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

Pneumococcal conjugate vaccine (13-valent) (PCV13): Drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
Brand Names: US
  • Prevnar 13 [DSC]
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 (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).

Canadian recommendations: The Canadian National Advisory Committee on Immunization (NACI) provides different recommendations as compared to the CDC; see NACI recommendations for details.

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: 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 (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).

Dosing: Pediatric

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

Dosage Guidance:

Dosing: 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 (Ref).

Primary immunization

Primary immunization:

Note: Although pneumococcal conjugate vaccine 13-valent (PCV13) is FDA approved, ACIP recommends use of pneumococcal conjugate vaccine 15-valent (PCV15) or pneumococcal conjugate vaccine 20-valent (PCV20). If only PCV13 is available when a patient is due for a pneumococcal conjugate vaccine, PCV13 may be used (Ref).

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 (Ref).

Catch-up immunization

Catch-up immunization:

Note: Although pneumococcal conjugate vaccine 13-valent (PCV13) is FDA approved, ACIP recommends use of pneumococcal conjugate vaccine 15-valent (PCV15) or pneumococcal conjugate vaccine 20-valent (PCV20). If only PCV13 is available when a patient is due for a pneumococcal conjugate vaccine, PCV13 may be used (Ref).

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 (Ref).

Children <2 years: IM: 0.5 mL per dose for 2 doses administered ≥8 weeks apart (Ref).

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 (Ref).

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 pneumococcal polysaccharide vaccine 23-valent (PPSV23) was previously administered, initiate pneumococcal conjugate vaccination ≥8 weeks after PPSV23 dose (Ref).

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 (Ref).

Patients who previously received an incomplete series with another pneumococcal conjugate vaccine (eg, PCV13):

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 (Ref).

Children 2 to <6 years (Ref):

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.

Adverse Reactions

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

>10%:

Dermatologic: Skin rash (3% to 21%)

Gastrointestinal: Decreased appetite (5% to 56%), vomiting (≤15%)

Local: Erythema at injection site (5% to 31%), pain at injection site (36% to 97%), swelling at injection site (7% to 39%)

Nervous system: Chills (8% to 38%), fatigue (19% to 81%), headache (16% to 81%)

Neuromuscular & skeletal: Arthralgia (7% to 42%; aggravated arthralgia: 5% to 29%), decreased range of motion (arm: 11% to 75%), myalgia (18% to 82%; aggravated myalgia: 9% to 56%)

1% to 10%: Miscellaneous: Fever (≤7%)

<1%: Dermatologic: Erythema multiforme

Postmarketing (any population):

Dermatologic: Pallor

Hematologic & oncologic: Immune thrombocytopenia (Gupta 2016)

Hypersensitivity: Anaphylactic shock, anaphylaxis, angioedema, nonimmune anaphylaxis

Local: Injection-site reaction (including dermatitis, injection-site pruritus, lymphadenopathy, and urticaria at injection site)

Nervous system: Hypertonia

Respiratory: Apnea, cyanosis

Miscellaneous: Polyserositis (pleura and pericardium) (Tawfik 2017)

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 2023]).

• 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 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) occurs (ACIP [Kroger 2023]).

• 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 2023]).

• 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 2023]).

• 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 nonlive) for which a person is eligible at a single visit, unless contraindications exist (ACIP [Kroger 2023]).

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: Postpone vaccination during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy [including high-dose corticosteroids]) if appropriate; 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 2023]; 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]). 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 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 2023]). 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 (ACIP [Kroger 2023]).

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.

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] [DSC]

Generic Equivalent Available: US

No

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. 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 (Ref). 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 (Ref). 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 (Ref).

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. If injecting in the deltoid muscle, use proper injection technique (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection (Ref). To prevent syncope-related injuries, adolescents should be vaccinated while seated or lying down (Ref). 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 (Ref).

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.

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 pneumococcal vaccination for the following persons (CDC/ACIP [Kobayashi 2015]; CDC/ACIP [Kobayashi 2023]; 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) (CDC/ACIP [Kobayashi 2023]).

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).

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 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

Anti-CD20 B-Cell Depleting Therapies: May diminish the therapeutic effect 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 enhance the adverse/toxic effect of Vaccines. Atidarsagene Autotemcel may diminish the therapeutic effect of Vaccines. Risk X: Avoid combination

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

Dinutuximab Beta: May diminish the therapeutic effect of Vaccines (Non-Live/Inactivated/Non-Replicating). Risk X: Avoid combination

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 (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 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

Siponimod: May diminish the therapeutic effect 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 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 (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

Pregnancy Considerations

Antibodies generated following PCV vaccination of pregnant patients can be detected in cord blood (CDC/ACIP [Kobayashi 2023]; Weinberg 2021).

Nonlive bacterial vaccines have not been shown to cause increased risks to the fetus (ACIP [Kroger 2023]).

