Pneumovax 23

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Pneumovax 23 Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Pneumococcal vaccine polyvalent; contains a total of 575mcg polysaccharides per 0.5mL; soln for IM or SC inj; contains phenol.

    Pharmacological Class

    PCV.

    How Supplied

    Single-dose vials—10; Single-dose prefilled syringes—10

    Storage

    • Store at 2-8°C (36-46°F). All vaccine must be discarded after the expiration date.

    Manufacturer

    Merck & Co., Inc.

    Mechanism of Action

    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.

    Pneumovax 23 Indications

    Indications

    Active immunization for the prevention of pneumococcal disease caused by S. pneumoniae serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F in adults aged ≥50 years and children aged ≥2 years who are at increased risk for pneumococcal disease.

    Pneumovax 23 Dosage and Administration

    Adults and Children

    Give by IM or SC inj into the deltoid muscle or lateral mid-thigh. <2yrs: not recommended. ≥2yrs: 1 dose (0.5mL).

    Pneumovax 23 Contraindications

    Not Applicable

    Pneumovax 23 Boxed Warnings

    Not Applicable

    Pneumovax 23 Warnings/Precautions

    Warnings/Precautions

    Not for routine revaccination after previous vaccination with a 23-valent vaccine in immunocompetent patients. Severe cardiac or pulmonary disease where a systemic reaction would pose a significant risk. Defer vaccination in moderate or severe acute illness. Do not discontinue antipneumococcal prophylactic antibiotic therapy. Immunocompromised. Chronic CSF leakage. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Persons with Moderate or Severe Acute Illness

    • Defer vaccination in persons with moderate or severe acute illness.

    Persons with Severely Compromised Cardiovascular or Pulmonary Function

    • Exercise caution and use appropriate care when vaccinating individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

    Use of Antibiotic Prophylaxis

    • Pneumovax 23 does not replace the need for penicillin (or other antibiotic) prophylaxis against pneumococcal infection.

    • After vaccination with Pneumovax 23, do not discontinue antipneumococcal prophylactic antibiotic therapy.

    Persons with Altered Immunocompetence

    • May have a diminished immune response in immunocompromised individuals, including those receiving immunosuppressive therapy.

    Persons with Chronic Cerebrospinal Fluid Leakage 

    • 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.

    Pregnancy Considerations

    Risk Summary

    • Available human data have not established the presence or absence of a vaccine-associated risk.

    Nursing Mother Considerations

    Risk Summary

    • Not known whether Pneumovax 23 is excreted in human milk.

    • No available data to assess the effects of Pneumovax 23 on the breastfed infant or on milk production/excretion.

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Pneumovax 23 and any potential adverse effects on the breastfed child from Pneumovax 23 or from the underlying maternal condition.

    Pediatric Considerations

    • Not approved for use in children less than 2 years of age.

    Other Considerations for Specific Populations

    Immunocompromised Individuals

    • May have a diminished immune response in immunocompromised individuals, including those receiving immunosuppressive therapy.

    Pneumovax 23 Pharmacokinetics

    See Literature

    Pneumovax 23 Interactions

    Interactions

    Separate administration of Pneumovax 23 and Zostavax vaccines by at least 4 weeks.

    Pneumovax 23 Adverse Reactions

    Adverse Reactions

    Inj site reactions, headache, asthenia/fatigue, myalgia.

    Pneumovax 23 Clinical Trials

    Clinical Trials

    Effectiveness

    • 2 controlled studies in South Africa evaluated the efficacy of pneumococcal vaccines containing six (types 1, 2, 4, 8, 12F, and 25) or twelve (types 1, 2, 3, 4, 6A, 8, 9N, 12F, 25, 7F, 18C, and 46) capsular polysaccharides in male novice gold miners ranging in age from 16 to 58 years who had a high attack rate for pneumococcal pneumonia and bacteremia. In both studies, patients received either meningococcal polysaccharide serogroup A or placebo. The 6- and 12-valent vaccines achieved a protective efficacy of 76% and 92%, respectively, for the capsular types.

