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Pneumococcal conjugate vaccine (20-Valent) (PCV20): Drug information

Pneumococcal conjugate vaccine (20-Valent) (PCV20): Drug information
(For additional information see "Pneumococcal conjugate vaccine (20-Valent) (PCV20): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Prevnar 20
Brand Names: Canada
  • Prevnar 20
Pharmacologic Category
  • Vaccine;
  • Vaccine, Inactivated (Bacterial)
Dosing: Adult
Pneumococcal disease prevention

Pneumococcal disease prevention: IM: 0.5 mL as a single dose.

CDC/ACIP recommendations: Adults 19 to 64 years of age with specified underlying medical conditions (CDC/ACIP [Kobayashi 2022]):

Primary immunization: IM: 0.5 mL as a single dose.

Previously received only PPSV23 but not a pneumococcal conjugate vaccine: May administer a single dose of PCV20 (or PCV15) ≥1 year after last PPSV23 dose.

Previously received PCV13 but not the follow-up PPSV23 dose:If PPSV23 is not available, may administer one dose of PCV20 ≥8 weeks after PCV13 dose.

Previously received PCV13 and PPSV23:Additional vaccination with PCV20 not currently recommended.

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 (CDC/ACIP [Kobayashi 2022]):

Primary immunization: IM: 0.5 mL as a single dose. Note: If a person ≥65 years of age received PCV20 (or another pneumococcal conjugate vaccine) at <65 years of age, no additional pneumococcal conjugate vaccine doses are needed.

Previously received only PPSV23 but not a pneumococcal conjugate vaccine: May administer a single dose of PCV20 (or PCV15) ≥1 year after last PPSV23 dose.

Previously received PCV13 but not the follow-up PPSV23 dose:If PPSV23 is not available, may administer one dose of PCV20 ≥1 year after PCV13. Note: A shorter interval (eg, ≥8 weeks) is appropriate for persons with immunocompromising conditions, cochlear implant, or cerebrospinal fluid leak.

Previously received PCV13 and PPSV23:Additional vaccination with PCV20 not currently recommended.

Dosage Forms: US

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

Suspension Prefilled Syringe, Intramuscular:

Prevnar 20: 0.5 mL (0.5 mL) [contains polysorbate 80]

Generic Equivalent Available: US

No

Dosage Forms: Canada

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

Suspension Prefilled Syringe, Intramuscular:

Prevnar 20: 0.5 mL (0.5 mL) [contains polysorbate 80]

Medication Guide and/or Vaccine Information Statement (VIS)

In the United States, the appropriate CDC-approved Vaccine Information Statement (VIS) should be provided to the patient/caregiver before administering each dose of this vaccine. If purchased under CDC contract, the VIS must be provided and the VIS edition date and date it was provided to the patient/caregiver should be recorded. VIS is available at https://www.cdc.gov/vaccines/hcp/vis/vis-statements/pcv.html.

Administration: Adult

IM: Hold syringe horizontally and shake well prior to use. Do not use if a homogenous white suspension does not form. Administer IM into the deltoid muscle (ACIP [Kroger 2022]). 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 (Cross 2016; Foster 2013). Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, patients should be vaccinated while seated or lying down (ACIP [Kroger 2022]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, Vaccine Information Statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (≤23-gauge) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (ACIP [Kroger 2022]).

Use: Labeled Indications

Pneumococcal disease prevention: Active immunization of persons ≥18 years of age for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B,18C, 19A, 19F, 22F, 23F, and 33F.

Advisory Committee on Immunization Practices recommendations:

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination in the following persons (CDC/ACIP [Kobayashi 2022]):

  • Adults 19 to 64 years of age with any of the following underlying medical conditions or risk factors: alcoholism, chronic heart disease (including heart failure, cardiomyopathies), chronic liver disease, chronic lung disease (including chronic obstructive pulmonary disease, emphysema, asthma), cigarette smoking, diabetes mellitus, cochlear implant, cerebrospinal fluid leaks, asplenia (congenital or acquired), sickle cell disease or other hemoglobinopathies, immunocompromising conditions (eg, chronic renal failure, congenital or acquired immunodeficiency [including B- or T-cell deficiency, complement deficiencies and phagocytic disorders; excluding chronic granulomatous disease], malignancy, HIV infection, Hodgkin disease, iatrogenic immunosuppression [including long-term systemic corticosteroid treatment, radiation therapy], leukemia, lymphoma, multiple myeloma, nephrotic syndrome, solid organ transplant)

  • Adults ≥65 years of age

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

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

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

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

PCV (pneumococcal conjugate vaccine) may be confused with MCV (meningococcal ACYW conjugate vaccine, MCV4 is the correct abbreviation).

