Pneumovax 23

  • Indications and Usage

    • PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).

    • PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged >2 years who are at increased risk for pneumococcal disease.
  • Dosage and Administration

    Single 0.5-mL dose of PNEUMOVAX 23 administered intramuscularly or subcutaneously only.

  • Dosage Forms and Strengths

    Clear, sterile solution supplied in a (0.5-mL dose) single-dose vial and a multidose (5-dose) vial.

  • Contraindications

    • Severe allergic reaction (e.g., anaphylaxis) to any component of PNEUMOVAX 23.

  • Adverse Reactions

    • The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 in clinical trials, were: injection-site pain/soreness/tenderness (60.0%), injection-site swelling/induration (20.3%), headache (17.6%), injection-site erythema (16.4%), asthenia and fatigue (13.2%), and myalgia (11.9%).

  • Use in Specific Populations

    • Pregnancy: No human or animal data are available. Use only if clearly needed.
    • Pediatrics: PNEUMOVAX23 is not approved for use in children younger than 2 years of age because children in this age group do not develop an effective immune response to capsular types contained in the polysaccharide vaccine.
    • Geriatrics: For subjects aged 65 years or older in a clinical study systemic adverse reactions, determined by the investigator to be vaccine-related, were higher following revaccination (33.1%) than following initial vaccination (21.7%). Routine revaccination of immunocompetent persons previously vaccinated with a 23-valent vaccine, is not recommended.
    • Immunocompromised Individuals: Response to vaccination may be diminished.