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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.
About SINOVAC
Sinovac Biotech Ltd. (SINOVAC) is a global biopharmaceutical company headquartered in China. Guided by its mission to “Supply Vaccines to Eliminate Human Diseases,” the Company is dedicated to the research, development, manufacturing and supply of vaccines and related biological products, providing vaccine products and related solutions for disease prevention and control worldwide.
SINOVAC has a diversified vaccine portfolio across multiple disease areas, including influenza, viral hepatitis, varicella, hand, foot and mouth disease (HFMD), poliomyelitis, rabies, tetanus, and pneumococcal disease. Three of SINOVAC's vaccines have been prequalified by the World Health Organization: the inactivated hepatitis A vaccine Healive®, the Sabin-strain inactivated poliomyelitis vaccine (sIPV), and the live attenuated varicella vaccine.
SINOVAC has extensive experience in vaccine research, development and commercialization for emerging infectious diseases and public health emergencies. The Company initiated vaccine R&D in response to major public health threats, including SARS, H5N1, H1N1, and COVID-19, and developed the world's first inactivated SARS vaccine (with Phase I clinical trials completed), China's first inactivated pandemic influenza vaccine against H5N1 (Panflu®), the world's first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the world's most widely used inactivated COVID-19 vaccine. Beyond its marketed portfolio, SINOVAC continues to advance its R&D pipeline, spanning combination vaccines, recombinant protein vaccines, mRNA technologies, antibody-based products, and other next-generation technologies and product platforms, while expanding its capabilities in disease prevention and biopharmaceuticals.
With a long-standing commitment to innovation and global health, SINOVAC continues to deepen collaboration with research institutions, international organizations, and local partners while expanding its global presence. Through technological collaboration, localized production, and industrial partnerships, the Company aims to improve access to high-quality vaccines across regions, better address local disease prevention and healthcare needs, and strengthen preparedness for future public health challenges.
For more information, please see the Company's website at www.sinovac.com.