Although specific recommendations for vaccination of pregnant patients are not available (CDC/ACIP [Kobayashi 2023]), 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. Nonlive vaccines have 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 2023]).

Monitoring Parameters

Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]). 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
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Prevenar 13;
  • (AT) Austria: Prevenar 13;
  • (AU) Australia: Prevenar 13 multidose;
  • (BE) Belgium: Prevenar 13;
  • (BG) Bulgaria: Prevenar 13;
  • (BO) Bolivia, Plurinational State of: Prevenar 13;
  • (BR) Brazil: Prevenar 13;
  • (CH) Switzerland: Prevenar 13;
  • (CI) Côte d'Ivoire: Prevenar 13;
  • (CL) Chile: Prevenar 13;
  • (CO) Colombia: Prevenar 13;
  • (CZ) Czech Republic: Prevenar 13;
  • (DE) Germany: Prevenar 13;
  • (DO) Dominican Republic: Prevenar 13;
  • (EC) Ecuador: Prevenar 13;
  • (EE) Estonia: Prevenar 13;
  • (FR) France: Prevenar 13;
  • (GB) United Kingdom: Prevenar 13;
  • (HK) Hong Kong: Prevenar 13;
  • (HR) Croatia: Prevenar 13;
  • (HU) Hungary: Prevenar 13;
  • (IN) India: Prevenar 13;
  • (IT) Italy: Prevenar 13;
  • (KR) Korea, Republic of: Prevenar 13;
  • (KW) Kuwait: Prevenar 13;
  • (MA) Morocco: Prevenar 13;
  • (MX) Mexico: Prevenar 13;
  • (NL) Netherlands: Prevenar 13;
  • (NO) Norway: Prevenar 13;
  • (PA) Panama: Prevenar 13;
  • (PE) Peru: Prevenar 13;
  • (PK) Pakistan: Prevenar 13;
  • (PL) Poland: Prevenar 13;
  • (PR) Puerto Rico: Prevnar 13;
  • (PY) Paraguay: Prevenar 13;
  • (QA) Qatar: Prevenar 13;
  • (RU) Russian Federation: Prevenar 13;
  • (SG) Singapore: Prevenar 13;
  • (SK) Slovakia: Prevenar 13;
  • (SV) El Salvador: Prevenar 13;
  • (TH) Thailand: Prevnar 13;
  • (TR) Turkey: Prevenar 13;
  • (UA) Ukraine: Prevenar 13;
  • (VE) Venezuela, Bolivarian Republic of: Prevenar 13
  1. Alade SL, Brown RE, Paquet A Jr. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]
  2. American Academy of Pediatrics Committee on Infectious Diseases, "Recommendations for the Prevention of Streptococcus pneumoniae Infections in Infants and Children: Use of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) and Pneumococcal Polysaccharide Vaccine (PPSV23)," Pediatrics, 2010, 126(1):186-90. [PubMed 20498180]
  3. American College of Obstetricians and Gynecologists (ACOG). ACOG Committee Opinion No. 741: Maternal Immunization. Obstet Gynecol. 2018;131(6):e214-e217. doi:10.1097/AOG.0000000000002662 [PubMed 29794683]
  4. American College of Obstetricians and Gynecologists (ACOG). Maternal Immunization Practice Advisory. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2022/10/maternal-immunization. Updated October 2022. Accessed December 13, 2022.
  5. Bennett NM. 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. MMWR Morb Mortal Wkly Rep. 2013;62(25):521-528.
  6. Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm. [PubMed 6423951]
  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. Cross GB, Moghaddas J, Buttery J, Ayoub S, Korman TM. Don't aim too high: avoiding shoulder injury related to vaccine administration. Aust Fam Physician. 2016;45(5):303‐306. [PubMed 27166466]
  9. Farrar JL, Gierke R, Andrejko, et al. ACIP updates: recommendations for use of 20-valent pneumococcal conjugate vaccine in children - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(39):1072. doi:10.15585/mmwr.mm7239a5 [PubMed 37768876]
  10. Foster SL, Davis MV. Vaccine administration: preventing serious shoulder injuries. J Am Pharm Assoc (2003). 2013;53(1):102‐103. doi:10.1331/JAPhA.2013.13503 [PubMed 23636163]
  11. Gupta S, Brennan DC. Pneumococcal 13-valent conjugate vaccine (Prevnar 13)-associated immune thrombocytopenic purpura in a renal transplant recipient: a case report. Transplant Proc. 2016;48(1):262-264. doi:10.1016/j.transproceed.2015.12.004 [PubMed 26915880]
  12. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. [PubMed 12534540]
  13. Kim DK, Riley LE, Harriman KH, Hunter P, Bridges CB. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older - United States, 2017. MMWR Morb Mortal Wkly Rep. 2017;66(5):136-138. [PubMed 28182599]
  14. Kobayashi M, Bennett NM, Gierke R, et al. Intervals between PCV13 and PPSV23 vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2015;64(34):944-947. [PubMed 26334788]
