Pneumococcal disease prevention:
CDC/ACIP recommendations: Adults 19 to 64 years of age with specified underlying medical conditions (CDC/ACIP [Kobayashi 2022]):
Primary immunization: IM, SUBQ: 0.5 mL per dose according to the following recommendations:
Pneumococcal vaccine-naive or vaccination status is unknown: Administer PCV15 or PCV20. If PCV20 is used, then PPSV23 is not needed. If PCV15 is administered, follow with a single dose of pneumococcal polysaccharide vaccine (PPSV23) ≥1 year later. Note: A shorter interval (eg, ≥8 weeks) may be considered for persons with immunocompromising conditions, cochlear implant, or cerebrospinal fluid (CSF) leak.
Previously received only PPSV23 but no pneumococcal conjugate vaccine: No additional PPSV23 doses needed for primary immunization; may administer PCV15 or PCV20 ≥1 year after the last PPSV23 dose was received.
Previously received PCV13 but not PPSV23: Administer PPSV23 ≥8 weeks after PCV13 for patients with cochlear implant, CSF leak, or immunocompromising condition. For patients with an immunocompromising condition, administer a second dose of PPSV23 ≥5 years after the previous dose of PPSV23. Note: Once the patient turns 65 years of age and ≥5 years have passed since the last dose of PPSV23, a final dose of PPSV23 should be given.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
(For additional information see "Pneumococcal polysaccharide vaccine (23-valent) (PPSV23): Pediatric drug information")
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 2021]).
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.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Pneumococcal disease prevention :
CDC/ACIP recommendations (CDC/ACIP [Kobayashi 2022]):
Primary immunization: IM, SUBQ: 0.5 mL according to the following recommendations:
Pneumococcal vaccine-naive or vaccination status is unknown: Administer PCV15 or PCV20. If PCV20 is used, then PPSV23 is not needed. If PCV15 is administered, follow with a single dose of PPSV23 ≥1 year later. Note: A shorter interval (eg, ≥8 weeks) may be considered for persons with immunocompromising conditions, cochlear implant, or CSF leak.
Previously received only PPSV23 but no pneumococcal conjugate vaccine: No additional PPSV23 doses needed; may administer PCV15 or PCV20 ≥1 year after the last PPSV23 dose was received.
Previously received PCV13 but not PPSV23: Administer PPSV23 ≥1 year after PCV13.
Patients with an immunocompromising condition who received PCV13 and PPSV23 at age <65 years: Administer a final dose of PPSV23 ≥5 years after the previous dose of PPSV23 once the patient turns 65 years of age.
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]
No
In the US, the appropriate CDC-approved Vaccine Information Statement (VIS) should be provided to the patient/caregiver before administering each dose of this vaccine. If purchased under CDC contract, the VIS must be provided and the VIS edition date and date it was provided to the patient/caregiver should be recorded. VIS is available at http://www.cdc.gov/vaccines/hcp/vis/vis-statements/ppv.html.
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, patients should be vaccinated while seated or lying down (ACIP [Kroger 2022]). If purchased under CDC contract, US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
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 2022]).
Administer SubQ or IM either the anterolateral aspect of the thigh or the deltoid muscle; not for IV or intradermal administration. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (ACIP [Kroger 2021]). To prevent syncope-related injuries, adolescents should be vaccinated while seated or lying down (ACIP [Kroger 2021]). If purchased under CDC contract, US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.
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 2021]).
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.
Advisory Committee on Immunization Practices recommendations:
The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination in the following persons (ACIP/CDC [Kobayashi 2022]; ACIP [Kobayashi 2015]; CDC/ACIP [Matanock 2019]; CDC/ACIP [Nuorti 2010]):
Children ≥2 years of age and adolescents 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
Immunocompromised children ≥2 years of age and adolescents 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)
Adults 19 to 64 years of age with any of the following underlying medical conditions or risk factors, who received PCV15: alcoholism, chronic heart disease (including heart failure, cardiomyopathies), chronic liver disease, chronic lung disease (including chronic obstructive pulmonary disease, emphysema, asthma), cigarette smoking, diabetes mellitus, cochlear implant, cerebrospinal fluid leaks, asplenia (congenital or acquired), sickle cell disease or other hemoglobinopathies, immunocompromising conditions (eg, chronic renal failure, congenital or acquired immunodeficiency [including B- or T-cell deficiency, complement deficiencies and phagocytic disorders; excluding chronic granulomatous disease], malignancy, HIV infection, Hodgkin disease, iatrogenic immunosuppression requiring immunosuppressive drugs [including long-term systemic corticosteroids, radiation therapy], leukemia, lymphoma, multiple myeloma, nephrotic syndrome, solid organ transplant)
Adults ≥65 years of age (unless they are vaccinated with PCV20)
Pneumococcal 23-valent polysaccharide vaccine (Pneumovax 23) may be confused with pneumococcal 13-valent conjugate vaccine (Prevnar 13), pneumococcal 15-valent conjugate vaccine (Vaxneuvance, PCV15), and pneumococcal 20-valent conjugate vaccine (Prevnar 20, PCV20).
