Version July 2025
Note: According to the Advisory Committee on Immunization Practices, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (Ref).
Pneumococcal disease prevention: PCV21: IM: 0.5 mL as a single dose; see the following recommendations based on age, prior pneumococcal vaccination, and comorbid conditions/risk factors (Ref). For additional guidance, the CDC recommends using the PneumoRecs VaxAdvisor (mobile app or web version https://www2a.cdc.gov/vaccines/m/pneumo/agegroup.html).
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Prior pneumococcal vaccination |
Option A |
Option B |
|---|---|---|
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a Includes alcohol use disorder, chronic heart/liver/lung disease, cigarette smoking, diabetes mellitus. | ||
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b Vaccine abbreviations: Pneumococcal conjugate vaccine 20-valent = PCV20; Pneumococcal conjugate vaccine 21-valent = PCV21; Pneumococcal conjugate vaccine 15-valent = PCV15; Pneumococcal conjugate vaccine 13-valent = PCV13; Pneumococcal polysaccharide vaccine 23-valent = PPSV23. Refer to individual monographs for additional information. | ||
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c Also applies to patients who previously received PCV7 (at any age) but no other pneumococcal vaccines or unknown vaccination status. | ||
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d If PPSV23 is not available, then PCV20 or PCV21 may be used. | ||
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e Review recommendations again when patient turns 50 years of age. | ||
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Nonec |
PCV20 or PCV21 |
PCV15 followed by PPSV23d ≥1 year later |
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PPSV23 only |
PCV20 or PCV21 administered ≥1 year after PPSV23 |
PCV15 administered ≥1 year after PPSV23 |
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PCV13 only |
PCV20 or PCV21 administered ≥1 year after PCV13 | |
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PCV13 and PPSV23 |
No additional pneumococcal vaccine at this time.e | |
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PCV15 only |
PPSV23 ≥1 year after PCV15 | |
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PCV20 or PCV21 only |
No additional pneumococcal vaccine at this time. | |
|
Prior pneumococcal vaccination |
Option A |
Option B |
|---|---|---|
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a Includes asplenia (congenital or acquired), chronic renal failure, generalized malignancy, HIV infection, Hodgkin disease, immunodeficiencies (congenital or acquired), immunosuppression (iatrogenic, including immunosuppressive therapies), leukemia, lymphoma, multiple myeloma, nephrotic syndrome, sickle cell disease and other hemoglobinopathies, solid organ transplant. Excludes hematopoietic cell transplant (HCT). | ||
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b Vaccine abbreviations: Pneumococcal conjugate vaccine 20-valent = PCV20; Pneumococcal conjugate vaccine 21-valent = PCV21; Pneumococcal conjugate vaccine 15-valent = PCV15; Pneumococcal conjugate vaccine 13-valent = PCV13; Pneumococcal polysaccharide vaccine 23-valent = PPSV23. Refer to individual monographs for additional information. | ||
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c Also applies to patients who previously received PCV7 (at any age) but no other pneumococcal vaccines or unknown vaccination status. | ||
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d If PPSV23 is not available, then PCV20 or PCV21 may be used. | ||
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e Review recommendations again when patient turns 50 years of age. | ||
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Nonec |
PCV20 or PCV21 |
PCV15 followed by PPSV23d ≥8 weeks later |
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PPSV23 only |
PCV20 or PCV21 administered ≥1 year after PPSV23 |
PCV15 administered ≥1 year after PPSV23 |
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PCV13 only |
PCV20 or PCV21 administered ≥1 year after PCV13 | |
