Pneumococcal Polysaccharide Vaccine (23-Valent)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, solution:

Pneumovax 23: 25 mcg each of 23 capsular polysaccharide isolates/0.5 mL (0.5 mL, 2.5 mL) [contains phenol]

Pharmacology

Mechanism of Action

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[34] 2010).

Pharmacokinetics/Pharmacodynamics

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[34] 2010; CDC/ACIP 61[40] 2012]; CDC/ACIP [Matanock 2019]); CDC/ACIP [Nuorti 2010]:

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 chronic obstructive pulmonary disease, 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, complement 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

Contraindications

Severe allergic reaction (eg, anaphylactic/anaphylactoid reaction) to pneumococcal vaccine or any component of the formulation

Dosage and Administration

Dosing: Adult

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]):

Primary vaccination:

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]).

Dosing: Geriatric

Immunization: Adults ≥65 years: IM, SubQ: 0.5 mL as a single dose. Note: All patients should receive routine pneumococcal polysaccharide vaccine (PPSV23) (see below) (ACIP [Kobayashi 2015]; CDC/ACIP [Matanock 2019]):

Pneumococcal vaccine-naive or vaccination status unknown: Administer a single dose of PPSV23 ≥1 year after the PCV13 dose (minimum interval of 8 weeks for certain high-risk groups).

Previously received PPSV23 (at age <65 years) but not PCV13: Administer PPSV23 ≥1 year after the PCV13 dose (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.

Dosing: Pediatric

Note: Consult CDC/ACIP annual immunization schedules for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (ACIP [Kroger 2017]).

Primary immunization: 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 pneumococcal polysaccharide vaccine (PPSV23) as recommended. The minimum interval between PCV13 and PPSV23 is 8 weeks (AAP 2010; ACIP [Kobayashi 2015]; CDC/ACIP [Nuorti 2010]).

Revaccination: Children ≥2 and Adolescents with functional or anatomic asplenia, those who are immunocompromised, and others with high-risk medical conditions [see guidelines for specific details]: One revaccination dose ≥5 years after the first dose of PPSV23.

Storage

Store at 2°C to 8°C (36°F to 46°F).

Drug Interactions

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

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. 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

Adverse Reactions

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)

Warnings/Precautions

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]).

Disease-related concerns:

• 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[40] 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.

Special populations:

• 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.

Other warnings/precautions:

• 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]).

Monitoring Parameters

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

Pregnancy Considerations

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]).

Patient Education

What is this drug used for?

• It is used to prevent pneumococcal disease.

Frequently reported side effects of this drug

• Injection site pain, redness, or swelling
• Headache
• Loss of strength and energy
• Muscle pain
• Signs of a significant reaction like 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. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.