Pneumo 230.5 ml

Pneumo 23 is indicated for active immunization for the prevention of invasive pneumococcal disease (e.g., bacteremia, meningitis) and pneumonia caused by the 23 Streptococcus pneumoniae serotypes contained in the vaccine.

Established/Guideline-Supported Uses

• Adults aged 65 years and older (routine immunization).
• Adults 19-64 years with chronic conditions (e.g., chronic heart, lung, or liver disease; diabetes mellitus; alcoholism; cigarette smoking).
• Persons aged 2 years and older with functional or anatomic asplenia (including sickle cell disease), cerebrospinal fluid leak, or cochlear implants.
• Immunocompromised persons aged 2 years and older (e.g., HIV infection, chronic renal failure, nephrotic syndrome, leukemia, lymphoma, generalized malignancy, organ or bone marrow transplantation, or those on immunosuppressive chemotherapy including long-term systemic corticosteroids).
• Residents of nursing homes or long-term care facilities.

Use in Combination with Other Vaccines

In certain adults and high-risk children, national immunization schedules recommend sequential use of a pneumococcal conjugate vaccine followed by Pneumo 23 to broaden serotype coverage; the two vaccine types are not interchangeable and Pneumo 23 does not replace conjugate vaccination where that is indicated.

Not indicated for children under 2 years of age, as this age group does not reliably develop a protective antibody response to the polysaccharide antigens in Pneumo 23.

Each 0.5 mL dose of Polysaccharide Pneumococcal Vaccine contains 25 micrograms each of purified capsular polysaccharide antigen from 23 serotypes of Streptococcus pneumoniae, dissolved in isotonic saline solution containing phenol or a similar preservative as an inactive ingredient.

Pneumo 23 is a sterile, liquid vaccine composed of a mixture of purified capsular polysaccharides from 23 of the most common disease-causing serotypes of Streptococcus pneumoniae, which together account for a large majority of invasive pneumococcal disease worldwide. Pneumo 23 works by stimulating the body's immune system to produce protective antibodies against these specific bacterial capsular types.

Pneumo 23 is administered as a single intramuscular or subcutaneous injection and is distinct from pneumococcal conjugate vaccines, which use a different technology (polysaccharide antigens conjugated to a carrier protein) to also generate a T-cell-dependent immune response effective in infants.

Pneumo 23 belongs to the therapeutic class of bacterial vaccines, specifically the pneumococcal polysaccharide vaccines used for active immunoprophylaxis against Streptococcus pneumoniae infection.

Polysaccharide Pneumococcal Vaccine contains purified capsular polysaccharide antigens that, upon injection, stimulate a T-cell-independent B-lymphocyte immune response, leading to production of type-specific opsonizing and protective antibodies against the corresponding Streptococcus pneumoniae serotypes.

Protective antibody levels are generally reached within 2-3 weeks after administration of Polysaccharide Pneumococcal Vaccine in immunocompetent individuals. Because the immune response elicited by Polysaccharide Pneumococcal Vaccine is T-cell-independent, it does not generate strong immunologic memory (booster/anamnestic response) and antibody titers decline over time, particularly in older adults and immunocompromised individuals, which is why revaccination is considered in specific high-risk groups.

• Pneumo 23 is given as a single 0.5 mL intramuscular (preferred, e.g., deltoid muscle) or subcutaneous injection.
• Do not administer intravenously or intradermally.
• Inspect the vial/syringe visually for particulate matter or discoloration before use; discard if present.
• Shake well before withdrawing/administering the dose to ensure a uniform suspension.
• Use a separate syringe and injection site if Pneumo 23 is given at the same visit as another injectable vaccine.

Pneumo 23 may be administered concomitantly with other vaccines (e.g., influenza vaccine) using separate syringes and separate injection sites; however, when co-administration is undesirable or a conjugate pneumococcal vaccine is also being given, appropriate spacing per national immunization guidance should be followed.

Immunosuppressive therapy (e.g., chemotherapy, radiation therapy, high-dose systemic corticosteroids): concurrent immunosuppressive treatment can blunt the antibody response to Pneumo 23; where possible, vaccination should be scheduled at least 2 weeks before starting, or deferred until after completing, such therapy.

Immune globulin or other antibody-containing blood products administered close in time to Pneumo 23 are not known to significantly impair the response to this polysaccharide vaccine (unlike live vaccines), but clinical judgment on timing should still apply.

Common (may affect more than 1 in 10 people)

• Injection-site pain, soreness, or tenderness
• Injection-site swelling, induration, or redness (erythema)
• Low-grade fever
• Headache
• Fatigue and myalgia (muscle aches)

Uncommon/Rare

• High fever
• Lymphadenopathy near the injection site
• Localized limb swelling

Rare but Serious

• Severe allergic reaction/anaphylaxis (see Contraindications)
• Guillain-Barré syndrome
• Serum sickness-like reaction
• Thrombocytopenia (in individuals with pre-existing platelet disorders)

Most reactions to Pneumo 23 are mild and self-limited, resolving within a few days. Revaccination may be associated with more pronounced local reactions than the initial dose, particularly in older adults.

