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Pneumococcal Polysaccharide Vaccine (Polyvalent)

Pronunciation

(noo moe KOK al pol i SAK a ride vak SEEN, TWEN tee three VAY lent)

Index Terms

  • 23-Valent Pneumococcal Polysaccharide Vaccine
  • 23PS
  • Pneumococcal Polysaccharide Vaccine (Polyvalent)
  • PPSV
  • PPSV23
  • PPV23

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)

Brand Names: U.S.

  • Pneumovax 23

Pharmacologic Category

  • Vaccine
  • Vaccine, Inactivated (Bacterial)

Pharmacology

Pneumococcal polysaccharide polyvalent is an inactive bacterial vaccine that induces active immunization to the serotypes contained in the vaccine. Although there are more than 80 known pneumococcal capsular types, pneumococcal disease is mainly caused by only a few types of pneumococci. Pneumococcal vaccine polyvalent contains capsular polysaccharides of 23 pneumococcal types of Streptococcal pneumoniae which represent at least 85% to 90% of pneumococcal disease isolates in the United States. 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).

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 [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

Contraindications

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

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 [Kim 2016]; 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, 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 [Kobayashi 2015]; CDC 61[40] 2012; CDC/ACIP 59[34] 2010).

Dosing: Geriatric

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) (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

Dosing: Pediatric

Immunization: Children ≥2 years and Adolescents: IM, SubQ: 0.5 mL as a single dose

Primary vaccination: Children ≥2 years and Adolescents with specified underlying medical conditions: One dose of pneumococcal polysaccharide vaccine (PPSV23) should be given at ≥2 years of age. 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. Revaccination of immunocompetent individuals is generally not recommended (ACIP [Robinson 2016]).

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.

Administration

Administer SubQ or IM (deltoid muscle or lateral midthigh). Do not inject IV; avoid intradermal administration (may cause severe local reactions). To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (NCIRD/ACIP 2011). 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 (NCIRD/ACIP 2011).

Compatibility

Do not mix with other vaccines or injections. Separate needles and syringes should be used for each injection.

Storage

Store at 2°C to 8°C (36°F to 46°F).

Drug Interactions

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

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Zoster Vaccine: Pneumococcal Polysaccharide Vaccine (23-Valent) may diminish the therapeutic effect of Zoster Vaccine. Monitor therapy

Adverse Reactions

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967 or online at https://vaers.hhs.gov/esub/index. In Canada, adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018).

Frequency not defined.

Central nervous system: Chills, Guillain-Barré syndrome, fever ≤102°F*, fever >102°F, headache, malaise, pain, radiculoneuropathy, seizure (febrile)

Dermatologic: Angioneurotic edema, cellulitis, rash, urticaria

Gastrointestinal: Nausea, vomiting

Hematologic: Hemolytic anemia (in patients with other hematologic disorders), leukocytosis, thrombocytopenia (in patients with stabilized ITP)

Local: Injection site reaction* (erythema, induration, swelling, soreness, warmth); peripheral edema in injected extremity

Neuromuscular & skeletal: Arthralgia, arthritis, limb mobility decreased, myalgia, paresthesia, weakness

Miscellaneous: Anaphylactoid reaction, C-reactive protein increased, lymphadenitis, lymphadenopathy, serum sickness

*Reactions most commonly reported in clinical trials.

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 (NCIRD/ACIP 2011).

• 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 (NCIRD/ACIP 2011).

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. Consider deferring 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) (NCIRD/ACIP 2011).

• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia) and patients on anticoagulant therapy; 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 (NCIRD/ACIP 2011).

• 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:

• 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 (NCIRD/ACIP 2011). 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: Use with caution in severely immunocompromised patients; patients who will be receiving immunosuppressive therapy (including Hodgkin disease, cancer chemotherapy, or transplantation) should be vaccinated at least 2 weeks prior to the initiation of therapy. Immune responses may be impaired for several months following intensive immunosuppressive therapy (up to 2 years in Hodgkin disease patients). In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines (IDSA [Rubin 2014]; NCIRD/ACIP 2011); inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (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 ACIP Recommended Adult Immunization Schedule (ACIP [Kim 2016]). 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 (NCIRD/ACIP 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination 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 (NCIRD/ACIP 2011).

Monitoring Parameters

Monitor for syncope for 15 minutes following administration (NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Risk Factor

C

Pregnancy Considerations

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 (NCIRD/ACIP 2011).

Patient Education

• 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.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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