Influenza Vaccine Portfolio
Trusted worldwide, with over 120 million doses administered worldwide，and robust scientific evidence supporting safety and immunogenicity.
Anflu®：China's first preservative-free split-virion influenza vaccine
Panflu®：China's first pandemic influenza A (H5N1) vaccine
Panflu.1®：The world's first influenza A (H1N1) vaccine and the first to be used in large-scale vaccination.
TetrAnflu：A quadrivalent influenza vaccine providing broader protection for individuals aged 6 months and older.
Extensive Use Across Multiple Countries
Building on comprehensive influenza vaccine portfolio, SINOVAC's influenza vaccines have been widely used in large-scale vaccination, with over 100 million doses administered across nearly 20 countries and regions.1
Stringent Quality Control Standards
Preservative-free formulation，with limits for endotoxins, formaldehyde, and ovalbumin set more stringently than those specified in the Chinese Pharmacopoeia (ChP) and the European Pharmacopoeia (Ph. Eur.) 2-3
Internal quality control testing covers approximately twice the number of parameters specified in the Chinese Pharmacopoeia (ChP) 2-4
A purification process protected under a China-issued patent is used to ensure high product purity.5
Robust Immunogenicity and Saftety Supported by Scientific Evidence
Multiple clinical studies have demonstrated the immunogenicity and safety of SINOVAC's influenza vaccines6-9:
Phase III international multi center clinical study: The immunogenicity was non-inferior to that of a comparator quadrivalent influenza vaccine (QIV), with a comparable safety profile.6
Phase III clinical study in China: High seroprotection rates were observed across studied populations, with values reaching up to 99.4%.7
Highlights of Prescribing Information
[NAME OF THE MEDICINAL PRODUCT]
Generic Name: Influenza Vaccine (Split Virion), Inactivated
[COMPOSITION AND DESCRIPTION]
This product is derived from the influenza virus recommended by WHO, which is cultured in chicken embryo, followed by harvest, inactivation, purification and disruption. Finally, a slightly opalescent liquid is obtained. This vaccine contains no preservatives.
Active ingredients: For haemagglutinins of prevalent strains of influenza virus in current year. Excipients include sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate.
[TARGET GROUPS FOR VACCINATION]
The vaccine is approved for use in individuals aged 6 months and older, particularly those who are vulnerable to influenza or at increased risk of influenza-related complications, including infants, children, older adults, and individuals living in areas with influenza activity.
[THERAPEUTIC INDICATION]
The vaccine induces an immune response against influenza viruses following vaccination and is indicated for the prevention of influenza caused by the influenza virus strains included in the vaccine
[STRENGTH]
0.5 mL/dose. Single dose of 0.5 mL contains 15 ug haemagglutinin per strain.
[ADMINISTRATION AND DOSAGE]
Vaccination should be administered in accordance with the locally approved dosage regimen.
[PACKAGE] Vial. Pack size of 1 vial or 50 vials.
Pre-filled syringe. The package unit is 1 syringe, 10 syringes or 50 syringes.
[STORAGE] Store and transport between +2°C and +8°C, and protect from light.
[SHELF LIFE] 12 months.
[DRUG APPROVAL NO.]
GuoYaoZhunZi S20053056
[MANUFACTURER] SINOVAC BIOTECH CO., LTD.
[ADVERSE REACTIONS][CONTRAINDICATION] [PRECAUTIONS] [DRUG-DRUG INTERACTIONS][MEDICATION FOR PREGNANT AND LACTATING WOMEN] and other detailed information, please refer to the Product Insert.
Reference
[1] SINOVAC's Influenza Vaccines: Global Cumulative Administration Data Summary (2006 – December 2025)
[2] National Pharmacopoeia Commission. Pharmacopoeia of the People's Republic of China [M]. Beijing: China Medical Science Press, 2025.
[3] European Pharmacopoeia (Ph. Eur.) https://www.edqm.eu/en/european-pharmacopoeia
[4] Sinovac Biotech Co.,Ltd. Product Registration Standard for Quadrivalent Influenza Virus Split Vaccine
[5] Sinovac Biotech Co.,Ltd.，Purification Methods for Influenza Virus Split Vaccine.201310681952.X[P].2016-12-07.
[6] Yang W, González PA, Xin Q, et al. Immunogenicity and Safety of a Quadrivalent Influenza Vaccine in Population Aged 3 Years and Older in Chile and the Philippines: A Phase 3, Non-Inferiority, Double-Blind, Randomized Controlled Clinical Trial. Vaccines. 2024; 12(8):892. https://doi.org/10.3390/vaccines12080892.
[7] Kai Chu, Kangwei Xu, Rong Tang,et al. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine: A randomized, double-blind, controlled phase III study in healthy population aged 3 years. Vaccine. 2020;38 :5940–5946.
[8] Quadrivalent Influenza Virus Split Vaccine, Anflu® Post-Marketing Safety Data Summary Report (2023)
[9] Zhang Lina ,Li Keli ,Li Yan ,et al.Surveillance of adverse events following immunization in China, 2023[J].CHINESE JOURNAL OF VACCINES AND IMMUNIZATION,2025,31(02):121-131.
(For Reference Only by Medical and Pharmaceutical Professionals)
EN