  15. Kobayashi M, Farrar JL, Gierke R, et al. Use of 15-valent pneumococcal conjugate vaccine among U.S. children: updated recommendations of the Advisory Committee on Immunization Practices - United States, 2022. MMWR Morb Mortal Wkly Rep. 2022b;71(37):1174-1181. doi:10.15585/mmwr.mm7137a3 [PubMed 36107786]
  16. Kobayashi M, Pilishvili T, Farrar JL, et al. Pneumococcal vaccine for adults aged ≥19 years: recommendations of the Advisory Committee on Immunization Practices, United States, 2023. MMWR Recomm Rep. 2023;72(3):1-39. doi:10.15585/mmwr.rr7203a1 [PubMed 37669242]
  17. Kroger A, Bahta L, Long S, Sanchez P. General best practice guidelines for immunization: best practices guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html. Accessed June 8, 2023.
  18. Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172. [PubMed 10985636]
  19. Matanock A, Lee G, Gierke R, Kobayashi M, Leidner A, Pilishvili T. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: updated recommendations of the Advisory Committee on Immunization Practices [published correction appears in MMWR Morb Mortal Wkly Rep. 2020;68(5152):1195]. MMWR Morb Mortal Wkly Rep. 2019;68(46):1069-1075. doi: 10.15585/mmwr.mm6846a5. [PubMed 31751323]
  20. National Advisory Committee on Immunizations. Pneumococcal vaccine. Canadian immunization guide, 2012-2014. Available at: http://www.phac-aspc.gc.ca/publicat/cig-gci/p04-pneu-eng.php#ru. Accessed August 31, 2015.
  21. National Advisory Committee on Immunization (NACI). Update on the use of 13-valent pneumococcal conjugate vaccine (PNEU-C-13) in addition to 23-valent pneumococcal polysaccharide vaccine (PNEU-P-23) in immunocompetent adults 65 years of age and older – Interim Recommendation. Available at: https://www.canada.ca/en/public-health/services/publications/healthy-living/update-use-of-13-valent-pneumococcal-conjugate-vaccine-pneu-c-13-in-addition-to-23-valent-pneumococcal-polysaccharide-vaccine-pneu-p-23-immunocompetent-adults-65-years-and-older-interim-recommendation.html. Published October 17, 2016. Accessed January 17, 2019.
  22. National Center for Immunization and Respiratory Diseases (NCIRD). General recommendations on immunization—recommendations of the Advisory Committee on Immunization Practices (ACIP) [published correction appears in MMWR Recomm Rep. 2011;60:993]. MMWR Recomm Rep. 2011;60(2):1-64. 4GODalways [PubMed 21293327]
  23. Nuorti JP, Whitney CG; Centers for Disease Control and Prevention (CDC). Prevention of pneumococcal disease among infants and children: use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2010;59(RR-11):1-18. [PubMed 21150868]
  24. Prevnar 13 (pneumococcal conjugate vaccine [13-valent]) [prescribing information]. Philadelphia, PA: Wyeth Pharmaceuticals; July 2019.
  25. Prevnar 13 (pneumococcal conjugate vaccine [13-valent]) [product monograph]. Kirkland, Quebec, Canada: Pfizer Canada ULC, Licensee; August 2019.
  26. Prymula R, Siegrist CA, Chlibek R, et al. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet. 2009;374(9698):1339-1350. [PubMed 19837254]
  27. Reefhuis J, Honein MA, Whitney CG, et al, “Risk of Bacterial Meningitis in Children With Cochlear Implants,” N Engl J Med, 2003, 349:435-45. [PubMed 12890842]
  28. Refer to manufacturer's labeling.
  29. Rubin LG, Levin MJ, Ljungman P, et al. 2013 IDSA clinical practice guideline for vaccination of the immunocompromised host. Clin Infect Dis. 2014;58(3):e44-e100. [PubMed 24311479]
  30. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. [PubMed 7746084]
  31. Tawfik P, Gertner E, McEvoy CE. Severe polyserositis induced by the 13-valent pneumococcal conjugate vaccine: a case report. J Med Case Rep. 2017;11(1):142. doi:10.1186/s13256-017-1305-4 [PubMed 28526059]
  32. Weinberg A, Muresan P, Laimon L, et al; NICHD P1091 study team. Safety, immunogenicity, and transplacental antibody transport of conjugated and polysaccharide pneumococcal vaccines administered to pregnant women with HIV: a multicentre randomised controlled trial. Lancet HIV. 2021;8(7):e408-e419. doi:10.1016/S2352-3018(20)30339-8 [PubMed 33915104]
  33. World Health Organization (WHO). Guiding principles for immunization activities during the COVID-19 pandemic: interim guidance, 26 March 2020. Published March 26, 2020. Available at https://apps.who.int/iris/handle/10665/331590
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