PNEUMOCOCCAL VACCINE INJ
Clinical Criteria Summary
Indication(s)
- Prevention of invasive pneumococcal disease (IPD) and pneumonia caused by serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B.
Patient Population
- Individuals 18 years of age and older.
- Specifically studied in adults ≥50 years, adults 18–49 years with underlying chronic conditions increasing IPD risk, adults living with HIV, vaccine-naïve individuals, and previously vaccinated individuals.
- Comorbidities known to increase pneumococcal disease risk include diabetes, renal disorders, chronic heart disease, chronic lung disease, chronic liver disease, and alcoholism.
Dosing & Administration
- Supplied as a single-dose prefilled syringe (refrigerated).
- Recommended as a single dose for adults ≥50 years.
Contraindications, Warnings & Precautions
- Contraindicated in patients with a history of severe allergic reaction to any component of CAPVAXIVE or diphtheria toxoid.
- Warning regarding prevention and management of allergic reactions and syncope following administration.
- Precaution: Immunocompromised individuals may have a diminished immune response.
Safety & Adverse Reactions
- Most commonly reported solicited adverse events: injection site pain, fatigue, and headache.
- Rates and severity of solicited adverse events are similar with or without concomitant influenza vaccine.
- No cases of Guillain-Barre syndrome reported in clinical trials.
Clinical Guidance & Place in Therapy
- ACIP recommends a single dose of PCV20, PCV21, or PCV15 (the latter followed by a dose of PPSV23) for ALL adults ≥50 years, regardless of underlying conditions, with no preference among the three.
- PCV21 covers 85% of serotypes associated with adult IPD compared to 54% coverage for PCV20.
- PCV15 or PCV20 may be preferred in situations where high incidence of serotype 4 is suspected (>30% of IPD cases), as PCV21 lacks coverage for this serotype. High serotype 4 incidence has been noted in Alaska, Colorado, the Navajo Nation, New Mexico, and Oregon.
Limitations & Efficacy Data
- Approval based on immunobridging data (OPA geometric mean antibody titers); no clinical efficacy data are available.
- An opsonophagocytic activity (OPA) titer predictive of protection has not been established for any pneumococcal conjugate vaccine.