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Pneumococcal Conjugate Vaccine (13-Valent)

Pronunciation

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

Index Terms

  • 13-Valent Pneumococcal Vaccine
  • PCV
  • PCV13
  • Pneumococcal 13-Valent Conjugate Vaccine

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 aluminum, polysorbate 80, and yeast]

Brand Names: U.S.

  • Prevnar 13

Pharmacologic Category

  • Vaccine
  • Vaccine, Inactivated (Bacterial)

Pharmacology

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

US labeling:

Pneumococcal disease prevention:

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

Active immunization of infants ≥6 weeks and children less than 6 years 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 and adults for the prevention of pneumonia caused by S. pneumoniae serotypes contained in the vaccine

Canadian labeling:

Immunization of infants ≥6 weeks, children, and adolescents through 17 years against invasive disease caused by Streptococcus pneumoniae serotypes included in the vaccine

Immunization of adults ≥18 years against pneumococcal pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes included in the vaccine

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

All infants and children age 2 to 59 months

Children 60 to 71 months 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, compliment 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 who received ≥1 dose of PCV7

Note: Routine use is not recommended for healthy children ≥5 years.

Children ≥6 years and Adolescents ≤18 years (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, compliment 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)

All adults ≥65 years (CDC/ACIP [Tomczyk 2014])

Contraindications

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

Dosing: Adult

Immunization:

US labeling: IM: 0.5 mL as a single dose.

Canadian labeling: Adults ≥18 years (including those at high risk of infection [eg, sickle cell disease, HIV infection] or previously vaccinated with a pneumococcal polysaccharide vaccine): IM: 0.5 mL as a single dose (PCV13 should be administered prior to pneumococcal polysaccharide vaccine if sequential administration is considered).

Alternative recommendations:

Adults 19 to <65 years with specified underlying medical conditions: IM: 0.5 mL as a single dose

Note: Which vaccines are indicated (pneumococcal conjugate vaccine [PCV 13] 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 [Kim 2016]; 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 PCV 13 doses are needed

Revaccination: Administration of additional doses is not recommended for adults (ACIP [Kim 2016]).

Adults ≥65 years: IM: 0.5 mL as a single dose

Note: All patients should receive both pneumococcal conjugate vaccine (PCV13) and pneumococcal polysaccharide vaccine (PPSV23) (ACIP [Kobayashi 2015]; CDC/ACIP [Tomczyk 2014]):

Pneumococcal vaccine-naive or vaccination status unknown: Administer PCV13 followed by PPSV23 ≥1 year later (minimum interval of 8 weeks for certain high-risk groups)

Previously received PPSV23 (at age ≥65 years) but not PCV13: Administer PCV13 ≥1 year after the last dose of PPSV23

Previously received PPSV23 (at age <65 years) but not PCV13: Administer PCV13 ≥1 year after the last dose of PPSV23; administer PPSV23 ≥1 year later (minimum interval of 8 weeks for certain high-risk groups) and at least 5 years after the last PPSV23 dose

Previously received PCV13: No additional PCV13 doses are needed

HSCT, autologous or allogeneic (Canadian labeling): IM: 0.5 mL for a total of 4 doses with first dose administered 3 to 6 months after HSCT followed by second and third doses administered at least 1 month apart and then a booster dose 6 months after the third dose.

Dosing: Geriatric

Immunization:

Adults ≥65 years: All patients should receive both pneumococcal conjugate vaccine (PCV 13) and pneumococcal polysaccharide vaccine (PPSV23) (ACIP [Kobayashi 2015]; CDC/ACIP [Tomczyk 2014]):

Pneumococcal vaccine-naïve: IM: Administer PCV13 0.5 ml as a single dose, followed by PPSV23 ≥1 year later (minimum interval of 8 weeks for certain high-risk groups)

Previously received pneumococcal polysaccharide vaccine (PPSV23):

Received at age <65 years: IM: Administer PCV13 0.5 mL as a single dose ≥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 at age ≥65 years: IM: Administer PCV13 0.5 mL as a single dose ≥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

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

Alternative recommendations [Canadian National Advisory Committee on Immunizations (NACI) 2012-2014]: Healthy infants: May consider a total of three 0.5 mL doses with the first dose administered at 2 months, the second dose at 4 months of age and a third dose at 12 months.

Catch-up Immunization (previously unvaccinated with PCV13): Infants ≥ 7 months, Children, and Adolescents:

Infants 7 to 11 months: 0.5 mL for a total of 3 doses; first 2 doses at least 4 weeks apart, followed by a third dose after the 1-year birthday (12 to 15 months), separated from the second dose by at least 8 weeks

Children 12 to 23 months: 0.5 mL for a total of 2 doses, separated by at least 8 weeks

Healthy Children 24 to 59 months: 0.5 mL as a single dose

Children 24 to 71 months with an underlying medical condition: 0.5 mL for a total of 2 doses, separated by 8 weeks (CDC/ACIP [Nuorti 2010])

Children 6 through 17 years: 0.5 mL as a single dose. If PCV7 was previously administered, give PCV13 ≥8 weeks after that dose

Canadian labeling: Children >1 year (previous completed vaccination with PCV7): IM: 0.5 mL as a single dose in the second year of life

HSCT, autologous or allogeneic (Canadian labeling): Children ≥2 years and Adolescents: Refer to adult dosing.

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

Shake well prior to use. Do not use if a homogenous white suspension does not form. Administer IM (deltoid muscle for toddlers, young children, and adults or lateral midthigh in infants). 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]). To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (NCIRD/ACIP 2011). 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 (NCIRD/ACIP 2011).

Storage

Store under refrigeration at 2°C to 8°C (36°F to 46°F); do not freeze; discard if frozen. Note: The Canadian labeling suggests that the vaccine is stable at temperatures up to 25°C (77°F) for 4 days.

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

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). Monitor therapy

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% (Limited to important or life-threatening): Anaphylactoid reaction, apnea, crying (abnormal), cyanosis, erythema multiforme, febrile seizures, hypersensitivity reaction (bronchospasm, dyspnea, facial edema), hypotonia, injection site inflammation (dermatitis), injection site pruritus, lymphadenopathy (injection site), pallor, seizure

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).

• Fever: The use of a previous pneumococcal conjugate vaccine (PCV7) administered concomitantly with Infanrix hexa (DTaP-HepB-IPV-Hib) [Canadian product] in infants was associated with higher rates of fever; increased rates of convulsions (with or without fever), and hypotonic-hyporesponsive episodes (HHE) have been observed with concomitant use of PCV13 and Infanrix hexa. 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).

• 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 (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) occurs (NCIRD/ACIP 2011).

• 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) and patients on anticoagulant therapy; 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 (NCIRD/ACIP 2011).

• 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:

• 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 (NCIRD/ACIP 2011).

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: 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). 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 (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:

• 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 ACIP Recommended Immunization Schedule (ACIP [Kim 2016]). 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 (NCIRD/ACIP 2011).

Monitoring Parameters

Monitor for syncope for 15 minutes following administration (NCIRD/ACIP 2011). 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 shown adverse fetal effects. Inactivated vaccines have not been shown to cause increased risks to the fetus (NCIRD/ACIP 2011).

Patient Education

• Discuss specific use of vaccine and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience 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), or insomnia (children) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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