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PCV13 and 1 dose of PPSV23 |
PCV20 or PCV21 administered ≥5 years after last pneumococcal vaccine | |
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PCV13 and 2 doses of PPSV23 |
PCV20 or PCV21 administered ≥5 years after last pneumococcal vaccine |
No additional pneumococcal vaccine at this time.e |
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PCV15 only |
PPSV23 administered ≥8 weeks later after PCV15 | |
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PCV20 or PCV21 only |
No additional pneumococcal vaccine at this time. | |
|
Prior pneumococcal vaccination |
Option A |
Option B |
|---|---|---|
|
a Vaccine abbreviations: Pneumococcal conjugate vaccine 20-valent = PCV20; Pneumococcal conjugate vaccine 21-valent = PCV21; Pneumococcal conjugate vaccine 15-valent = PCV15; Pneumococcal conjugate vaccine 13-valent = PCV13; Pneumococcal polysaccharide vaccine 23-valent = PPSV23. Refer to individual monographs for additional information. | ||
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b Also applies to patients who previously received PCV7 (at any age) but no other pneumococcal vaccines or unknown vaccination status. | ||
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c If PPSV23 is not available, then PCV20 or PCV21 may be used. | ||
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d Review recommendations again when patient turns 50 years of age. | ||
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Noneb |
PCV20 and PCV21 |
PCV15 followed by PPSV23c ≥8 weeks later |
|
PPSV23 only |
PCV20 and PCV21 administered ≥1 year after PPSV23 |
PCV15 administered ≥1 year after PPSV23 |
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PCV13 only |
PCV20 and PCV21 administered ≥1 year after PCV13 | |
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PCV13 and 1 dose of PPSV23 |
PCV20 and PCV21 administered ≥5 years after last pneumococcal vaccine | |
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PCV15 only |
PPSV23 administered ≥8 weeks after PCV15d | |
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PCV20 and PCV21 only |
No additional pneumococcal vaccine at this time. | |
|
Prior pneumococcal vaccination |
Option A |
Option B |
|---|---|---|
|
a Vaccine abbreviations: Pneumococcal conjugate vaccine 20-valent = PCV20; Pneumococcal conjugate vaccine 21-valent = PCV21; Pneumococcal conjugate vaccine 15-valent = PCV15; Pneumococcal conjugate vaccine 13-valent = PCV13; Pneumococcal polysaccharide vaccine 23-valent = PPSV23. Refer to individual monographs for additional information. | ||
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b Also applies to patients who previously received PCV7 (at any age) but no other pneumococcal vaccines or unknown vaccination status. | ||
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c If PPSV23 is not available, then PCV20 or PCV21 may be used. | ||
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d Consider shorter interval (minimum of 8 weeks) for those with an immunocompromising condition, cochlear implant, or cerebrospinal fluid leak. | ||
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Noneb |
PCV20 and PCV21 |
PCV15 followed by PPSV23c ≥1 year laterd |
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PPSV23 only (at any age) |
PCV20 and PCV21 administered ≥1 year after PPSV23 |
PCV15 administered ≥1 year after PPSV23 |
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PCV13 only (at any age) |
PCV20 and PCV21 administered ≥1 year after PCV13 | |
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PCV13 (at any age) and PPSV23 at <65 years of age |
PCV20 and PCV21 administered ≥5 years after last pneumococcal vaccination | |
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: PCV21: IM: 0.5 mL as a single dose; see the following recommendations based on prior pneumococcal vaccination and comorbid conditions/risk factor (Ref). For additional guidance, the CDC recommends using the PneumoRecs VaxAdvisor (mobile app or web version https://www2a.cdc.gov/vaccines/m/pneumo/agegroup.html).
