Pneumococcal Conjugate Vaccine (13-Valent)

Dosage Forms

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]

Pharmacology

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

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 for the following (ACIP [Kobayashi 2015]; 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, 62[25] 2013), and Adults ≥19 years (CDC/ACIP, 61[40] 2012): 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)

• Adults ≥65 years of age (CDC/ACIP [Matanock 2019]): Routine vaccination for all individuals is not recommended. For persons who are immunocompetent, do not have a cerebrospinal fluid leak or cochlear implant, and who have not previously received pneumococcal conjugate vaccine, 13-valent (PCV13), ACIP recommends shared clinical decision-making to determine if PCV13 vaccination is appropriate for a particular person; consideration should be given to potential increased risk for exposure to PCV13 serotypes and risk for developing pneumococcal disease as a result of underlying conditions. Those at potentially increased risk for exposure to PCV13 serotypes include: Nursing home or long-term care residents; those residing in setting with low pediatric PCV13 uptake; and those traveling to setting with no pediatric PCV13 immunization program.

Contraindications

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

Dosage and Administration

Dosing: Adult

Immunization: IM: 0.5 mL as a single dose.

Immunization recommended for the following:

Adults 19 to <65 years of age with specified underlying medical conditions:

Note: Which vaccines are indicated (pneumococcal conjugate vaccine [PCV13] and/or pneumococcal polysaccharide vaccine [PPSV23]) is dependent on previous pneumococcal vaccination history; some medical conditions do not require PCV13 [see guidelines for details] (ACIP [Kobayashi 2015]):

Pneumococcal vaccine-naive or vaccination status unknown: Administer PCV13 followed by PPSV23 at least 8 weeks later

Previously received PPSV23 but not PCV13: Administer PCV13 ≥1 year after the PPSV23 dose

Previously received PCV13 but not PPSV23: No additional PCV13 doses are needed

Revaccination: Administration of additional doses is not recommended for adults.

Hematopoietic stem cell transplantation (HSCT) (off label): IM: 0.5 mL for a total of 3 doses with first dose administered 3 to 6 months after HSCT followed by second and third doses administered at least 1 month apart (ACIP [Kroger 2017])

Dosing: Geriatric

Immunization: IM: 0.5 mL as a single dose.

Adults ≥65 years of age: Note: Routine administration of pneumococcal conjugate vaccine, 13-valent (PCV13) to patients ≥65 years of age is not recommended; administration should be based on shared clinical decision-making for persons who are immunocompetent, do not have a cerebrospinal fluid leak or cochlear implant, and who have not previously received PCV13. All persons ≥65 years of age should receive pneumococcal polysaccharide vaccine (PPSV23) (ACIP [Kobayashi 2015]; CDC/ACIP [Matanock 2019]):

Immunocompromised persons or those with cochlear implant or cerebrospinal fluid leak: 1 dose PCV13 if no previous PCV13 vaccination.

Vaccination based on shared clinical decision-making:

Pneumococcal vaccine-naive: Administer 1 dose PCV13, followed by PPSV23 ≥1 year later (minimum interval of 8 weeks for certain high-risk groups).

Previously received PPSV23 but not PCV13:

Received PPSV23 at age <65 years: Administer 1 dose PCV13 ≥1 year after the last dose of PPSV23, followed by PPSV23 at least ≥1 year later (minimum interval of 8 weeks for certain high-risk groups) and at least 5 years after the last dose of PPSV23.

Received PPSV23 at age ≥65 years: Administer 1 dose PCV13 ≥1 year after the last dose of PPSV23; no additional doses of PPSV23 are needed for routine vaccination.

Previously received PCV13: No additional PCV13 doses are needed.

Dosing: Pediatric

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 2017]).

Primary immunization; all patients: Note: Preterm infants should be vaccinated according to their chronological age from birth.

