Pneumops 23

The Pneumococcal Polysaccharide Vaccine, 23-Valent (PPSV23) is a sterile liquid vaccine consisting of a mixture of purified capsular polysaccharides from Streptococcus pneumoniae serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F. No preservatives are added. This vaccine is supplied as a single-dose, pre-filled syringe. This vaccine is presented as a clear and colorless solution.
Active substances: Capsular polysaccharides of Streptococcus pneumoniae serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F.
Excipients/Inactive Ingredients: Sodium dihydrogen phosphate monohydrate 30 μg, disodium hydrogen phosphate dodecahydrate 35.5 μg, sodium chloride 4.25 mg, and water for injection up to 0.5 mL per dose.
The vaccine is supplied in a single-dose, prefilled syringe with 0.5 mL solution for intramuscular or subcutaneous injection. Each one dose (0.5 mL) of PPSV23 contains: See Table 1.

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Pharmacology: Pharmacodynamic/Pharmacokinetics: Not applicable.
Clinical Trials: The safety and immunogenicity of this vaccine were evaluated in a phase III, randomized, double-blind and non-inferiority study designed with a positive control of imported similar vaccine. The blood samples were collected pre-immunization as well as on Day 30 and 35 post-immunization, respectively. The ELISA assay was used to detect the pneumococcal antibody concentrations of 23 serotypes. The percentages of subjects with 2-fold increase in the antibody concentrations of each serotype were compared to those obtained pre-immunization for both the PPSV23 group and the PNEUMOVAX 23 group. The overall percentage of subjects with 2-fold increase in the antibody concentrations of all 23 serotypes and the geometric mean antibody concentrations (GMCs) were also determined.
A total of 1660 subjects were enrolled in the phase III study, among which 1619 cases (97.53%) completed all study procedures, and 41 cases (2.47%) dropped out, resulting in 1619 cases (97.53%) included in the Full Analysis Set (FAS), and 1606 cases (96.75%) in the Per-Protocol Set (PPS). All subjects were involved in the safety analysis. FAS was determined as the primary analysis set, and the results obtained from FAS were basically consistent with those from PPS (Table 2 and Table 3). (See Tables 2 and 3.)

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Click on icon to see table/diagram/image

The vaccine is indicated for using in individuals aged ≥2 years who are at increased risk of pneumococcal disease.
The vaccine elicits immune response in recipients following immunization and is indicated for the prevention of pneumococcal diseases caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F). The vaccine will not prevent diseases caused by capsular types of Streptococcus pneumoniae other than those contained in the vaccine.

Injection Site and Route of Administration: This product is for intramuscular or subcutaneous injection (intramuscularly recommended) and the preferred administration site is the deltoid muscle of the lateral upper arm or lateral mid-thigh. Intravascular and intradermal injection is prohibited.
Dosage: Single dose (0.5 mL).
Revaccination: Persons at high risk (splenectomy) who were previously vaccinated over 5 years or with significant decreasing antibody titers (e.g., nephrotic syndrome, renal failure and organ transplantation) are recommended to revaccinate against pneumococcal diseases.
Children under 10 years old with nephrotic syndrome, splenectomy or sickle cell diseases are recommended to revaccinate 3-5 years later after the initial vaccination.
The immune persistence of this product has so far not demonstrated by any clinical study. The recommendations for revaccination previously mentioned are compiled based on the recommendations for subsequent doses of PPSV23 prescribed in the Prevention of Pneumococcal Diseases-Recommendations by the Advisory Committee on Immunization Practices (CDC, United States, 1997).

Overdose with PPSV23 is unlikely due to its presentation as a single-dose pre-filled syringe. No overdose data are currently available for the product in recipients.

This vaccine should not be administered to: Individuals with allergic reactions to any component of the vaccine.
Individuals with encephalopathy, uncontrolled epilepsy, or other progressive diseases of the nervous system.
Individuals with fever, acute infection, or chronic diseases at the acute stage.
Only if clearly needed, otherwise revaccination within 3 years is not recommended.

Do not administer intracutaneously or intravenously, and ensure the syringe needle is not puncturing blood vessels during inoculation.
The vaccine shall be administered with caution to nursing women or individuals with family or individual history of convulsion, history of epilepsy and allergic diathesis.
Check if the package, container, label, appearance and expiration date of the vaccine follow corresponding requirements before administration. Do not use the vaccine in case that any crack is observed in the container, loosened stopper, detached label, particulate matter or discoloring inside the container, etc. Do not use the vaccine after the expiration date.
Use immediately after unsealing. A single human dose shall be used up each time according to prescribed information.
Appropriate monitoring, medical care and rescue measures should be readily available in case of rare hypersensitivity reactions during vaccination. The recipient shall be observed for at least 30 minutes on site following injection.
If allergic reactions occur after vaccination, please visit the vaccination site or hospital in time.
Do not freeze. Discard if the vaccine has been frozen.
Use in Children: Do not administer the vaccine to children below 2 years of age.

