Pneumococcal Polysaccharide Vaccine (23-Valent)
Medically reviewed on Nov 15, 2018
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- 23-Valent Pneumococcal Polysaccharide Vaccine
- Pneumococcal Polysaccharide Vaccine (Polyvalent)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Pneumovax 23: 25 mcg each of 23 capsular polysaccharide isolates/0.5 mL (0.5 mL, 2.5 mL) [contains phenol]
Brand Names: U.S.
- Pneumovax 23
- Vaccine, Inactivated (Bacterial)
Pneumococcal polysaccharide polyvalent is an inactive bacterial vaccine that induces active immunization to the serotypes contained in the vaccine. Although there are more than 90 known pneumococcal capsular types, pneumococcal disease is mainly caused by only a few serotypes of pneumococci. Pneumococcal vaccine polyvalent contains capsular polysaccharides of 23 pneumococcal types of Streptococcus pneumoniae that represent at least 85% to 90% of pneumococcal disease isolates in the US. The 23 capsular pneumococcal vaccine contains purified capsular polysaccharides of pneumococcal types 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F.
Efficacy: In adults, PPSV23 demonstrated 50% to 80% efficacy in preventing invasive pneumococcal disease due to relevant serotypes of S. pneumoniae (CDC/ACIP 59 2010).
Onset of Action
Immunity develops within approximately 2 to 3 weeks after vaccination (Pink Book [Atkinson 2012])
Duration of Action
Protective antibody levels persist for at least 5 years. A more rapid decline may occur in some groups (eg, children, elderly) (Pink Book [Atkinson 2012])
Use: Labeled Indications
Pneumococcal disease prevention: Active immunization of children ≥2 years and persons ≥50 years who are at increased risk for pneumococcal disease caused by the 23 serotypes included in the vaccine.
The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for patients with the following underlying medical conditions (ACIP [Kobayashi 2015]; CDC/ACIP 59 2010; CDC/ACIP 61 2012]; CDC/ACIP [Nuorti 2010]; CDC/ACIP [Tomczyk 2014]):
Children ≥2 years of age, adolescents, and adults 19 to 64 years with functional or anatomic asplenia, including sickle cell disease or other hemoglobinopathies, congenital or acquired asplenia, splenic dysfunction, or splenectomy
Immunocompetent children ≥2 years of age and adolescents with chronic heart disease (particularly cyanotic congenital heart disease and heart failure), chronic lung disease (including asthma if treated with high dose corticosteroids), diabetes, cerebrospinal fluid leaks, or cochlear implants
Immunocompetent adults 19 to 64 years with chronic heart disease (including heart failure and cardiomyopathies; excluding hypertension), chronic lung disease (including COPD, emphysema, and asthma), diabetes, cerebrospinal fluid leaks, cochlear implants, alcoholism, chronic liver disease, cirrhosis, and cigarette smokers
Immunocompromised children ≥2 years of age, adolescents, and adults 19 to 64 years with congenital or acquired immunodeficiency (includes B or T cell deficiency, compliment deficiencies and phagocytic disorders; excludes chronic granulomatous disease), HIV infection, chronic renal failure, nephrotic syndrome, leukemia, lymphoma, Hodgkin disease, generalized malignancies, solid organ transplant, multiple myeloma, or other diseases requiring immunosuppressive drugs (including long-term systemic corticosteroids and radiation therapy)
All adults ≥65 years of age
Severe allergic reaction (eg, anaphylactic/anaphylactoid reaction) to pneumococcal vaccine or any component of the formulation
Immunization: Adults 19 to <65 years with specified underlying medical conditions: IM, SubQ: 0.5 mL as a single dose. Note: Some medical conditions do not require pneumococcal conjugate vaccine (PCV13) [see guidelines for details] (ACIP [Kobayashi 2015]):
Pneumococcal vaccine-naive or vaccination status unknown: Administer PCV13 followed by pneumococcal polysaccharide vaccine (PPSV23) at least 8 weeks later
Previously received PPSV23 but not PCV13: No additional PPSV23 doses needed for primary vaccination; administer PCV13 ≥1 year after the last PPSV23 dose was received
Previously received PCV13 but not PPSV23: Administer PPSV23 at least 8 weeks after PCV13
Revaccination: Adults 19 to 64 years with functional or anatomic asplenia, chronic renal failure or nephrotic syndrome, HIV, or who are immunocompromised: One PPSV23 revaccination dose ≥5 years after first dose of PPSV23 and ≥8 weeks after PCV13. Note: If PPSV23 is given before PCV13, the minimum interval is 1 year (ACIP [Kroger 2017]).
Immunization: Adults ≥65 years: IM, SubQ: 0.5 mL as a single dose. Note: All patients should receive both pneumococcal conjugate vaccine (PCV 13) and pneumococcal polysaccharide vaccine (PPSV23) (see below) (ACIP [Kobayashi 2015]; CDC/ACIP [Tomczyk 2014]):
Pneumococcal vaccine-naive or vaccination status unknown: Administer PCV13 followed by PPSV23 ≥1 year later (minimum interval of 8 weeks for certain high-risk groups)
Previously received PPSV23 (at age <65 years) but not PCV13: Administer PCV13 ≥1 year after the last dose of PPSV23; administer PPSV23 ≥1 year later (minimum interval of 8 weeks for certain high-risk groups) and at least 5 years after the last PPSV23 dose
Previously received PPSV23 (at age ≥65 years) but not PCV13: No additional PPSV23 doses are needed; administer PCV13 ≥1 year after the last dose of PPSV23
Previously received PCV13 but not PPSV23: Administer PPSV23 ≥1 year after the PCV13 dose (minimum interval of 8 weeks for certain high-risk groups) or as soon as possible if this time window has passed
Primary vaccination: Children ≥2 years and Adolescents with specified underlying medical conditions: IM, SubQ: 0.5 mL as a single dose. Immunization with pneumococcal conjugate vaccine (PCV13) should be completed prior to PPSV23 as recommended. The minimum interval between PCV13 and PPSV23 is 8 weeks (CDC/ACIP [Nuorti 2010]).