Pregnancy: Adequate and well-controlled studies of Pneumo 23 in pregnant women are limited. Pneumo 23 should be used during pregnancy only if clearly needed, and only if the potential benefit justifies the potential risk to the fetus; consult a physician before use in pregnancy.

Lactation: It is not known whether components of Pneumo 23 are excreted in human breast milk. Caution is advised, and a physician should be consulted before using Pneumo 23 while breastfeeding, weighing the benefit of maternal/infant protection against any theoretical risk.

Pneumo 23 should not be relied upon to protect against pneumococcal disease caused by serotypes not contained in the vaccine, nor against other causes of pneumonia, bronchitis, or upper respiratory infection.

• Acute illness: Defer administration of Pneumo 23 in persons with moderate-to-severe acute febrile illness until they have recovered; minor illnesses (e.g., mild upper respiratory infection) are not a reason to delay.
• Immunocompromised individuals: Persons with impaired immune responsiveness (e.g., due to HIV infection, malignancy, chemotherapy, high-dose corticosteroids, or organ/bone marrow transplantation) may have a reduced antibody response to Pneumo 23; vaccination is nonetheless generally recommended in these groups given their higher risk of invasive pneumococcal disease.
• Bleeding disorders/thrombocytopenia: Administer Pneumo 23 with caution and appropriate technique (e.g., a fine needle with firm pressure applied, no rubbing) in individuals with thrombocytopenia or a bleeding disorder, or those on anticoagulant therapy, due to the risk of bleeding/hematoma at the injection site.
• Not a substitute: Pneumo 23 does not replace routine antibiotic prophylaxis for prevention of pneumococcal infection in high-risk individuals (e.g., asplenia) where that is separately indicated.
• Cardiopulmonary disease: Use caution in persons with severely compromised cardiac or pulmonary function, in whom a systemic reaction could pose an acute risk.
• As with any vaccine, appropriate medical treatment for managing possible anaphylactic reactions must be immediately available after administration of Pneumo 23.

There is no clinical experience with overdosage of Pneumo 23, as it is administered as a single measured dose by a healthcare professional. Should an excessive dose or vaccination error occur, or if severe symptoms (e.g., difficulty breathing, swelling of the face/throat, severe dizziness, widespread rash) develop after administration of Pneumo 23, seek immediate medical attention or contact emergency services. Do not attempt to manage a suspected overdose or severe reaction at home.

Store in a refrigerator at 2-8°C (36-46°F). Do not freeze; discard if the vaccine has been frozen. Protect from light. Keep out of reach of children. Discard any unused portion after the expiration date.

Elderly

Pneumo 23 is routinely recommended for adults 65 years of age and older, in whom the risk of invasive pneumococcal disease is elevated; antibody response may be somewhat lower than in younger adults but vaccination is still beneficial.

Renal Impairment

Patients with chronic renal failure or nephrotic syndrome are at increased risk of pneumococcal infection and are a specific target group for Pneumo 23; no dose adjustment is required, though antibody response may be diminished.

Hepatic Impairment

Patients with chronic liver disease (including cirrhosis) are a specific target group for Pneumo 23 due to increased infection risk; no dose adjustment is required.

Immunocompromised Patients

See Precautions and Warnings — vaccination with Pneumo 23 is generally recommended despite a potentially blunted antibody response.

Pneumo 23 is not a treatment course but a preventive immunization given as a single dose. Protective effect is expected to begin within 2-3 weeks of vaccination. Revaccination with a single additional dose of Pneumo 23 may be considered in specific high-risk individuals after an interval of at least 5 years, per national immunization guidance (see Dosage and Administration).

Polysaccharide Pneumococcal Vaccine is classified as a polysaccharide bacterial vaccine within the broader category of vaccines/immunizing biological agents.

Polysaccharide Pneumococcal Vaccine works by exposing the immune system to purified, non-infectious capsular polysaccharide antigens from 23 serotypes of Streptococcus pneumoniae. B lymphocytes recognize these polysaccharide antigens directly (a T-cell-independent mechanism) and differentiate into plasma cells that secrete type-specific antibodies. These antibodies opsonize the corresponding pneumococcal bacteria, facilitating their recognition and destruction by phagocytic cells, thereby providing protection against invasive disease caused by the serotypes covered by Polysaccharide Pneumococcal Vaccine.

Pneumo 23 is not recommended for children younger than 2 years of age, because this age group does not reliably mount an adequate protective antibody response to polysaccharide antigens.

In children 2 years of age and older with qualifying high-risk conditions (e.g., functional/anatomic asplenia including sickle cell disease, immunocompromise, chronic cardiac/pulmonary/renal/liver disease, cochlear implant, or cerebrospinal fluid leak), Pneumo 23 is given as a single 0.5 mL dose, typically following completion of the age-appropriate pneumococcal conjugate vaccine series, per national immunization schedule guidance. Safety and efficacy of Pneumo 23 in children under 2 years have not been established.