent Hand Foot and Mouth Disease (HFMD). This trial marks a significant step as the first Phase III study of a multivalent HFMD vaccine worldwide, targeting both Enterovirus 71 (EV71) and Coxsackievirus 16 (CA16).
The Phase III trial is structured as a multicenter, randomized, double-blind, controlled study. It aims to evaluate the efficacy, safety, and immunogenicity of the bivalent vaccine in infants and young children aged 6 to 71 months. This age group is particularly vulnerable to HFMD, with children under 5 years old accounting for approximately 90% of total HFMD cases.
Prior Clinical Data
Sinovac previously conducted Phase I/II clinical trials on the bivalent vaccine in China, starting in September 2023. The data from these earlier trials indicated that the vaccine candidate demonstrated a favorable safety profile and promising immunogenicity.
Addressing HFMD with Multivalent Approach
HFMD is caused by a variety of enteroviruses, which often exhibit limited cross-immunogenicity, leading to incomplete protection. Sinovac's commitment to developing multivalent vaccines aims to provide broader protection against the dominant virus types responsible for HFMD. In addition to the bivalent vaccine, Sinovac has developed a tetravalent enterovirus inactivated vaccine, recently approved for clinical trials, which targets EV71, CA16, CA10, and CA6.
SINOVAC's Broader Portfolio
Sinovac Biotech Ltd. is a biopharmaceutical company based in China, focused on the research, development, manufacturing, and commercialization of vaccines and other biomedical products for infectious diseases. Its product portfolio includes vaccines against COVID-19 (CoronaVac®), hepatitis A (Healive®), varicella, influenza, poliomyelitis, and other diseases. Sinovac's EV71 vaccine, Inlive®, was commercialized in China in 2016.
Future Directions
Sinovac intends to collaborate with partners to further advance the clinical research of both its bivalent and tetravalent enterovirus inactivated vaccines. The company's goal is to expedite the availability of these vaccines to the market, providing comprehensive protection for children against HFMD.