Revaccination: Children ≥2 years and Adolescents with functional or anatomic asplenia, those who are immunocompromised, and others with high-risk medical conditions [see guidelines for details]: One revaccination dose ≥5 years after the first dose of PPSV23.
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer’s labeling.
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer’s labeling.
IM, SubQ: Administer SubQ or IM (deltoid muscle or lateral midthigh). Do not inject IV; avoid intradermal administration (may cause severe local reactions). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (ACIP [Kroger 2017]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.
For patients at risk of hemorrhage following intramuscular injection, the vaccine should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (ACIP [Kroger 2017]).
Store at 2°C to 8°C (36°F to 46°F).
Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification
Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification
Pneumococcal Conjugate Vaccine (13-Valent): Pneumococcal Polysaccharide Vaccine (23-Valent) may diminish the therapeutic effect of Pneumococcal Conjugate Vaccine (13-Valent). Management: It is recommended to administer PCV13 prior to administration of PPSV23. The recommended interval between vaccine administrations differs by patient age and comorbidities. See full monograph for details. Consider therapy modification
Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy
Zoster Vaccine (Live/Attenuated): Pneumococcal Polysaccharide Vaccine (23-Valent) may diminish the therapeutic effect of Zoster Vaccine (Live/Attenuated). Monitor therapy
Frequency not defined.
Cardiovascular: Peripheral edema (in injected extremity)
Central nervous system: Chills, Guillain-Barré syndrome, febrile seizures, headache, malaise, pain, paresthesia, radiculopathy
Dermatologic: Cellulitis, skin rash, urticaria
Gastrointestinal: Nausea, vomiting
Hematologic & oncologic: C-reactive protein increased, hemolytic anemia (in patients with other hematologic disorders), leukocytosis, lymphadenitis, lymphadenopathy, thrombocytopenia (in patients with stabilized immune thrombocytopenia [formerly known as idiopathic thrombocytopenic purpura])
Hypersensitivity: Anaphylactoid reaction, angioedema, serum sickness
Local: Injection site reaction (most common in clinical trials; includes erythema at injection site, induration at injection site, local soreness/soreness at injection site, swelling at injection site, warm sensation at injection site)
Neuromuscular & skeletal: Arthralgia, arthritis, decreased range of motion (limb), myalgia, weakness
Miscellaneous: Fever (most common in clinical trials: ≤102°F; fever >102°F)
Concerns related to adverse effects:
• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2017]).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2017]).
• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2017]).
• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2017]).
• Cardiovascular disease: Use with caution in patients with severely compromised cardiovascular function where a systemic reaction may pose a significant risk.
• HIV: Patients with HIV should be vaccinated as soon as possible following confirmation of the diagnosis (CDC/ACIP, 61 2012).
• Cerebrospinal fluid (CSF) leaks: Vaccination may not be as effective in patients with chronic CSF leaks due to congenital lesions, skull fractures, or neurosurgical procedures.
• Pneumococcal meningitis: Pneumococcal vaccine may not be effective in preventing pneumococcal meningitis in persons who have chronic cerebrospinal fluid leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.
• Respiratory disease: Use with caution in patients with severe pulmonary disease where a systemic reaction may pose a significant risk.
• Splenectomy: Patients who will undergo splenectomy should also be vaccinated at least 2 weeks prior to surgery, if possible (IDSA [Rubin 2014]).
• Thrombocytopenia purpura: May cause relapse in patients with stable idiopathic thrombocytopenia purpura.
Concurrent drug therapy issues:
• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2017]).
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist (ACIP [Kroger 2017]). If a person has not received any pneumococcal vaccine or if pneumococcal vaccination status is unknown, PPSV23 should be administered as indicated.
• Antibiotic prophylaxis: This vaccine does not replace the need for penicillin (or other antibiotic) prophylaxis against pneumococcal infection. In persons who require penicillin (or other antibiotic) prophylaxis against pneumococcal infection, such prophylaxis should not be discontinued after vaccination with pneumococcal vaccine.
• Altered immunocompetence: Consider deferring immunization during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]); may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2017]; (IDSA [Rubin 2014]).
• Children: Pneumococcal vaccine is not approved for use in children <2 years. Children in this age group do not develop an effective immune response to the capsular types contained in this polysaccharide vaccine.
• Cochlear implants: Patients who will undergo cochlear implant placement should be vaccinated at least 2 weeks prior to surgery, if possible (IDSA [Rubin 2014]).
• Elderly: Postmarketing reports of adverse effects in elderly patients, especially those with comorbidities, have been significant enough to require hospitalization.
• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the annual ACIP Recommended Immunization Schedules (refer to CDC schedule for detailed information). Specific recommendations for use of this vaccine in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions are available from the IDSA (Rubin 2014). Vaccination does not replace the need for antibiotic prophylaxis against pneumococcal infection when otherwise required.
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2017]). One study reported that routine prophylactic administration of acetaminophen prior to vaccination to prevent fever decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2017]).
Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2017]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
Pregnancy Risk Factor
Animal reproduction studies have not been conducted. Vaccination should be considered in pregnant women at high risk for infection. Inactivated vaccines have not been shown to cause increased risks to the fetus (ACIP [Kroger 2017]).
• Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience injection site pain or irritation, headache, loss of strength and energy, or muscle pain (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
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