pneumococcal vaccine 15-valent (Rx)

Brand and Other Names:Vaxneuvance
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, suspension

  • 0.5mL prefilled syringe
  • Conjugated to carrier protein (diphtheria CRM197 protein)

Streptococcus pneumoniae Immunization

Indicated for active immunization for prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae

0.5 mL IM once

ACIP pneumococcal vaccine recommendations

  • Pneumococcal vaccine-naïve or vaccination status unknown
    • ≥65 years: 0.5 mL IM once; follow with dose of 23-valent PPSV ≥1 yr later
    • 19-64 years with certain underlying medical conditions: 0.5 mL IM once (follow with PPSV23 >1 yr later); then, repeat regimen when aged ≥65 years
  • PPSV23 previously received: May receive PCV15 ≥1 years after their last PPSV23 dose at discretion of physician
  • PCV13 previously received: Public health benefits of providing PCV15 to adults who have received PCV13 only or both PCV13 and PPSV23 have not been evaluated; these adults should complete the previously recommended PPSV23 series
  • For more information, see full ACIP recommendations at MMWR January 28, 2022

Dosage Modifications

Renal or hepatic impairment

  • Studies not conducted

Dosing Considerations

Vaccine serotypes include 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F

Contains all serotypes in Prevnar 13 plus 2 additional serotypes (22F and 33F)

Specific medical conditions for aged 19-64 years

  • Alcoholism
  • Chronic heart, liver, or lung disease
  • Cigarette smoking
  • Diabetes mellitus
  • Cochlear implant
  • CSF leak
  • Congenital or acquired asplenia
  • Sickle cell disease or other hemoglobinopathies
  • Chronic renal failure
  • Congenital or acquired immunodeficiencies
  • Generalized malignancy
  • HIV infection
  • Hodgkin disease, leukemia, lymphoma, multiple myeloma
  • Iatrogenic immunosuppression
  • Nephrotic syndrome
  • Solid organ transplant

Dosage Forms & Strengths

injection, suspension

  • 0.5mL prefilled syringe
  • Conjugated to carrier protein (diphtheria CRM197 protein)

Streptococcus pneumoniae Immunization

Indicated for active immunization for prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae in children aged ≥6 weeks

4-dose series: 0.5 mL IM at 2, 4, 6, and 12-15 months of age

First dose may be given as early as 6 weeks old

4-dose series initiated with lower valency pneumococcal conjugate vaccine can be completed with pneumococcal vaccine 15-valent

Catch-up schedule for children who have never received a pneumococcal vaccine

  • Aged at first dose
    • 7-11 months: 3 doses; first 2 doses given at least 4 weeks apart; third dose given after one-year birthday, separated from the second dose by at least 2 months
    • 12-23 months: 2 doses give at least 2 months apart
    • 2-17 years: 1 dose

Catch-up schedule for children previously vaccinated with a pneumococcal vaccine

  • Administer single dose to children and adolescents aged 2-17 years who have received an incomplete series of another pneumococcal vaccine
  • At least 2 months should elapse between receipt of the last dose of another pneumococcal conjugate vaccine and administration of pneumococcal vaccine 15-valent

Dosage Modifications

Renal or hepatic impairment

Studies not conducted

Dosing Considerations

Vaccine serotypes include 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F

Contains all serotypes in Prevnar 13 plus 2 additional serotypes (22F and 33F)

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Interactions

Interaction Checker

and pneumococcal vaccine 15-valent

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (2)

                • tralokinumab

                  tralokinumab will decrease the level or effect of pneumococcal vaccine 15-valent by immunosuppressive effects; risk of infection. Use Caution/Monitor. Limited data are available regarding coadministration with non-live vaccines.

                • voclosporin

                  voclosporin decreases effects of pneumococcal vaccine 15-valent by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment.

