SINOVAC's Varicella Vaccine Approved for Registration in Indonesia
BEIJING, Nov. 7, 2025 — Sinovac Biotech Ltd. ("SINOVAC" or the "Company"), a leading global provider of biopharmaceutical products, today announced that its live attenuated varicella vaccine, produced by SINOVAC (Dalian) Vaccine Technology Co., Ltd., has been granted marketing authorization by the Indonesian authorities (BPOM). To date, the vaccine has received regulatory approvals in multiple international markets, including Indonesia, Argentina, Peru, and Lebanon.
As the first and currently only varicella vaccine from China to receive World Health Organization (WHO) Prequalification, the product has been distributed to nearly 20 countries and regions, with cumulative global shipments exceeding 20 million doses.
The SINOVAC varicella vaccine is developed using the proprietary human diploid cell line (SV-1) and manufactured under B+A grade cleanliness standards. The formulation is notably free of antibiotics, gelatin, and human serum albumin, minimizing the risk of potential allergic reactions. Additionally, the vaccine is designed with an osmotic pressure profile similar to human fluids, which has been shown to reduce injection-site pain and localized adverse reactions.
A recent head-to-head clinical study comparing SINOVAC's vaccine with another WHO-prequalified international varicella vaccine demonstrated that SINOVAC's candidate met the non-inferiority criteria for immunogenicity. Furthermore, the study reported a superior safety profile compared to the control group. These findings strengthen the evidence-based clinical framework supporting the vaccine's global application and provide robust data for public health decision-making.
The approval in Indonesia a market with rigorous quality standards and specific Halal compliance requirements underscores SINOVAC's comprehensive capabilities in process control, quality management, and religious compliance. This milestone further expands SINOVAC's international footprint and contributes to the global supply of high-quality varicella vaccines, intended to reduce the public health burden of associated infectious diseases worldwide.
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.
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