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Phase IV Study of SINOVAC 23-Valent Pneumococcal Polysaccharide Vaccine Published in Vaccines
BEIJING, September 1, 2025 – SINOVAC's 23-valent pneumococcal polysaccharide vaccine (PPSV23) induces a significant immune response and maintains a favorable safety profile in individuals aged two years and older, with performance comparable to internationally marketed vaccines, according to a Phase IV study published on August 15, 2025, in the peer-reviewed journal Vaccines.
The randomized, double-blind, active-controlled clinical trial, jointly conducted by the Shaanxi Provincial Center for Disease Control and Prevention, the National Institutes for Food and Drug Control (NIFDC), and Beijing Sinovac Biological Products Co., Ltd., evaluated 1,799 volunteers aged two years and older. Participants were randomized at a 2:1 ratio to receive either SINOVAC's PPSV23 or a licensed comparator vaccine to assess the immunogenicity and safety profiles.
Key Clinical Findings:
Non-inferior Immunogenicity: On day 30 post-vaccination, seroconversion ratesfor each of the 23 serotypes ranged from 59.22% to 95.67% in the SINOVACgroup, and in the control group from 59.66% to 94.07%. All 23 serotypesevaluated in the SINOVAC group met non-inferiority standards.
Enhanced Response: SINOVAC’s PPSV23 demonstrated enhanced immune response in 12 specificserotypes: 6B, 23F, 1, 2, 4, 8, 9N, 9V, 11A, 15B, 17F, and 18C.
ComparableSafety Profile: The incidence rate of adverse reactions within30 days post-vaccination was 19.68% for the SINOVAC group and 19.67% forthe control group, showing no statistically significant difference betweenthe two cohorts.
The findings supports that SINOVAC’s PPSV23 as a safe and effective immunogenic vaccination option for the prevention of pneumococcal diseases in individuals two years and older, including children, adults, and the elderly.
The full research paper, titled "Safety and Immunogenicity of a 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23) in Chinese Children, Adults and the Elderly: A Phase 4, Randomized, Double-Blind, Active-Controlled Clinical Trial", is available at: https://doi.org/10.3390/vaccines13080866.
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.