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Pneumococcal conjugate vaccine (13-valent) (PCV13): Drug information

Pneumococcal conjugate vaccine (13-valent) (PCV13): Drug information
(For additional information see "Pneumococcal conjugate vaccine (13-valent) (PCV13): Pediatric drug information" and see "Pneumococcal conjugate vaccine (13-valent) (PCV13): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Prevnar 13
Brand Names: Canada
  • Prevnar 13
Pharmacologic Category
  • Vaccine;
  • Vaccine, Inactivated (Bacterial)
Dosing: Adult
Pneumococcal disease prevention

Pneumococcal disease prevention: IM: 0.5 mL as a single dose. Note: Current CDC/ACIP pneumococcal vaccination guidelines recommend alternate pneumococcal conjugate vaccine options; see PCV15 and PCV20 monographs (CDC/ACIP [Kobayashi 2022a]).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Pneumococcal conjugate vaccine (13-valent) (PCV13): Pediatric drug information")

Note: Consult CDC/ACIP annual immunization schedules or National Advisory Committee on Immunization (NACI) guidelines (Canada) 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 2022]).

Primary immunization

Primary immunization:

Note: May be used interchangeably with 15-valent pneumococcal conjugate vaccine CDC/ACIP [Kobayashi 2022b]). 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 administered at 2, 4, 6, and 12 through 15 months of age. The first dose may be administered as young as 6 weeks of age.

Canadian recommendations: Healthy infants: IM: 0.5 mL per dose. Routine immunization may be provided as a 4-dose schedule at 2, 4, 6, and 12 to 15 months of age, or as a 3-dose schedule at 2, 4, and 12 months of age. For infants at high risk of invasive pneumococcal disease due to an underlying medical condition, the 4-dose schedule should be used (NACI 2016).

Catch-up immunization

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, 13-valent pneumococcal conjugate vaccine [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.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Pneumococcal disease prevention: IM: 0.5 mL as a single dose. Note: Current CDC/ACIP pneumococcal vaccination guidelines recommend alternate pneumococcal conjugate vaccine options; see PCV15 and PCV20 monographs (CDC/ACIP [Kobayashi 2022a]).

Dosage Forms: US

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

Injection, suspension:

Prevnar 13: 2 mcg of each capsular saccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and 4 mcg of serotype 6B [bound to diphtheria CRM197 protein ~34 mcg] per 0.5 mL (0.5 mL) [contains polysorbate 80, and yeast]

Generic Equivalent Available: US

No

Medication Guide and/or Vaccine Information Statement (VIS)

In the US, the appropriate CDC-approved Vaccine Information Statement (VIS) must be provided to the patient prior to administering each dose of this vaccine; VIS is available at hhttps://www.cdc.gov/vaccines/hcp/vis/vis-statements/pcv.pdf.

Administration: Adult

IM: Shake well prior to use. Do not use if a homogenous white suspension does not form. Administer IM in the deltoid muscle. Do not inject IV or SUBQ; avoid intradermal route. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, adolescents and adults 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 (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]).

Administration: Pediatric

IM: Shake vial well before withdrawing the dose; administer IM into midlateral aspect of the thigh in infants and small children; administer in the deltoid area to older children and adults; not for IV or SUBQ administration. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (ACIP [Kroger 2022]). 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 (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 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 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]).

Use: Labeled Indications

Pneumococcal disease prevention:

  • Active immunization of infants ≥6 weeks of age, children, adolescents, and adults for prevention of invasive disease caused by Streptococcus pneumoniae serotypes contained in the vaccine

  • Active immunization of infants ≥6 weeks of age and children <6 years of age for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F

  • Active immunization of adolescents ≥18 years of age and adults for the prevention of pneumonia caused by S. pneumoniae serotypes contained in the vaccine

Advisory Committee on Immunization Practices recommendations:

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination with PCV13 for the following persons (CDC/ACIP [Kobayashi 2015]; CDC/ACIP [Kobayashi 2022a]; CDC/ACIP [Nuorti 2010]):