    • 3 similar studies in South Africa evaluated the efficacy of pneumococcal vaccines containing 6 (types 1, 3, 4, 7, 8, and 12) or 13 (types 1, 2, 3, 4, 6, 7, 8, 9, 12, 14, 18, 19, and 25) capsular polysaccharides in young adult male novice gold miners. The vaccines achieved a 79% reduction in pneumococcal pneumonia caused by the capsular types and a 82% reduction in type-specific pneumococcal bacteremia.

    • A prospective study in France evaluated the efficacy of a pneumococcal vaccine containing 14 (types 1, 2, 3, 4, 6A, 7F, 8, 9N, 12F, 14, 18C, 19F, 23F, and 25) capsular polysaccharides in male and female nursing home residents with a mean age of 74. The vaccine achieved a 77% efficacy in reducing the incidence of pneumonia.

    • A study evaluated a pneumococcal vaccine containing 8 (types 1, 3, 6, 7, 14, 18, 19, and 23) capsular polysaccharides in children and young adults aged 2 to 25 years with sickle cell disease, congenital asplenia, or undergone a splenectomy. Vaccinated patients had a significantly lower incidence of bacteremic pneumococcal disease compared with unvaccinated patients.

    • In a retrospective cohort analysis study based on the US CDC pneumococcal surveillance system, the overall protective efficacy was 57% against invasive infections caused by serotypes included in Pneumovax 23 in persons 6 years of age and older. The overall efficacy was 65–84% among specific patients groups (eg, diabetes mellitus, coronary vascular disease, congestive heart failure, chronic pulmonary disease, and anatomic asplenia). The overall efficacy was 75% in immunocompetent persons aged 65 years and older.

    Immunogenicity

    Sequential Administration of Prevnar 13 and Pneumovax 23

    • A randomized, double-blind, placebo-controlled, multicenter study evaluated the sequential administration of Prevnar 13 and Pneumovax 23 in 400 healthy adults 50 years of age and older. Patients received Prevnar 13 followed by Pneumovax 23 or placebo either 8 weeks later (Group 1) or 26 weeks later (Group 2). Of these, 188 subjects received Pneumovax 23 (Group 1) and 185 subjects received placebo (Group 2) at Week 8, and 172 subjects received placebo (Group 1) and 164 subjects received Pneumovax 23 (Group 2) at Week 26.

    • For each of the shared serotypes, Week 12 OPA geometric mean titers (GMTs) in Group 1 were noninferior to those of Group 2, as the lower bounds of the 95% CIs for the OPA GMT ratios were >0.5 for all 12 shared serotypes. 

    • For serotypes 22F and 33F, OPA GMTs in Group 1 at Week 12 were superior to those of Group 2 at Week 12, as the lower bounds of the 95% CIs for the OPA GMT ratios were >2.0 for both serotypes. The OPA GMTs to the 12 shared serotypes and 2 unique serotypes (22F and 33F) when measured 4 weeks after dosing with Pneumovax 23 were generally similar between Group 1 (Week 12) and Group 2 (Week 30 subset).

    Pneumovax 23 Note

    Not Applicable

    Pneumovax 23 Patient Counseling

    Patient Counseling

    • Inform the patient, parent or guardian of the benefits and risks associated with vaccination. 

    • Tell the patient, parent or guardian that vaccination with Pneumovax 23 may not offer 100% protection from pneumococcal infection. 

    • Provide the patient, parent or guardian with the vaccine information statements required by the National Childhood Vaccine Injury Act of 1986, with each immunization. 

    • Instruct the patient, parent or guardian to report any serious adverse reactions to their health care provider who in turn should report such events to the vaccine manufacturer or the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967, or report online at www.vaers.hhs.gov.

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