Pregnancy: Administering this vaccine in pregnant women is not recommended. Administration of the vaccine in this population is determined by doctors based on the risk faced with the potential recipients.
Lactation: Administration of the vaccine in nursing mothers should be determined by doctors with caution.

Clinical Trial Experience with PPSV23: Two clinical trials (phase I and III) of PPSV23 were conducted in China, including 60 and 1660 subjects, respectively. Among all subjects (N=1720), subjects included in phase I clinical trial (N=60) and subjects in the PPSV23 group of phase III clinical trial (N=830) were administered with one dose of PPSV23. All subjects were observed for 30 minutes after immunization at the investigation site, and the investigator actively collected the systemic and local reactions through Day 0 to Day 7 after immunization. The adverse events/reactions were reported by the subjects or collected by regular follow-up from Day 8 to Day 30 post immunization.
Summary: The incidence rates of adverse reactions reported in clinical trials, according to the guidance on classifications of adverse events recommended by the Council for International Organizations of Medical Sciences (CIOMS), are classified as: very common (≥10%), common (≥1% to <10%), uncommon (≥0.1% to <1%), rare (≥0.01% to <0.1%), and very rare (<0.01%) as follows: Very common: Local reaction(s): pain.
Common: Local reactions: redness, swelling, itching.
Systemic reactions: fever, fatigue, headache, diarrhea.
Uncommon: Local reaction(s): induration.
Systemic reactions: vomiting, rash, allergy.
Adverse Reactions in Phase III Clinical Trial: Incidence rates and severity of solicited adverse reactions by age groups: The incidence rates and severity of solicited adverse reactions post immunization in phase III clinical trial of PPSV23 in comparison to the comparator vaccine PNEUMOVAX 23 (pneumococcal vaccine polyvalent) manufactured by Merck Sharp & Dohme Ltd., (referred to as PNEUMOVAX 23) are summarized in Table 4 and Table 5. (See Tables 4 and 5.)

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Click on icon to see table/diagram/image

Incidence rate and severity of unsolicited adverse reactions: The overall incidence rate of unsolicited adverse reactions reported by subjects in the PPSV23 group of Phase Ⅲ clinical trial for PPSV23 was 3.98% (33 cases among 830 subjects). The most common unsolicited adverse event was respiratory disease. The incidence of influenza/upper respiratory tract infection in PPSV23 group and PNEUMOVAX 23 group was 2.53% and 2.77%, respectively. No significant difference was observed in the incidence of each unsolicited adverse event between PPSV23 group and PNEUMOVAX 23 group. The documented symptoms include: influenza/upper respiratory tract infection, tonsillitis, pharyngitis, bronchitis, gastrorrhagia, gastroenteritis, vomiting, trauma, myalgia, stomatitis, toothache, systemic pruritus, keratitis, hand-foot-mouth disease, osteoproliferation, thyrophyma, cervical spondylosis, cerebral infarction, dizziness, gynecologic surgery etc.
Post-marketing Experience with PPSV23: The following adverse events have been reported through passive surveillance since the launch of the PPSV23. Considering that these events were reported voluntarily from a population of an uncertain size, the frequency of the events is not always possible to be reliably estimated and the causal relationship between the events and vaccination cannot be established due to the same reason.
The following adverse events were collected based on one or more of the undermentioned elements: frequency of reporting, severity, or strength of evidence for a causal relationship to PPSV23.
General disorders and administration site: fever, injection site swelling, injection site erythema, vaccination site induration.
Skin and subcutaneous tissue disorders: localized erythema, allergic rash, urticaria.
Immune system disorders: allergic reaction.
Infections and infestations: infection upper respiratory.
Nervous system disorders: fever convulsions.
If any adverse reactions not included as previously mentioned occur after administering this vaccine, please contact and report to a physician.

No clinical data of this product co-administered with other vaccines inside or outside China are available. As per the information available for other similar marketed vaccines, PPSV23 may be administered at the same time with influenza vaccine by separate injection in the other arm.
Any medications, being or having recently been administered, including OTCs, should be reported to the physician.

Incompatibilities: This vaccine should not be mixed with other medicinal products considering that no compatibility studies have been conducted.

Transport and store refrigerated at 2°C to 8°C, protect from light.
DO NOT FREEZE. Discard if the vaccine has been frozen.
Shelf Life: The shelf life of the vaccine is 24 months.

Vaccines, Antisera & Immunologicals

J07AL01 - pneumococcus, purified polysaccharides antigen ; Belongs to the class of pneumococcal bacterial vaccines.

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