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Pneumococcal Conjugate Vaccine (10-Valent)

Pronunciation

(noo moe KOK al KON ju gate vak SEEN, ten vay lent)

Index Terms

  • 10-Valent Pneumococcal Nontypeable Haemophilus influenzae Protein D Conjugate Vaccine
  • 10-Valent Pneumococcal Vaccine
  • PCV
  • PCV10
  • PHiD-CV
  • Pneumococcal 10-Valent Conjugate Vaccine
  • Pneumococcal Conjugate Vaccine (Nontypeable Haemophilus influenzae [NTHi] Protein D, Diphtheria or Tetanus Toxoid Conjugates) Adsorbed

Pharmacologic Category

  • Vaccine
  • Vaccine, Inactivated (Bacterial)

Pharmacology

Promotes active immunization against invasive disease caused by S. pneumoniae capsular serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F, all which are individually conjugated to a carrier protein (protein D, tetanus toxoid, or diphtheria toxoid); the aluminum salt, a mineral adjuvant, enhances the antibody response.

Use: Labeled Indications

Note: Not approved in the US

Pneumococcal disease prevention: Immunization of infants ≥ 6 weeks and children through 5 years against Streptococcus pneumoniae invasive diseases, pneumonia, and acute otitis media caused by serotypes included in the vaccine

Contraindications

Hypersensitivity to any component of the vaccine

Dosing: Pediatric

Primary immunization: IM: Infants 6 weeks to 6 months:

Three-dose primary series: 0.5 mL/dose for 3 doses, followed by a booster dose of 0.5 mL (for a total of 4 doses). The first dose may be given as young as 6 weeks of age, but is typically given at 2 months of age. The second and third doses should be administered at 4 and 6 months of age. The booster dose should be administered at 12 to 15 months; allow a minimum interval of 1 month between each of the first 3 doses, and 6 months between dose 3 and the booster dose.

Alternatively, infants 2 to 6 months may receive a two-dose primary series: 0.5 mL/dose for 2 doses, followed by a booster dose of 0.5 mL (for a total of 3 doses). The first dose may be given as young as 6 weeks of age, but is typically given at 2 months of age. The second dose should be administered at 4 months of age. The booster dose should be administered at 11 to 12 months; allow a minimum interval of 2 months between doses 1 and 2, and 6 months between doses 2 and the booster dose. Note: May not provide optimal protection particularly in infants at high risk for pneumococcal disease (eg, asplenia, sickle-cell disease, immunosuppressed).

Previously unvaccinated Older Infants and Children: IM:

Children 7 to 11 months: 0.5 mL/dose for a total of 3 doses; 2 doses administered at least 1 month apart, followed by a third dose administered after 1 year of age, separated from the second dose by at least 2 months

Children 12 to 23 months: 0.5 mL/dose for a total of 2 doses, administered at least 2 months apart (manufacturer labeling suggests that a booster dose may be necessary for optimal protection). Note: Two-dose regimen in children 12 to 23 months of age at high risk for pneumococcal disease (eg, asplenia, sickle-cell disease, immunosuppressed) may not provide optimal protection.

Children ≥24 months to <6 years: 0.5 mL/dose for a total of 2 doses, administered at least 2 months apart

Dosing: Renal Impairment

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

Dosing: Hepatic Impairment

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

Administration

Intramuscular (IM): Shake well before use. Administer by IM injection only, preferably into the anterolateral aspect of the thigh in infants and into the deltoid in children. Do not administer intravenously or intradermally. Subcutaneous administration has not been studied.

Rule out bleeding disorders in patients <2 years of age prior to immunization. NACI recommends that patients with bleeding disorders receive all routine recommended vaccinations according to schedule. Bleeding disorders should be corrected prior to immunization (when possible) or immunization should be scheduled shortly after antihemophilia or other similar therapy. In patients with bleeding disorder that cannot be corrected, IM gluteal injections should be avoided (if possible). When immunizing patients with bleeding disorders, a fine-gauge needle of the appropriate length can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 5 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy (eg, aspirin, warfarin, heparin) may be immunized via intramuscular injection without discontinuation of their anticoagulant therapy (NACI 2015).

Storage

Store at 2°C to 8°C (36°F to 46°F) and in original packaging to protect from light. Do not freeze; discard the vaccine if frozen. Vaccine should be administered upon removal from refrigeration; however, the manufacturer labeling states the vaccine may be administered if left outside of refrigeration for ≤3 days at 8°C to 25°C (46°F to 77°F). If multidose vial is not used immediately after opening, store at 2°C to 8°C (36°F to 46°F); discard if not used within 6 hours.

Drug Interactions

Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification

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

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

Adverse Reactions

*Incidence not specifically defined, but reported in the range of 1% to 10%.

>10%:

Central nervous system: Irritability (51% to 66%), drowsiness (33% to 58%)

Gastrointestinal: Anorexia (17% to 31%)

Local: Pain at injection site (23% to 57%), erythema at injection site (38% to 53%), swelling at injection site (28% to 37%)

Miscellaneous: Fever (rectal; ≥38°C ages <2 years: 26% to 37%; >39°C ages <2 years: 2% to 3%; >39°C ages 2 to 5 years: <1%; >40°C ages <2 years: <1%; ≥38°C ages 2 to 5 years*)

1% to 10%:

Local: Induration at injection site

<1% (Limited to important or life-threatening): Apnea (in premature infants ≤28 weeks gestation), bleeding at injection site, crying (abnormal), diarrhea, hematoma at injection site, hypersensitivity reaction (allergic dermatitis, atopic dermatitis, eczema), injection site nodule, seizure (febrile and nonfebrile), skin rash, urticaria, vomiting

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 (NCIRD/ACIP 2011).

• 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 but may occur in children and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (NCIRD/ACIP 2011).

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. Consider deferring 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) (NCIRD/ACIP 2011).

• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia) and patients on anticoagulant therapy; bleeding/hematoma may occur from intramuscular (IM) administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (NCIRD/ACIP 2011).

• Pneumococcal infections: Not to be used to treat pneumococcal infections. Safety and efficacy in children at increased risk for pneumococcal infection (eg, sickle cell disease, splenic dysfunction, HIV infection, malignancy, nephrotic syndrome) has not been established.

Concurrent drug therapy issues:

• Vaccines: In order to maximize vaccination rates, the Canadian National Advisory Committee on Immunization (NACI) 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.

Special populations:

• Altered immunocompetence: Use with caution in severely immunocompromised patients (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 (IDSA [Rubin, 2014]; NCIRD/ACIP, 2011); inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (IDSA [Rubin 2014]).

• Pediatric: Apnea has occurred following IM vaccine administration in some premature infants; consider clinical status implications. Infants born ≤28 weeks' gestation, particularly those with a prior history of respiratory immaturity, may require respiratory function monitoring for 2 to 3 days after administration. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (NCIRD/ACIP 2011).

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and 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 (NCIRD/ACIP 2011).

• Routine immunization: Antibody response is provided only against pneumococcal serotypes included in the vaccine. Antibody response may also be observed to diphtheria toxoid, tetanus toxoid, and protein D (derived from nontypeable Haemophilus influenzae); however, recommended routine administration schedules for diphtheria, tetanus, or H. influenzae type b vaccines should still be followed.

Monitoring Parameters

Consider respiratory monitoring for 48-72 hours in premature infants (born ≤28 weeks gestation) due to risk of apnea. Monitor for syncope for 15 minutes following administration. If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Considerations

Animal reproduction studies have not been conducted. Inactivated vaccines have not been shown to cause increased risks to the fetus (NCIRD/ACIP 2011). This product is indicated for use in infants and children.

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