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 the Advisory Committee on Immunization Practices (ACIP), doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (ACIP [Kroger 2022]).
Primary immunization: Note: May be used to complete a series initiated with a lower valency pneumococcal conjugate vaccine (eg, 13-valent pneumococcal conjugate vaccine [PCV13]). Preterm infants should be vaccinated according to their chronological age from birth.
Infants ≥6 weeks and Children ≤15 months: IM: 0.5 mL per dose for a total of 4 doses given at 2, 4, 6, and 12 through 15 months of age. The first dose may be given as young as 6 weeks of age.
Catch-up immunization:
Patients initiating new vaccine series:
Infants 7 to <12 months: IM: 0.5 mL per dose for a total of 3 doses; administer the second dose ≥4 weeks after the first; administer the third dose ≥8 weeks after the second dose and after 1 year of age (ACIP/CDC [Kobayashi 2022b]; manufacturer's labeling).
Children <2 years: IM: 0.5 mL per dose for 2 doses administered ≥8 weeks apart (ACIP/CDC [Kobayashi 2022b]; manufacturer's labeling).
Children 2 to <6 years:
Patients without any conditions that increase the risk for pneumococcal disease (ie, healthy children): IM: 0.5 mL as a single dose (ACIP/CDC [Kobayashi 2022b]; manufacturer's labeling).
Patients with conditions that increase the risk for pneumococcal disease: IM: 0.5 mL per dose for 2 doses administered ≥8 weeks apart. Note: If PPSV23 was previously administered, initiate pneumococcal conjugate vaccination ≥8 weeks after PPSV23 dose (ACIP/CDC [Kobayashi 2022b]).
Children ≥6 years and Adolescents: Patients with an immunocompromising condition, cochlear implant, or cerebrospinal fluid leak: IM: 0.5 mL as a single dose (even if PCV7 was previously administered). Note: If PPSV23 was previously administered, initiate pneumococcal conjugate vaccination ≥8 weeks after PPSV23 dose. Although FDA approved for a single catch-up dose in healthy patients 6 to 17 years of age, catch-up vaccination is not currently recommended for this population (ACIP/CDC [Kobayashi 2022b]).
Patients who previously received an incomplete series with another pneumococcal conjugate vaccine (eg, PCV13): Note: Either PCV13 or PCV15 may be used to complete the series; if PPSV23 has been administered, initiate pneumococcal conjugate vaccination ≥8 weeks after PPSV23 dose (ACIP/CDC [Kobayashi 2022b]).
Infants ≥2 months and Children <2 years: IM: 0.5 mL per dose for a total of 1 to 3 additional doses; refer to current ACIP recommendations for specific scheduling and timing of doses based on patient age and previous doses received (ACIP/CDC [Kobayashi 2022b]).
Children 2 to <6 years (ACIP/CDC [Kobayashi 2022b]):
Patients without any conditions that increase the risk for pneumococcal disease (ie, healthy children):
Children 2 to <5 years: IM: 0.5 mL for a single dose administered ≥8 weeks after most recent pneumococcal conjugate vaccine dose.
Children ≥5 years: No additional doses recommended.
Patients with conditions that increase the risk for pneumococcal disease: Children 2 to <6 years: IM: 0.5 mL per dose for 1 to 2 additional doses; refer to current ACIP recommendations for specific scheduling and timing of doses based on previous number of doses received.
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 conjugate vaccine (15-valent) (PCV15): Drug information")
Pneumococcal disease prevention: IM: 0.5 mL as a single dose.
CDC/ACIP recommendations: Adults 19 to 64 years of age with specified underlying medical conditions (CDC/ACIP [Kobayashi 2022a]):
Primary immunization: IM: 0.5 mL as a single dose followed by PPSV23 ≥1 year later. Note: A shorter interval (eg, ≥8 weeks) may be considered for persons with immunocompromising conditions, cochlear implant, or cerebrospinal fluid leak.
Previously received only PPSV23: May administer PCV15 (or PCV20) ≥1 year after last PPSV23 dose; repeat dose of PPSV23 is not needed after PCV15.
Previously received PCV13: Vaccination with PCV15 not currently recommended. (See PPSV23 or PCV20 monograph for information regarding completion of pneumococcal series.)
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Prefilled Syringe, Intramuscular:
Vaxneuvance: 2 mcg each of capsular polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4 mcg of capsular polysaccharide for serotype 6B [conjugated to CRM197 protein 30 mcg] per 0.5 mL (0.5 mL)
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Prefilled Syringe, Intramuscular:
Vaxneuvance: 2 mcg each of capsular polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4 mcg of capsular polysaccharide for serotype 6B [conjugated to CRM197 protein 30 mcg] per 0.5 mL (0.5 mL)
In the United States, the appropriate CDC-approved Vaccine Information Statement (VIS) must be provided to the patient/caregiver before administering each dose of this vaccine; the VIS edition date and date it was provided to the patient/caregiver should be recorded as required by US law. VIS is available at https://www.cdc.gov/vaccines/hcp/vis/vis-statements/pcv.html.
Parenteral: IM: Hold syringe horizontally and shake well prior to use; do not use if an opalescent suspension does not form. Administer IM into the anterolateral thigh or deltoid muscle, as appropriate for age (ACIP [Kroger 2022]). 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, adolescents should be vaccinated while seated or lying down (ACIP [Kroger 2022]). 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 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 2022]).
IM: Hold syringe horizontally and shake well prior to use; do not use if an opalescent suspension does not form. Administer IM into the deltoid muscle (ACIP [Kroger 2022]). 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, patients should be vaccinated while seated or lying down (ACIP [Kroger 2022]). 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 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 2022]).
