Indications and Usage
- Pneumo 23 is indicated for high risk subjects >2 years of age to prevent pneumococcal pneumonia and systemic pneumococcal infections caused by the serotypes included in the vaccine.
- Elderly people from 65 years of age
- Immunocompetent patients with chronic illness (eg. cardiovascular disease, pulmonary disease, diabetes mellitus, alcoholism, cirrhosis, cerebrospinal fluid leaks).
- Immunocompromised patients: anatomic or functional asplenia (including patients to be splenectomized), sickle cell disease, Hodgkins disease, lymphoma, multiple myeloma, chronic renal failure, nephrotic syndrome and organ transplantation.
- Asymptomatic or symptomatic HIV infected patients.
- Special groups: persons living in a social or working environment with an identified increased risk of pneumococcal infection or its complications (eg. hospitalized elderly people or those in institutional care).
Dosage and Administration
Primary immunisation consists of a single 0.5mL dose. Intramuscular administration (i.m.) is preferred, although subcutaneous injection (s.c.) can be used.
Reimmunisation consists of a single 0.5 mL dose, administered by intramuscular or subcutaneous injection. Given the current state of knowledge, systemic reimmunisation of all subjects previously given pneumococcal vaccine is not necessary. It is however recommended for subjects at high risk of pneumococcal infection (eg. people with asplenia), who were given pneumococcal vaccine more than 5 years ago, or whose antibody titre has been declining sharply (eg. nephrotic syndrome, renal failure or people with organ transplant). A reimmunisation every 3 or 5 years is also recommended for children under 10 years of age with nephrotic syndrome, asplenia or sickle cell disease.
Dosage Forms and Strengths
1 single dose prefilled syringe (0.5 mL)
- Hypersensitivity to any component of the vaccine.
- Usual contraindications to any immunisation: immunisation should be delayed in case of significant febrile illness, acute disease, relapse of chronic disease, unless a lethal risk exists (see Indications).
- Immunization is not recommended in subjects who were given a pneumococcal vaccine within the previous three years, except in specific indications (see Dosage and Administration).
- A confirmed or suspected episode of pneumococcal infection is not a contraindication and should be considered according to underlying risk status (see Adverse Effects).
Warnings and Precaution
- Do not inject vaccine intradermally.
- PNEUMO 23 should never be injected intravascularly and precautions should be taken to make sure the needle does not enter a blood vessel.
- It is recommended that pneumococcal vaccine be given at least two weeks before a splenectomy, the initiation of chemotherapy or of an immunosuppressive treatment. Required prophylactic antibiotic therapy against pneumococcal infection should not be stopped after immunization with the vaccine.
- Local reactions at the injection site: pain, erythema, induration and oedema are the more commonly reported reactions. These reactions are generally mild and transient.
- Very rare Arthus-like reactions have been reported. They are reversible without after-effects and mainly occur in persons with high initial pneumococcal antibody levels.
- Systemic reactions: a moderate and transient fever (>38 C) is observed in about 2% of patients. Fever (> 39 C) may rarely be observed. Febrile episodes mostly occur very early after vaccination. They are self-resolving within 24 hours.
- Other general reactions such as lymphadenopathy, rash, urticaria, arthralgia, anaphylactoid reactions, headache, myalgia, malaise, asthenia and fatigue have been exceptionally reported.
Use in Specific Populations
- The vaccine is not recommended during the first trimester of pregnancy. A clinical trial was performed with PNEUMO 23 in pregnant women during the third trimester. No significant adverse events were recorded.
- Breast feeding is not a contra-indication to pneumococcal vaccination. PNEUMO 23 may be given to lactating women.