|
Prior pneumococcal vaccination |
Option A |
Option B |
|---|---|---|
|
a Vaccine abbreviations: Pneumococcal conjugate vaccine 20-valent = PCV20; Pneumococcal conjugate vaccine 21-valent = PCV21; Pneumococcal conjugate vaccine 15-valent = PCV15; Pneumococcal conjugate vaccine 13-valent = PCV13; Pneumococcal polysaccharide vaccine 23-valent = PPSV23. Refer to individual monographs for additional information. | ||
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b Also applies to patients who previously received PCV7 at any age but no other pneumococcal vaccines or unknown vaccination status. | ||
|
c If PPSV23 is not available, then PCV20 or PCV21 may be used. | ||
|
d Consider shorter interval (minimum of 8 weeks) for those with an immunocompromising condition, cochlear implant, or cerebrospinal fluid (CSF) leak. | ||
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Noneb |
PCV20 or PCV21 |
PCV15 followed by PPSV23c ≥1 year laterd |
|
PPSV23 only (at any age) |
PCV20 or PCV21 administered ≥1 year after PPSV23 |
PCV15 administered ≥1 year after PPSV23 |
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PCV13 only (at any age) |
PCV20 or PCV21 administered ≥1 year after PCV13 | |
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PCV13 (at any age) and PPSV23 at <65 years of age |
PCV20 or PCV21 administered ≥5 years after last pneumococcal vaccination | |
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PCV13 (at any age) and PPSV23 at ≥65 years of age |
May administer PCV20 or PCV21 ≥5 years after last pneumococcal vaccine (per shared clinical decision-making) | |
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PCV15 |
PPSV23 administered ≥1 year after PCV15d | |
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PCV20 or PCV21 |
No additional pneumococcal vaccine at this time. | |
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.
>10%:
Local: Erythema at injection site (5% to 16%), pain at injection site (36% to 73%), swelling at injection site (5% to 14%)
Nervous system: Fatigue (14% to 41%), headache (7% to 30%)
Neuromuscular & skeletal: Myalgia (6% to 17%)
Miscellaneous: Fever (≤4%)
<1%:
Hypersensitivity: Hypersensitivity reaction (grade 3)
Local: Cellulitis at injection site (grade 4)
Hypersensitivity (eg, anaphylaxis) to pneumococcal conjugate vaccine, any component of the formulation, or to diphtheria toxoid.
Concerns related to adverse effects:
• Anaphylactoid/Hypersensitivity reactions: Immediate treatment (including injectable epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 2023]).
• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis, tendinopathy), 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 2023]).
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. Postpone 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 2023]).
• 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 2023]).
Concurrent drug therapy issues:
• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2023]).
• Vaccines: In order to maximize vaccination rates, the Advisory Committee on Immunization Practices recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or nonlive) for which a person is eligible at a single visit, unless contraindications exist (ACIP [Kroger 2023]).
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. Nonlive vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; nonlive vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2023]; IDSA [Rubin 2014]).
• Older adult: Opsonophagocytic activity responses (used to assess vaccine-induced antibodies) were lower in adults ≥65 years of age compared to adults <65 years of age.
Other warnings/precautions:
• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2023]). 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 is improved by administering the vaccine at the recommended dose, route, and interval (ACIP [Kroger 2023]).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Intramuscular [preservative free]:
Capvaxive: 0.5 mL (0.5 mL)
No
Solution Prefilled Syringe (Capvaxive Intramuscular)
0.5 mL (per 0.5 mL): $345.15
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Prefilled Syringe, Intramuscular:
Capvaxive: 0.5 mL (0.5 mL)
IM: Administer by IM injection into the deltoid muscle; the anterolateral thigh may also be used (ACIP [Kroger 2023]). Use proper injection technique 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). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope-related injuries, adults should be vaccinated while seated or lying down (ACIP [Kroger 2023]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, vaccine information statement 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 IM injection, the Advisory Committee on Immunization Practices recommends that the vaccine should be administered IM 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, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (≤23-gauge) 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 2023]).
In the United States, 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 https://www.cdc.gov/vaccines/hcp/vis/vis-statements/pcv.html.
Invasive Streptococcus pneumoniae disease prevention: Active immunization in persons ≥18 years of age for the prevention of invasive disease caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B. (Note: The Canadian product also includes serotype 6C).
Pneumococcal pneumonia prevention: Active immunization in persons ≥18 years of age for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B.