  • All infants and children 2 to 59 months of age

  • Children 60 to 71 months of age with underlying medical conditions including immunocompetent children 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; children with functional or anatomic asplenia, including sickle cell disease or other hemoglobinopathies, congenital or acquired asplenia, or splenic dysfunction; children with immunocompromising conditions including congenital 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, or other diseases requiring immunosuppressive drugs (including long-term systemic corticosteroids and radiation therapy)

  • Children ≥6 years of age and Adolescents ≤18 years of age (CDC/ACIP 2013): The ACIP also recommends routine vaccination for persons with the following underlying medical conditions: Immunocompetent persons with cerebrospinal fluid leaks or cochlear implants; persons with functional or anatomic asplenia, including sickle cell disease or other hemoglobinopathies, congenital or acquired asplenia; persons with immunocompromising conditions including 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)

Note: Pneumococcal conjugate vaccines that are now recommended in adults include 15- and 20-valent pneumococcal conjugate vaccines (PCV15 and PCV20) (ACIP/CDC [Kobayashi 2022a]).

Medication Safety Issues
Sound-alike/look-alike issues:

Pneumococcal 13-Valent Conjugate Vaccine (Prevnar 13, PCV13) may be confused with Pneumococcal 23-Valent Polysaccharide Vaccine (Pneumovax 23), Pneumococcal 15-Valent Conjugate Vaccine (Vaxneuvance, PCV15), and Pneumococcal 20-Valent Conjugate Vaccine (Prevnar 20, PCV20).

PCV13 (pneumococcal 13-valent conjugate vaccine) may be confused with PPSV23 (pneumococcal 23-valent polysaccharide vaccine), PCV15 (pneumococcal 15-valent conjugate vaccine) and PCV20 (pneumococcal 20-valent conjugate vaccine).

Prevnar 13 (pneumococcal 13-valent conjugate vaccine) may be confused with Prevnar 20 (pneumococcal 20-valent conjugate vaccine).

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).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Central nervous system: Chills (adults), drowsiness, fatigue (adults), headache (adults), insomnia, irritability (infants and children)

Dermatologic: Skin rash (adults: >10%; children and infants: >1%; including urticaria-like rash)

Gastrointestinal: Decreased appetite

Local: Erythema at injection site, pain at injection site (adults), swelling at injection site, tenderness at injection site

Neuromuscular & skeletal: Arthralgia (adults), decreased range of motion (arm), myalgia (adults)

Miscellaneous: Fever

1% to 10%:

Dermatologic: Urticaria

Gastrointestinal: Diarrhea, vomiting

<1%, postmarketing, and/or case reports: Anaphylactic shock, anaphylactoid reaction, anaphylaxis, angioedema, apnea, injection site inflammation (dermatitis), injection-site pruritus, crying (abnormal), cyanosis, erythema multiforme, febrile seizures, hypersensitivity reaction (bronchospasm, dyspnea, facial edema), hypotonia, lymphadenopathy (injection site), pallor, seizure, urticaria at injection site

Contraindications

Severe allergic reaction (eg, anaphylaxis) to pneumococcal vaccine, any component of the formulation, or any diphtheria toxoid-containing vaccine

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine use (ACIP [Kroger 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) occurs (ACIP [Kroger 2022]).

• Asplenia: Use of pneumococcal conjugate vaccine does not replace use of the 23-valent pneumococcal polysaccharide vaccine in children ≥24 months of age with asplenia.

• 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]).

• Chronic illness: Use of pneumococcal conjugate vaccine does not replace use of the 23-valent pneumococcal polysaccharide vaccine in children ≥24 months of age with chronic illness (CDC/ACIP [Nuorti 2010]).

• HIV: Use of pneumococcal conjugate vaccine does not replace use of the 23-valent pneumococcal polysaccharide vaccine in children ≥24 months with HIV infection (CDC/ACIP [Nuorti 2010]).

