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.
Sinovac Biotech Ltd. (SINOVAC) is a China-based biopharmaceutical company that focuses on the R&D, manufacturing, and commercialization of biomedical products that protect against human diseases.
SINOVAC's product portfolio includes vaccines against COVID-19, enterovirus 71 (EV71) infected hand-foot-mouth disease (HFMD), hepatitis A, varicella, influenza, poliomyelitis, pneumococcal disease, mumps, etc.
The COVID-19 vaccine, CoronaVac®, has been approved for use in more than 60 countries and regions worldwide. The hepatitis A vaccine, Healive®, passed WHO prequalification requirements in 2017. The EV71 vaccine, Inlive®, is an innovative vaccine under "Category 1 Preventative Biological Products" and commercialized in China in 2016. In 2022, SINOVAC's Sabin-strain inactivated polio vaccine (sIPV) and varicella vaccine were prequalified by the WHO.
SINOVAC was the first company to be granted approval for its H1N1 influenza vaccine Panflu.1®, which has supplied the Chinese government's vaccination campaign and stockpiling program. The Company is also the only supplier of the H5N1 pandemic influenza vaccine, Panflu®, to the Chinese government stockpiling program.
SINOVAC continually dedicates itself to pipeline development including but not limited to new technology, new vaccines as well as other biomedical products. We will constantly explore global opportunities of strategic expansion.
For more information, please visit the Company’s website at www.sinovac.com.
Sinovac Biotech Ltd.