Adverse Reactions

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

>10%:

Local: Injection-site reaction (53% to 81%, including erythema at injection site [5% to 9%], pain at injection site [50% to 81%], swelling at injection site [4% to 12%])

Nervous system: Fatigue (29% to 43%), headache (14% to 39%)

Neuromuscular & skeletal: Arthralgia (7% to 17%), myalgia (32% to 67%)

1% to 10%: Miscellaneous: Fever (≤2%)

Contraindications

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

Warnings/Precautions

Concerns related to adverse effects:

• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis, tendinitis) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2022]).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2022]).

• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2022]).

Concurrent drug therapy issues:

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

• Vaccines: In order to maximize vaccination rates, the Advisory Committee on Immunization Practices recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist (ACIP [Kroger 2022]).

Special populations:

• Altered immunocompetence: Consider deferring immunization during periods of severe immunosuppression (eg, patients receiving chemo-/radiation therapy or other immunosuppressive therapy including high-dose corticosteroids); may have a reduced response to vaccination. In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines (ACIP [Kroger 2022]; IDSA [Rubin 2014]). Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2022]; IDSA [Rubin 2014]).

• Older adult: Antibody responses were lower in adults ≥70 years of age compared to adults 18 to 64 years of age.

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). See manufacturer's labeling.

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2022]). One study reported that routine prophylactic administration of acetaminophen prior to vaccination to prevent fever decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula 2009).

• Appropriate use: Specific recommendations for use of vaccines 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 Infectious Diseases Society of America (Rubin 2014).

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (ACIP [Kroger 2022]).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetaminophen: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

Cladribine: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of cladribine when possible. Patients vaccinated less than 14 days before initiating or during cladribine should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

Corticosteroids (Systemic): May diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid combination

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Risk D: Consider therapy modification

Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Immunosuppressants (Miscellaneous Oncologic Agents): May diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Immunosuppressants (Therapeutic Immunosuppressant Agents): May diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

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 (20-Valent). Risk C: Monitor therapy

Propacetamol: May diminish the therapeutic effect of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modification

RiTUXimab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of rituximab when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 6 months after therapy is complete. Risk D: Consider therapy modification

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

Teplizumab: May diminish the therapeutic effect of Pneumococcal Vaccines. Management: Vaccination with inactivated vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during therapy, or for 6 weeks after completion of therapy. See full mono for recommendations for number, order, and timing of vaccines. Risk D: Consider therapy modification

Teplizumab: May diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Vaccination with inactivated or non-replicating vaccines is not recommended in the 2 weeks prior to teplizumab therapy, during treatment, or for 6 weeks following completion of therapy. Risk D: Consider therapy modification

Pregnancy Considerations

Adverse fetal effects were not observed in animal developmental toxicity studies.

Maternal administration of non-live bacterial vaccines has not been shown to cause increased risks to the fetus (ACIP [Kroger 2022]). Although specific recommendations for vaccination of pregnant patients is not available (CDC/ACIP [Kobayashi 2022]), 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 during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother. Maternal administration of non-live vaccines has not been shown to affect the safety of the breastfed infant or mother (ACIP [Kroger 2022]).

Monitoring Parameters

Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Kroger 2022]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Mechanism of Action

Promotes active immunization against pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B,18C, 19A, 19F, 22F, 23F, and 33F, all which are individually conjugated to CRM197 protein.

Pharmacokinetics

Onset: Immune response was elicited by 1 month postvaccination.

Pricing: US

Suspension Prefilled Syringe (Prevnar 20 Intramuscular)

0.5 mL (per 0.5 mL): $298.65

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

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  2. American College of Obstetricians and Gynecologists (ACOG). Maternal Immunization Practice Advisory October 2022. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2022/10/maternal-immunization. Accessed December 13, 2022.
  3. 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]
  4. 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]
  5. Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313. doi:10.1034/j.1600-0536.2002.4705104.x [PubMed 12534540]
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  7. Kroger A, Bahta L, Hunter 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/downloads/general-recs.pdf. Accessed February 10, 2022.
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  12. Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313. doi:10.1016/s0140-6736(95)90963-x [PubMed 7746084]
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