PPSV23 (pneumococcal 23-valent polysaccharide vaccine) may be confused with PCV13 (pneumococcal 13-valent conjugate vaccine), PCV15 (pneumococcal 15-valent conjugate vaccine), and PCV20 (pneumococcal 20-valent conjugate vaccine).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Local: Erythema at injection site (16% to 35%), induration at injection site (≤40%), local soreness/soreness at injection site (≤77%), pain at injection site (≤77%), swelling at injection site (≤40%; including peripheral edema in injected extremity), tenderness at injection site (≤77%)
Nervous system: Fatigue (≤18%), headache (18%)
Neuromuscular & skeletal: Asthenia (≤18%), myalgia (12% to 17%)
1% to 10%:
Dermatologic: Ecchymoses (1%), pruritus (≤2%)
Gastrointestinal: Diarrhea (1%), dyspepsia (1%), nausea (2%)
Nervous system: Chills (3% to 8%)
Neuromuscular & skeletal: Neck pain (2%)
Respiratory: Upper respiratory tract infection (3%)
Miscellaneous: Fever (1% to 2%)
Postmarketing:
Dermatologic: Cellulitis, erythema multiforme, skin rash, urticaria
Gastrointestinal: 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)
Hypersensitivity: Angioedema, nonimmune anaphylaxis, serum sickness
Local: Tissue necrosis at injection site, warm sensation at injection site
Nervous system: Guillain-Barré syndrome, malaise, nerve root disorder, paresthesia
Neuromuscular & skeletal: Arthralgia, arthritis, decreased range of motion (limb)
Miscellaneous: Febrile seizure
Severe allergic reaction (eg, anaphylactic/anaphylactoid reaction) to pneumococcal vaccine or any component of the formulation
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 2022]).
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis, tendinitis) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).
• 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 2022]).
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 2022]).
• 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 2022]).
• 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 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 2022]).
• 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 2022]). 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 2022]; (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]).
• Older adults: 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 2022]). 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 2022]).
Not recommended for use in infants and children <2 years of age.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
Corticosteroids (Systemic): May diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination
Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). 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. Risk D: Consider therapy modification
Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Methotrexate: May diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Pneumococcal Conjugate Vaccine (13-Valent): Pneumococcal Polysaccharide Vaccine (23-Valent) may diminish the therapeutic effect of Pneumococcal Conjugate Vaccine (13-Valent). Management: Administer PCV13 prior to administration of PPSV23. Immunocompetent patient with comorbidities: age 24 months to 71 months, separate by 8 weeks; age 65 years or older, separate by 1 year. Immunocompromised patient over age 24 months, separate by 8 weeks. Risk D: Consider therapy modification
Pneumococcal Conjugate Vaccine (20-Valent): Pneumococcal Polysaccharide Vaccine (23-Valent) may diminish the therapeutic effect of Pneumococcal Conjugate Vaccine (20-Valent). Risk C: Monitor therapy
Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification
RiTUXimab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of rituximab when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 6 months after therapy is complete. Risk D: Consider therapy modification
Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider therapy modification
Teplizumab: May diminish the therapeutic effect of Pneumococcal Vaccines. Management: Vaccination with inactivated vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during therapy, or for 6 weeks after completion of therapy. See full mono for recommendations for number, order, and timing of vaccines. Risk D: Consider therapy modification
Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification
Zoster Vaccine (Live/Attenuated): Pneumococcal Polysaccharide Vaccine (23-Valent) may diminish the therapeutic effect of Zoster Vaccine (Live/Attenuated). Risk C: Monitor therapy
Animal developmental toxicity studies have not been conducted.
Maternal administration of nonlive bacterial vaccines has not been shown to cause increased risks to the fetus (ACIP [Kroger 2022]). Although specific recommendations for vaccination of pregnant patients is not available (CDC/ACIP [Kobayashi 2022]), pneumococcal vaccines may be administered during pregnancy in persons at increased risk of severe disease due to underlying medical conditions (ACOG 2018; ACOG 2022).
It is not known if the components of this vaccine are present in breast milk.
According to the manufacturer, the decision to continue or discontinue breastfeeding following immunization should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of vaccination to the mother. Maternal administration of nonlive vaccines has not been shown to affect the safety of breastfeeding for the mother or the infant. Breastfeeding infants should be vaccinated according to the recommended schedules (ACIP [Kroger 2022]).
Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2022]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.
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).
Onset: Immunity develops within approximately 2 to 3 weeks after vaccination (Pink Book [Atkinson 2012]).
Duration: 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]).
Injection (Pneumovax 23 Injection)
25 mcg/0.5 mL (per 0.5 mL): $140.50
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