SINOVAC Begins Phase I Trials of Bivalent Enterovirus Vaccine

Vaccine is First to Target Both EV71 and CA16 Viruses, Boosting HFMD Prevention

September 21, 2023, Beijing, China – Sinovac Biotech Ltd. ("SINOVAC" or the "Company") (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced that the Company has initiated Phase I clinical trials of its bivalent enterovirus inactivated vaccine, which aims to protect against hand, foot and mouth disease (HFMD) caused by Enterovirus 71 (EV71) and Coxsackievirus 16 (CA16).

The clinical trials mark the first for this type of vaccine in China, which was approved in July 2023. The Phase I studies, held in Yunnan Province, have two parts: an open-label group involving 36 adults aged 18 to 59 years and 36 children aged 6 to 12 years; and a randomized, double-blinded, positive-control group of 72 children aged 6 to 71 months, to evaluate the safety and immunogenicity of this vaccine.

A lack of specific antiviral drugs makes vaccination one of the most effective weapons in the prevention of HFMD, a common childhood infection that can lead to serious complications. SINOVAC's inactivated EV71 vaccine, Inlive^®, which boasts a protective efficacy of 94.6% against EV71-associated diseases¹, was approved in China at the end of 2015. Since then, the HFMD cases from EV71 infections have dropped significantly in China, reducing the risk of severe illness and death.

Recognizing its efficacy, Indonesia also approved Inlive^® for market use in children aged 6 months to 3 years in November 2022.

However, the diverse nature of enteroviruses and limited cross-immunity means HFMD caused by CA16 remains challenging. As a result, there is a medical need for a multivalent vaccine that can provide more comprehensive protection against the disease.

Reference:

[1] Fengcai Zhu, Wenbo Xu, Jielai Xia, et al. Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China [J]. N Engl J Med, 2014 Feb 27;370(9):818-28.