Poliomyelitis Vaccine (Vero Cell), Inactivated, Sabin Strains
A WHO-Prequalified Inactivated Poliomyelitis Vaccine
This vaccine is developed and produced leveraging advanced international technology cooperation. It utilizes bioreactor and microcarrier culture systems, offering advantages over traditional processes such as larger production scale, more precise process control, and lower aseptic control risks.
The single-dose presentation contains no preservatives or antibiotics.
It has received prequalification from the World Health Organization (WHO).
Key Features
Favorable Safety Profile
Phase I-III clinical trials demonstrated good overall tolerability. Adverse reactions were predominantly mild to moderate in severity.1-3
High Immunogenicity
Following the primary series, seroconversion rates for type I, II, and III poliovirus antibodies were 98.0%, 94.8%, and 98.9%, respectively.3
Advanced Manufacturing Process
The modern production process ensures consistent product quality and scalable supply.
Highlights of Prescribing Informatio
Product Name
Generic Name: Polio Vaccine (Vero Cell), Inactivated, Sabin Strains
Composition
Each 0.5ml dose contains:
Active substances:
Poliovirus type I (inactivated) 15 DU (D-antigen unit)
Poliovirus type II (inactivated) 45 DU
Poliovirus type III (inactivated) 45 DU
Excipients: Medium 199, Glycine, Sodium chloride, Potassium chloride, Calcium chloride, Magnesium sulfate, Disodium hydrogen phosphate, Sodium dihydrogen phosphate.
This product contains no preservatives or antibiotics.
Description
Target Population
Infants and children, primarily for infants aged 2 months and above.
Therapeutic Indication
For active immunization to prevent poliomyelitis caused by poliovirus types I, II, and III.
Dosage and Administration
This vaccine must be used under the guidance of national immunization programs and relevant policies, as directed by national health administrative departments and disease control agencies.
Administration: Intramuscular injection. The preferred site for infants is the mid-anterolateral thigh; for children, the deltoid muscle of the upper arm.
Schedule: Primary immunization consists of 3 doses. The first dose is given at 2 months of age, followed by 2 subsequent doses, each administered at least 1 month apart. A booster dose is recommended at 18 months of age. Each dose is 0.5ml.
Common adverse reactions include fever (≥37.1°C), diarrhea, nausea, vomiting, decreased appetite, and injection site reactions (e.g., pain, redness, swelling). For a complete list of adverse reactions, please refer to the full product prescribing information.
Contraindications
(1) Hypersensitivity to the active substances, any excipient, or substances used in the manufacturing process (e.g., kanamycin), or a history of allergic reaction to this vaccine or similar vaccines. (2) Severe chronic disease or allergic constitution. (3) Administration should be postponed in patients with fever or acute illness.
Important Safety Note
This vaccine must be used under the guidance of a healthcare professional. Recipients should be observed for at least 30 minutes after vaccination.
Shelf Life
36 months.
Approval Number
National Medical Products Administration (NMPA) Approval No. S20210023
National Medical Products Administration (NMPA) Approval No. S20210024
Manufacturer
Sinovac Biotech (Beijing) Co., Ltd.
For detailed information on [Precautions], [Storage], and [Packaging], please refer to the full product prescribing information.
References: [1] Chu K, et al. Vaccine. 2018;36(45):6782-6789. [2] Hu YM, et al. J Infect Dis. 2019;220(10):1551-1557. [3] Hu YM, et al. Open Forum Infect Dis. 2019;6(10):ofz380.
Disclaimer: This overview is for informational purposes only and is intended for healthcare professionals. It does not replace the official product prescribing information or professional medical advice. Please always refer to the latest approved full prescribing information for complete guidance on the use of this product.
EN