• Pneumococcal infections: Not to be used to treat pneumococcal infections or to provide immunity against diphtheria.

• Sickle cell disease: Use of pneumococcal conjugate vaccine does not replace use of the 23-valent pneumococcal polysaccharide vaccine in children ≥24 months with sickle cell disease (CDC/ACIP [Nuorti 2010]).

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2022]).

• Pneumococcal polysaccharide vaccine (PPSV23): Receipt of PPSV23 within 1 year prior to pneumococcal conjugate vaccine (PCV13) diminishes response to PCV13 when compared to response in PPSV23 naïve individuals.

• 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]).

Dosage form specific issues:

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

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 (ACIP [Kroger 2022]; IDSA [Rubin 2014]). Use of pneumococcal conjugate vaccine does not replace use of the 23-valent pneumococcal polysaccharide vaccine in children ≥24 months who are immunocompromised (CDC/ACIP [Nuorti 2010]). 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]).

• Older adults: Antibody responses were lower in older adults >65 years of age compared to adults 50 to 59 years of age.

• Premature infants: Antibody responses were lower in preterm infants (<37 weeks gestational age) compared to term infants (≥37 weeks gestational age). 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: 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).

• 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]).

Warnings: Additional Pediatric Considerations

Febrile seizures have been reported; CDC reports indicate that young children appear to be at increased risk of febrile seizures when given the pneumococcal conjugate vaccine (PCV13) at the same time as the inactivated influenza virus vaccine (TIV); the risk appears to be greatest from ages 12 to 23 months. Because febrile seizures are typically benign and occur in 2% to 5% of all young children, the ACIP does not recommend a delay in administration of either vaccine or altering the vaccine schedule in any manner due to the potential risk of infection.

Metabolism/Transport Effects

None known.

Drug Interactions

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

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

Influenza Virus Vaccine (Inactivated): Pneumococcal Conjugate Vaccine (13-Valent) may diminish the therapeutic effect of Influenza Virus Vaccine (Inactivated). Influenza Virus Vaccine (Inactivated) may diminish the therapeutic effect of Pneumococcal Conjugate Vaccine (13-Valent). Risk C: Monitor therapy

Meningococcal (Groups A / C / Y and W-135) Conjugate Vaccine: May diminish the therapeutic effect of Pneumococcal Conjugate Vaccine (13-Valent). Management: Administer MenACYW-D (Menactra brand) vaccine at least 4 weeks after the final dose of the PCV13 vaccine series in patients with anatomic asplenia or functional asplenia. For details and recommendations for children under 2 years, see full monograph. Risk D: Consider therapy modification

Methotrexate: May diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

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

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

Pregnancy Considerations

Adverse events 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 are 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).

Breastfeeding Considerations

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 treatment to the mother. Administration does not affect the safety of breastfeeding for the mother or the infant. Maternal administration of non-live vaccines has not been shown to affect the safety of the breastfed infant or mother. Breastfeeding infants should be vaccinated according to the recommended schedules (ACIP [Kroger 2022]).

Monitoring Parameters

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.

Mechanism of Action

Promotes active immunization against invasive disease caused by S. pneumoniae capsular serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, all which are individually conjugated to CRM197 protein

Brand Names: International
  • Prevenar 13 (AE, AR, AT, AU, BB, BE, BH, CH, CL, CO, CR, CY, CZ, DE, DK, DO, EC, EE, ES, ET, FR, GB, GT, HK, HN, HR, ID, IE, IL, IS, JP, KR, LB, LT, LU, LV, MT, MY, NI, NL, NO, NZ, PA, PH, PL, PT, QA, RO, SA, SE, SG, SI, SK, SV, TH, TW, ZW)


For country code abbreviations (show table)
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  7. Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among children aged 6-18 years with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2013;62(25):521-524. [PubMed 23803961]
  8. Centers for Disease Control and Prevention (CDC). Vaccination guidance during a pandemic. Updated October 20, 2020. Available at https://www.cdc.gov/vaccines/pandemic-guidance/index.html
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