The 23-valent pneumococcal polysaccharide vaccine (PPV23) is the first bacterial vaccine product developed by Sinovac, approved for marketing in China on December 2, 2020 (NMPA Approval No. S20200027). Its quality is stringently controlled in accordance with the European Pharmacopoeia and WHO guidelines. It is designed to provide broad protection against 23 common pathogenic serotypes for individuals aged 2 and above who are at increased risk of pneumococcal infection, particularly key populations such as the elderly and those with chronic diseases, to prevent pneumococcal invasive diseases.

Five purification process routes, precise purification solutions, protect the structure integrity , and ensure immunogenicity.

Pivotal Phase III clinical trials demonstrated that in healthy individuals aged ≥2 years, the seroconversion rates for all 23 serotypes were non-inferior to the comparator vaccine, with superiority shown for multiple serotypes, indicating favorable immunogenicity.¹ For detailed data, refer to the [Clinical Trials] section of the prescribing information.

(For reference by medical and pharmaceutical professionals only) 

[Generic Name] 23-valent Pneumococcal Polysaccharide Vaccine

[COMPOSITION]

This product is a polysaccharide vaccine prepared through culture and purification of the widely prevalent and invasive serotypes of pneumococcus, comprising 23 serotypes in total, including 1, 2, 3,4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F,18C, 19A, 19F, 20, 22F, 23F and 33F.

Active ingredients: 23 pneumococcal polysaccharide serotypes Excipients: Sodium chloride, disodium hydrogen

phosphate, sodium dihydrogen phosphate and water for injection.

The product is free of preservatives.

[TARGET POPULATION]

The product is indicated for active immunization of individuals aged over 2 years who are under the increased risk of pneumococcal infection. For detailed information, please refer to the product insert.

[THERAPEUTIC INDICATION]

The vaccine is indicated for active immunization against and prevention of infection disease caused by 23 pneumococcal serotypes contained in the product.

[PRESENTATION]

Vial: 0.5 mL/vial; Pre-filled syringe: 0.5 mL/syringe. Each 0.5 mL dose contains 25 μg of each of the 23 pneumococcal capsular polysaccharides.

[POSOLOGY AND METHOD OF ADMINISTRATION]

Administration site and route: Intramuscular injection into the deltoid muscle of the lateral upper arm.

(1) Administration dosage and regimen: 0.5 mL per dose

(2) Revaccination: 0.5 mL per dose The Advisory Committee on Immunization Practices (ACIP) has recommendations for revaccination against pneumococcal disease for persons at high risk who were previously vaccinated with this product.

[ADVERSE REACTION]

Very common: Injection site pain, fever. Common: Injection site swelling, redness; asthenia/fatigue, headache, cough, diarrhea, nausea/vomiting. Uncommon: Injection site pruritus, induration, rash; myalgia. For details, please refer to the full prescribing information.

[CONTRAINDICATION]

(1) Hypersensitivity to the active substances or any of the excipients.

(2) Fever, acute infection, acute exacerbation of chronic diseases.

[SHELF LIFE]

24 months from the date of final bulk formulation

[APPROVAL NUMBER] National Medical Products Administration (NMPA) Approval No. S20200027

[REGISTRATION CERTIFICATE HOLDER] SINOVAC BIOTECH LTD.

For detailed information regarding [DRUG INTERACTIONS], [USE IN PREGNANCY AND LACTATION], [USE IN CHILDREN], [PRECAUTIONS], [CLINICAL TRIALS], [STORAGE], [PACKAGING], etc., please refer to the Product Insert.

References

[1]Huang L, et al. Hum Vaccin Immunother. 2019;15(1):249-255.

(For reference by medical and pharmaceutical professionals only)