Advisory Committee on Immunization Practices recommendations:
The Advisory Committee on Immunization Practices (ACIP) recommends routine pneumococcal vaccination in the following adult persons (CDC/ACIP [Kobayashi 2024]; CDC/ACIP [Kobayashi 2025]).
Adults 19 to 49 years of age with any of the following underlying medical conditions or risk factors: Alcohol use disorder, 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, immunocompromising conditions (eg, asplenia [congenital or acquired], 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 [including long-term systemic corticosteroid treatment, radiation therapy], leukemia, lymphoma, multiple myeloma, nephrotic syndrome, sickle cell disease or other hemoglobinopathies, solid organ transplant).
Adults ≥50 years of age (pneumococcal conjugate vaccine-naive or vaccination status unknown).
Note: PCV21 includes 8 serotypes not included in PCV15 or PCV20; however, it does not include serotype 4 which has caused high percentages (≥30%) of invasive pneumococcal disease in certain adult populations in the western United States. CDC and ACIP monitoring of the public health impact of the pneumococcal conjugate vaccines will guide future recommendations.
PCV21 (pneumococcal 21-valent conjugate vaccine) may be confused with PCV13 (pneumococcal 13-valent conjugate vaccine), PCV15 (pneumococcal 15-valent conjugate vaccine), PCV20 (pneumococcal 20-valent conjugate vaccine), and PPSV23 (pneumococcal 23-valent polysaccharide vaccine).
Pneumococcal 21-valent conjugate vaccine (Capvaxive, PCV21) may be confused with pneumococcal 13-valent conjugate vaccine (Prevnar 13, PCV13); pneumococcal 15-valent conjugate vaccine (Vaxneuvance, PCV15); pneumococcal 20-valent conjugate vaccine (Prevnar 20, PCV20); and pneumococcal 23-valent polysaccharide vaccine (Pneumovax 23).
PCV (pneumococcal conjugate vaccine) may be confused with MCV (meningococcal ACWY conjugate vaccine, MCV4 is the correct abbreviation).
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetaminophen: May decrease therapeutic effects 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
Anti-CD20 B-Cell Depleting Therapies: May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation or 6 months after anti-CD20 B-cell depleting therapies. If vaccinated prior to B cell recovery, consider assessing immune response to vaccination. Risk D: Consider Therapy Modification
Atidarsagene Autotemcel: May increase adverse/toxic effects of Vaccines. Atidarsagene Autotemcel may decrease therapeutic effects of Vaccines. Risk X: Avoid
Cladribine: May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete Risk D: Consider Therapy Modification
Corticosteroids (Systemic): May decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Dinutuximab Beta: May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Risk X: Avoid
Elivaldogene Autotemcel: May increase adverse/toxic effects of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may decrease therapeutic effects 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
Fingolimod: May decrease therapeutic effects of Vaccines (Non-Live/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 decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Immunosuppressants (Miscellaneous Oncologic Agents): May decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Immunosuppressants (Therapeutic Immunosuppressant Agents): May decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Methotrexate: May decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor
Propacetamol: May decrease therapeutic effects 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
Siponimod: May decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Avoid administration of non-live/inactivated/non-replicating vaccines during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Risk D: Consider Therapy Modification
Teplizumab: May decrease therapeutic effects 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 decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Vaccination with non-live/inactivated/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
Maternal administration of nonlive bacterial vaccines has not been shown to cause increased risks to the fetus (ACIP [Kroger 2023]). Pneumococcal vaccines may be administered during pregnancy in persons at increased risk of severe disease due to underlying medical conditions (ACOG 2018; ACOG 2024).
It is not known if the components of this vaccine are present in breast milk.
According to the manufacturer, the decision to breastfeed 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 the breastfed infant or mother (ACIP [Kroger 2023]).
Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]).
Promotes active immunization against pneumonia and invasive disease caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B, each of which are individually conjugated to CRM197 protein. (Note: The Canadian product also includes serotype 6C).
Onset: Immune response was elicited by 30 days postvaccination (Platt 2023).
