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SINOVAC's Healive® Maintains Three-Decade-Long Immunity in 15-Year Study
June 30, 2023, Beijing, China – Sinovac Biotech Ltd. ("SINOVAC" or the "Company") (NASDAQ: SVA), a leading provider of biopharmaceutical products in China, today announced promising findings from a 15-year study on the efficacy of its hepatitis A vaccine, Healive®. The findings confirm Healive® maintains a seroconversion rate of 97.9% at 15 years post-vaccination, as well as predicts long-lasting immunity exceeding three decades, providing robust evidence-based support for the administration of hepatitis A vaccines and continued development of immunization strategies.
Healive® is the first and only hepatitis A vaccine from China prequalified by the World Health Organization. To date, over 100 million doses have been administrated in more than 30 countries and regions.
The study, recently published in Human Vaccines & Immunotherapeutics, followed a cohort of 400 children aged 1 to 8 years. Subjects randomly received either two doses of Healive® or a control vaccine at 0 and 6 months. Follow-up visits, conducted at various intervals, including 1 month, 6 months, 7 months, 2 years, 3 years, 4 years, 5 years, 8 years, 11 years, and 15 years, and provided data and insights into the long-term durability of participants’ immunity.
The results underscored Healive’s® superior immunogenicity and higher seroprotection, with statistically significant advantages compared to the control group. The Healive® group exhibited an average antibody level of 164.8 mIU per milliliter, surpassing the control group’s 105.7 mIU per milliliter. Additionally, Healive® achieved a 97.9% seroprotection rate, outperforming the control group’s 94.7% rate of protection.
The study confirms Healive®-induced immunogenicity lasts over 30 years, removing the need for a booster dose. In contrast, the control vaccine is estimated to offer protection for a minimum of 25 years.
With the publication of five SCI papers and two prominent Chinese journal articles, this long-term cohort study has gained significant recognition worldwide as a valuable resource providing robust scientific evidence for hepatitis A prevention and control in China.
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.