                Minor (0)

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                  Adverse Effects

                  >10%

                  Adults

                  • All grades
                    • Pain (55.1-75.8%)
                    • Fatigue (18.1-34.3%)
                    • Myalgia (15.7-28.8%)
                    • Headache (13.4-26.5%)
                    • Swelling (14.2-21.7%)
                    • Erythema (7.9-15.1%)
                    • Arthralgia (5.5-12.7%)

                  Pediatrics

                  • Moderate irritability (25-31.4%)
                  • Mild irritability (23.6-30.2%)
                  • Mild somnolence (13.9-24.2%)
                  • Mild pain (16.9-24.1%)
                  • Moderate somnolence (10-21.6%)
                  • Fever ≥38ºC (13.3-20.4%)
                  • Fever >38 to <39ºC (12.1-18.5%)
                  • Erythema ≤2.5 cm (11-15.4%)
                  • Moderate pain (8.8-14.7%)
                  • Decreased appetite, mild (7.5-12%)
                  • Induration ≤2.5 cm (7.5-11%)

                  1-10%

                  Adults

                  Fever 38ºC to <38.5ºC (0.6-1.6%)

                  • Grade 3
                    • Fatigue (1%)
                    • Pain (1%)

                  Pediatrics

                  • Swelling ≤2.5 cm (5.8-9.5%)
                  • Decreased appetite, moderate (5.7-7.9%)
                  • Erythema 2.5-7.6 cm (2.3-6.8%)
                  • Induration 2.5-7.6 cm (2.8-6.2%)
                  • Severe irritable (2.6-4.7%)
                  • Induration 2.5-7.6 cm (2.8-6.2%)
                  • Swelling 2.5-7.6 cm (3.2-5.5%)
                  • Fever ≥39 to <40ºC (0.7-2.4%)
                  • Severe somnolence (0.4-1.7%)
                  • Mild urticaria (0.8-1.7%)
                  • Moderate urticaria (0.2-1.5%)
                  • Severe pain (0.2-1.5%)

                  <1%

                  Adults

                  Fever 38.5ºC to <39ºC (0.1-0.3%)

                  Fever ≥39ºC (0.2%)

                  • Grade 3
                    • Pain (0.8-0.9%)
                    • Erythema, >10 cm (0.5-0.8%)
                    • Headache (0.4-0.8%)
                    • Myalgia (0.3-0.8%)
                    • Fatigue (0.7%)
                    • Arthralgia (0.2-0.4%)
                    • Swelling, >10 cm (0.2-0.4%)

                  Pediatrics

                  • Decreased appetite, severe (0.4-0.5%)
                  • Fever ≥40ºC (0.1-0.5%)
                  • Erythema >7.6 cm (0.2-0.3%)
                  • Severe urticaria (0.2%)
                  • Induration >7.6 cm (0.2%)
                  • Swelling >7.6 cm (0.2%)
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                  Warnings

                  Contraindications

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

                  Cautions

                  Administer in facility with appropriate medical treatment to manage allergic reactions

                  Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have reduced immune response

                  Apnea following IM observed in some infants born prematurely; consider when to administer pneumococcal vaccine 15-vaccine premature infants based on infant’s medical status and potential benefits and possible risks

                  Drug interaction overview

                  • Immunosuppressive therapies may reduce immune response to vaccine
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                  Pregnancy & Lactation

                  Pregnancy

                  No adequate and well-controlled studies have been conducted in pregnant women; data are insufficient to inform vaccine-associated risks in pregnancy

                  Animal studies

                  • Developmental toxicity studies in female rats administered a human dose have been conducted on 4 occasions (twice before mating, once during gestation, and once during lactation)
                  • These studies revealed no evidence of harm to the fetus

                  Lactation

                  Data are not available to assess vaccine impact on milk production, its presence in breast milk, or its effects on breastfed children

                  Consider developmental and health benefits of breastfeeding along with the mother’s clinical need for therapy and any potential adverse effects on breastfed children from the drug or from underlying maternal condition; for preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine

                  Pregnancy Categories

                  A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                  B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                  C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                  D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                  X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                  NA: Information not available.

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                  Pharmacology

                  Mechanism of Action

                  Protection against invasive disease conferred mainly by opsonophagocytic killing of S pneumoniae

                  Vaccine induces opsonophagocytic activity against the serotypes contained in vaccine

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                  Administration

                  IM Preparation

                  Hold syringe horizontally and shake vigorously immediately before administration to obtain an opalescent suspension

                  Discard if it cannot be resuspended

                  Inspect visually for particulate matter and discoloration; do not use if particulate matter or discoloration observed

                  IM Administration

                  For IM administration only

                  Appropriate medical treatment to manage allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration

                  Storage

                  Refrigerate at 2-8ºC (36-46ºF)

                  Do not freeze

                  Protect from light

                  Preservative-free suspension

                  Tip cap and plunger stopper of prefilled syringe are not made with natural rubber latex

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                  Images

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                  Patient Handout

                  A Patient Handout is not currently available for this monograph.
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                  Formulary

                  FormularyPatient Discounts

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                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.