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 vaccines^6-9:

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,Quadrivalent

[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.

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 people aged 6 months and above, especially in vulnerable people and high-risk population for influenza complications, such as infants, children, senior citizens, the weak and people in influenza epidemic areas.

[THERAPEUTIC INDICATION]

This product can induce body to generate immunoreaction against influenza virus and can be used for prevention of infection caused by the influenza virus strain.

[STRENGTH]

Each package contains 0.5 mL liquid. Single dose of 0.5 mL contains 15 μg haemagglutinin per type of influenza virus strain.

[ADMINISTRATION AND DOSAGE]

1. The preferred sites for injection are the anterolateral aspect of the thigh in infants aged 6-12 months or the deltoid muscle in individuals aged 13 months and above.

2. For prophylactic vaccination during or before influenza pandemic period, children aged 6-35 months should receive 2 doses of 0.5 mL with an interval of 4 weeks; individuals aged 3 years and above should receive 1 dose of 0.5 mL. Prior to use, the vaccine should be brought to room temperature and shaken well, then administered by intramuscular injection.

[PACKAGE] Pre-filled syringe or Vial. The package unit is one syringe or Vial.

[STORAGE] Store and transport between +2°C and +8°C, and protect from light.

[SHELF LIFE] 12 months.

[DRUG APPROVAL NO.]

Pre-filled syringe presentation: GuoYaoZhunZi S20200010

Vail presentation: GuoYaoZhunZi S20217013

[MANUFACTURER] Name: 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)