Infants and Children 6 weeks to 15 months: IM: 0.5 mL per dose for a total of 4 doses given as follows: the first dose may be given as young as 6 weeks of age, but is typically given at 8 weeks (2 months of age); the 3 remaining doses are usually given at 4, 6, and 12 to 15 months of age. The recommended dosing interval is 4 to 8 weeks; dependent upon patient age; the minimum interval between doses in infants <1 year of age is 4 weeks and the minimum interval between the third and fourth dose is 8 weeks

Canadian recommendations: Healthy infants: IM: May consider a total of three 0.5 mL doses with the first dose administered at 2 months of age, the second dose at 4 months of age, and a third dose at 12 months of age (Canadian National Advisory Committee on Immunizations [NACI] 2016).

Catch-up immunization, healthy patients: ACIP recommendations: Infants and Children 4 months to 6 years: Note: Do not restart the series, refer to current immunization guidelines for specific schedule and timing of dose based on patient age and previous number of doses; IM: 0.5 mL per dose for a total of 1 to 4 doses

High-risk conditions; catch-up or revaccination:

Infants ≥4 months and Children <24 months: For catch-up immunization, refer to Catch-up immunization, healthy patients dosing (CDC/ACIP [Nuorti 2010]).

Children 2 through 5 years [CDC/ACIP [Nuorti 2010]):

Pneumococcal vaccine-naïve (no previous PCV13): IM: 0.5 mL for a total of 2 doses at least 8 weeks apart

Previously vaccinated with PCV13:

Previously received <3 doses: IM: 0.5 mL dose for a total of 2 doses at least 8 weeks apart and at least 8 weeks after the most recent dose

Previously received 3 doses: IM: 0.5 mL as a single dose ≥8 weeks after most recent dose

Children and Adolescents 6 to 18 years (CDC/ACIP 62[25] 2013):

Pneumococcal vaccine-naïve (no previous PCV13 or PPSV23 vaccine): IM: 0.5 mL as a single dose

Previously vaccinated with PPSV23 vaccine: If PCV13 has never been administered, give PCV13 vaccine: IM: 0.5 mL as a single dose ≥8 weeks after the last dose of PPSV23 vaccine. The PCV13 vaccine should be administered even if child has previously received PCV7.

Administration

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. Concurrent administration of PCV13 and PPV23 has not been studied and is not recommended (CDC/ACIP [Nuorti 2010]). 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 2017]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.

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 2017).

Storage

Store under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze; discard if frozen. Stable at up to 25°C (77°F) for 4 days.

Drug Interactions

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). 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. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification

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

Meningococcal (Groups A / C / Y and W-135) Diphtheria Conjugate Vaccine: May diminish the therapeutic effect of Pneumococcal Conjugate Vaccine (13-Valent). Management: It is recommended to administer PCV13 at least 4 weeks prior to the administration of MenACYW-D (Menactra brand) vaccine in persons with anatomic asplenia or functional asplenia. This interaction does not apply to the MenACYW-CRM (Menveo brand) vaccine. Consider therapy modification

Pneumococcal Polysaccharide Vaccine (23-Valent): May diminish the therapeutic effect of Pneumococcal Conjugate Vaccine (13-Valent). Management: It is recommended to administer PCV13 prior to administration of PPSV23. The recommended interval between vaccine administrations differs by patient age and comorbidities. See full monograph for details. Consider therapy modification

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Adverse Reactions

>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

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 2017]).
• 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 2017]).

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 2017]).
• 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 2017]).
• 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 2017]).
• 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 2017]).

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 2017]; 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 2017]; IDSA [Rubin 2014]).
• Elderly: Antibody responses were lower in older adults >65 years compared to adults 50 to 59 years.
• 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 2017]). 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 2017]).

Monitoring Parameters

Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2017]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy

Pregnancy Considerations

Animal reproduction studies have not shown adverse fetal effects. Inactivated vaccines have not been shown to cause increased risks to the fetus (ACIP [Kroger 2017]).

Patient Education

What is this drug used for?

• It is used to prevent infections caused by Streptococcus pneumoniae.

Frequently reported side effects of this drug

• Loss of strength and energy
• Headache
• Chills
• Lack of appetite
• Muscle pain
• Joint pain
• Injection site pain or irritation
• Difficulty moving arm that injection was given
• Fever (children)
• Irritability (children)
• Fatigue (children)
• Trouble sleeping (children)
• Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

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