Store intact vial refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light.
Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F (FDA approved in ages ≥6 weeks and adults).
Advisory Committee on Immunization Practices (ACIP) Recommendations:
Per ACIP, 13-valent pneumococcal conjugate vaccine (PCV13) and 15-valent pneumococcal conjugate vaccine (PCV15) can be used interchangeably in pediatric patients; either is acceptable for use according to the following recommendations (CDC/ACIP [Kobayashi 2022b]).
Vaccination with pneumococcal conjugate vaccine (PCV13 or PCV15) is recommended for the following (CDC/ACIP [Kobayashi 2022b]):
• All infants and children 2 to 59 months of age
• Previously unvaccinated children 60 months (5 years) to 71 months (<6 years) of age with conditions that increase the risk for pneumococcal disease, including the following:
- Chronic heart disease (particularly cyanotic congenital heart disease and cardiac failure); chronic lung disease (including asthma if treated with high-dose corticosteroids); diabetes mellitus; cerebrospinal fluid leak; cochlear implant
- Immunocompromising conditions, including chronic renal failure or nephrotic syndrome, congenital or acquired asplenia or splenic dysfunction, sickle cell disease or other hemoglobinopathies, congenital or acquired immunodeficiency (including B or T cell deficiency, complement deficiencies [particularly C1, C2, C3, and C4 deficiency], and phagocytic disorders; excluding chronic granulomatous disease), HIV infection, solid organ transplant, or other diseases treated with immunosuppressive drugs or radiation therapy including, but not limited to, malignant neoplasms, leukemia, lymphoma, and Hodgkin disease
• Previously unvaccinated children ≥6 years and adolescents <19 years of age with any of the following:
- Cochlear implant or cerebrospinal fluid leak
- Immunocompromising conditions, including chronic renal failure or nephrotic syndrome, congenital or acquired asplenia or splenic dysfunction, sickle cell disease or other hemoglobinopathies, congenital or acquired immunodeficiency (including B or T cell deficiency, complement deficiencies [particularly C1, C2, C3, and C4 deficiency], and phagocytic disorders; excluding chronic granulomatous disease), HIV infection, solid organ transplant, or other diseases treated with immunosuppressive drugs or radiation therapy including, but not limited to, malignant neoplasms, leukemia, lymphoma, and Hodgkin disease
PCV15 (pneumococcal 15-valent conjugate vaccine) may be confused with PCV13 (pneumococcal 13-valent conjugate vaccine), PCV20 (pneumococcal 20-valent conjugate vaccine), and PPSV23 (pneumococcal 23-valent polysaccharide vaccine).
Pneumococcal 15-Valent Conjugate Vaccine (Vaxneuvance, PCV15) may be confused with Pneumococcal 13-Valent Conjugate Vaccine (Prevnar 13), 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 ACYW conjugate vaccine, MCV4 is the correct abbreviation).
PCV (pneumococcal conjugate vaccine) may be confused with PPD (purified protein derivative tuberculin test).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for infants, children, adolescents, and adults, unless otherwise indicated.
>10%:
Gastrointestinal: Decreased appetite (infants, children <2 years: 14% to 23%; children ≥2 years, adolescents: 2%)
Local: Erythema at injection site (8% to 28%), induration at injection site (infants, children, adolescents: 7% to 17%), pain at injection site (19% to 76%), swelling at injection site (11% to 22%)
Nervous system: Drowsiness (infants, children <2 years: 22% to 48%; children ≥2 years, adolescents: 3%), fatigue (children, adolescents, adults: 16% to 34%), headache (children, adolescents, adults: 12% to 27%), irritability (infants, children <2 years: 33% to 63%; children ≥2 years, adolescents: 3%)
Neuromuscular & skeletal: Arthralgia (adults: 6% to 13%), myalgia (children, adolescents, adults: 16% to 29%)
Miscellaneous: Fever (infants and children <2 years: 11% to 22%; children ≥2 years, adolescents, adults: ≤4%)
1% to 10%:
Dermatologic: Urticaria (infants, children, adolescents: 1% to 3%)
Local: Injection-site pruritus (adults: 3%)
<1%:
Local: Urticaria at injection site (infants, children <2 years)
Nervous system: Febrile seizure (infants)
Frequency not defined: Respiratory: Apnea (premature infants)
Severe hypersensitivity (eg, anaphylaxis) to pneumococcal conjugate vaccine, any component of the formulation, or to diphtheria toxoid.
Concerns related to adverse effects:
• 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 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]).
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: To maximize vaccination rates, the Advisory Committee on Immunization Practices (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]).
Special populations:
• Altered immunocompetence: Consider deferring vaccination 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 (ACIP [Kroger 2022]; IDSA [Rubin 2014]). 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]).
• Premature infants: Apnea following IM vaccination has been observed in some preterm infants; consider clinical status implications.
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 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).
• Appropriate use: Specific recommendations for use of vaccines 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 Infectious Diseases Society of America (IDSA [Rubin 2014]).
• 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]).
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.
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
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
Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of 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 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
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
Adverse fetal effects were not observed in animal developmental toxicity studies.
Maternal administration of non-live 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 2022a]), pneumococcal vaccines may be administered during pregnancy in persons at increased risk of severe disease due to underlying medical conditions (ACOG 2018; ACOG 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.
Promotes active immunization against invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, each of which are individually conjugated to CRM197 protein.
Onset: Immune response was elicited by 30 days postvaccination.
Suspension Prefilled Syringe (Vaxneuvance Intramuscular)
0.5 mL (per 0.5 mL): $259.15
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