Pneumococcal Vaccine induces type-specific antibodies that enhanced opsonization, phagocytosis, and killing of pneumococci by leukocytes and other phagocytic cells. The levels of antibodies that correlate with protection against pneumococcal disease have not been clearly defined.

Polysaccharide Pneumococcal Vaccine 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). Polysaccharide Pneumococcal Vaccine 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.

Preparation:

• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If either of these two conditions exists, the vaccine should not be administered.
• Do not mix Pneumococcal Vaccine with other vaccines in the same syringe or vial.
• Use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another.

Single-Dose Vial: Withdraw 0.5 mL from the vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents.

Single-Dose, Prefilled Syringe: The package does not contain a needle. Attach a sterile needle to the prefilled syringe by twisting in a clockwise direction until the needle fits securely on the syringe.

Administration:

Administer Pneumococcal Vaccine intramuscularly or subcutaneously into the deltoid muscle or lateral mid-thigh. Do not inject intravascularly or intradermally.

Single-Dose Vial: Administer a single 0.5-mL dose of Pneumococcal Vaccine using a sterile needle and syringe. Discard vial after use.

Single-Dose, Prefilled Syringe: Administer the entire contents of the single-dose, prefilled syringe per standard protocol using a sterile needle. Discard syringe after use.

Revaccination: The Advisory Committee on Immunization Practices (ACIP) has recommendations for revaccination against pneumococcal disease for persons at high risk who were previously vaccinated with Pneumococcal Vaccine. Routine revaccination of immunocompetent persons previously vaccinated with a 23-

valent vaccine, is not recommended.

Do not administer Pneumococcal Vaccine to individuals with a history of anaphylactic/anaphylactoid or severe allergic reaction to any component of the vaccine.

The most common adverse reactions, reported in >10% of subjects vaccinated with p neumococcal vaccine for the first time in a clinical trial, 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%).

Persons with Moderate or Severe Acute Illness: Defer vaccination with Pneumococcal Vaccine in persons with moderate or severe acute illness.

Persons with Severely Compromised Cardiovascular or Pulmonary Function: Caution and appropriate care should be exercised in administering Pneumococcal Vaccine to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

Use of Antibiotic Prophylaxis: This vaccine does not replace the need for penicillin (or another antibiotic) prophylaxis against pneumococcal infection. In patients who require penicillin (or another antibiotic) prophylaxis against pneumococcal infection, such prophylaxis should not be discontinued after vaccination with Pneumococcal Vaccine.

Persons with Altered Immunocompetence: Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to Pneumococcal Vaccine.

Persons with Chronic Cerebrospinal Fluid Leakage: Pneumococcal Vaccine may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures, or neurosurgical procedures.

Use in Special Populations

Pediatrics: Pneumococcal vaccine 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.