Pharmaceutical Name

Trade (marketing or proprietary) name: PNEUMOVAX® 23

Generic (nonproprietary or active ingredient) name: PPSV23, Pneumococcal vaccine polyvalent Sterile, Liquid Vaccine for Intramuscular or Subcutaneous Injection

Indication and Usage

Reason the product has been approved for sale on the market.

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). (1.1) 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.

Manufacturer Insert

Ingredients

Also known as “excipients” for vaccines.

Each 0.5-mL dose of vaccine contains 25 micrograms of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative. The vaccine is used directly as supplied. No dilution or reconstitution is necessary.

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

Do not administer PNEUMOVAX 23 to individuals with a history of anaphylactic/anaphylactoid or severe allergic reaction to any component of the vaccine.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

Persons with Moderate or Severe Acute Illness: Defer vaccination with PNEUMOVAX 23 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 PNEUMOVAX 23 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 other antibiotic) prophylaxis against pneumococcal infection. In patients who require penicillin (or other antibiotic) prophylaxis against pneumococcal infection, such prophylaxis should not be discontinued after vaccination with PNEUMOVAX 23.

Persons with Altered Immunocompetence: Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.

Persons with Chronic Cerebrospinal Fluid Leakage: PNEUMOVAX 23 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.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

Cellulitis, Malaise, Fever (>102°F), Warmth at the injection site, Decreased limb mobility, Peripheral edema in the injected extremity, Injection-site necrosis, Nausea, Vomiting, Lymphadenitis, Lymphadenopathy, Thrombocytopenia in patients with stabilized idiopathic thrombocytopenic purpura, Hemolytic anemia in patients who have had other hematologic disorders, Leukocytosis, Hypersensitivity reactions including: Anaphylactoid reactions, Serum Sickness and Angioneurotic edema. Arthralgia, Arthritis, Paresthesia, Radiculoneuropathy, Guillain-Barré syndrome, Febrile convulsion, Rash, Urticaria, Cellulitis-like reactions, Erythema multiforme, and Increased serum C-reactive protein.

Limitations of Use

PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

Specific Populations

Pregnancy

Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk. Developmental toxicity studies have not been conducted with PNEUMOVAX 23 in animals.

Breastfeeding

It is not known whether PNEUMOVAX 23 is excreted in human milk. Data are not available to assess the effects of PNEUMOVAX 23 on the breastfed infant or on milk production/excretion.

Fertility

The insert does not have a section 13.1.

Pediatric

PNEUMOVAX 23 is not approved for use in children less than 2 years of age. Children in this age group do not develop an effective immune response to the capsular types contained in this polysaccharide vaccine.

Immunocompromised Individuals

Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

PNEUMOVAX 23 induces type-specific antibodies that enhance 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.

Analytical Deep Dive

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Alternatives

For product alternatives, please visit the Influenza webpage.