Sinovac Biotech Ltd. (“SINOVAC” or the “Company”) (NASDAQ: SVA), a leading biopharmaceutical provider in China, has announced the initiation of a Phase III clinical trial for its bivalent vaccine candidate, designed to prevent Hand, Foot, and Mouth Disease (HFMD) caused by Enterovirus 71 (EV71) and Coxsackievirus A16 (CA16). This marks a significant step forward, as no multivalent HFMD vaccines have been approved for marketing worldwide.
The Phase III clinical trial is a multicenter, randomized, double-blind, controlled study aimed at evaluating the vaccine’s efficacy, safety, and immunogenicity in infants and young children aged 6 to 71 months. This follows the initiation of a Phase I/II clinical trial in China in September 2023, where the bivalent vaccine candidate demonstrated favorable safety and immunogenicity results.
HFMD is caused by a group of enteroviruses, and many of these viruses have low cross-immunogenicity, meaning immunity to one may not provide protection against others. The disease predominantly affects children under 5 years old, who account for over 90% of HFMD cases. Given the insufficient protection provided by existing vaccines, SINOVAC has focused on developing multivalent vaccines that offer broader protection against the most common enterovirus strains.
In line with this mission, SINOVAC has also developed the world’s first tetravalent enterovirus inactivated vaccine, which recently received approval for clinical trials. This vaccine targets HFMD caused by four virus types: EV71, CA16, CA10, and CA6. The Company aims to provide comprehensive protection for children by advancing both its bivalent and tetravalent vaccine candidates through clinical trials and eventual market availability.
SINOVAC is dedicated to advancing clinical research in collaboration with partners, with the goal of delivering effective vaccines to prevent HFMD and other enterovirus infections in children. The company’s innovative work in vaccine development is part of its broader commitment to addressing global health challenges and ensuring a safer future for children worldwide.
About SINOVAC: Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company specializing in the R&D, manufacturing, and commercialization of vaccines to protect against human infectious diseases. SINOVAC’s product portfolio includes vaccines for COVID-19, hepatitis A, enterovirus 71 (EV71)-related HFMD, varicella, influenza, polio, pneumococcal disease, and mumps.
SINOVAC’s COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries. The hepatitis A vaccine, Healive®, received WHO prequalification in 2017, and the EV71 vaccine, Inlive®, was commercialized in China in 2016. In 2022, SINOVAC’s Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.
The company is also the sole supplier of the H5N1 pandemic influenza vaccine to the Chinese government’s stockpiling program. SINOVAC continues to innovate and expand its vaccine offerings, constantly exploring global opportunities for strategic expansion in the biopharmaceutical sector.
