1. Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2014;63(37):822–825.
2. Centers for Disease Control and Prevention (CDC). Intervals between PCV13 and PPSV23 vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2015;64(34):944–947. (Erratum Notice: CDC. MMWR Morb Mortal Wkly Rep. 2015;64(42):1204.)
3. Centers for Disease Control and Prevention (CDC). Storage and handling. In: Hamborsky J, Kroger A, Wolfe S, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:63–78.
4. Prevnar 13 [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2017.
5. Centers for Disease Control and Prevention (CDC). Pneumococcal vaccination among Medicare beneficiaries occurring after the Advisory Committee on Immunization Practices recommendation for routine use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults aged ≥ 65 years. MMWR Morb Mortal Wkly Rep. 2017;66(27):728–733.
6. Centers for Disease Control and Prevention (CDC). Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2012;61(40):816–819.
7. American Diabetes Association. Standards of medical care in diabetes—2018. Diabetes Care. 2018;41(suppl 1):S1–S159.
8. American Association of Diabetes Educators (AADE). Vaccination practices for people with diabetes: AADE practice synopsis. https://www.diabeteseducator.org/docs/default-source/practice/practice-resources/synopsis/vaccination-practices-for-people-with-diabetes.pdf?sfvrsn=0. Published October 7, 2015. Accessed June 11, 2018.
9. Handelsman Y, Bloomgarden ZT, Grunberger G, et al. American Association of Clinical Endocrinologists and American College of Endocrinology—clinical practice guidelines for developing a diabetes mellitus comprehensive care plan—2015. Endocr Pract. 2015;21(suppl 1):1−87.
10. Amsterdam EA, Wenger NK, Brindis RG, et al. 2014 AHA/ACC guideline for the management of patients with non–st-elevation acute coronary syndromes. J Am Coll Cardiol. 2014;64(24):e139−e228.
11. Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007;44(suppl 2):S27−S72.
12. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. 2018 report. Updated November 20, 2017. http://goldcopd.org/wp-content/uploads/2017/11/GOLD-2018-v6.0-FINAL-revised-20-Nov_WMS.pdf. Accessed March 5, 2018.
13. Shea KM, Edelsberg J, Weycker D, et al. Rates of pneumococcal disease in adults with chronic medical conditions. Open Forum Infect Dis. 2014;1(1):1–9.
14. Petigara T, Zhang D. Pneumococcal vaccine coverage in adults aged 19–64 years, newly diagnosed with chronic conditions in the U.S. Am J Prev Med. 2018;54(5):630–636.
15. Butler JC, Breiman RF, Campbell JF, et al. Pneumococcal polysaccharide vaccine efficacy: an evaluation of current recommendations. JAMA. 1993;270(15):1826–1831.
16. Centers for Disease Control and Prevention (CDC). Pneumococcal disease: surveillance and reporting. cdc.gov/pneumococcal/surveillance.html. Accessed March 6, 2018.
17. Centers for Medicare & Medicaid Services. Modifications to Medicare Part B coverage of pneumococcal vaccinations. http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles
/Downloads/MM9051.pdf. Accessed August 24, 2017.
18. National Committee for Quality Assurance (NCQA). HEDIS® 2018 Measures. http://www.ncqa.org/hedis-quality-measurement/hedis-measures/hedis-2018. Accessed November 7, 2017.
19. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1163180-0002.
20. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1246827-0001.
21. Centers for Disease Control and Prevention (CDC). Noninfluenza vaccination coverage among adults - United States, 2011. MMWR Morb Mortal Wkly Rep. 2013;62(4):66–72.

Indication

PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) 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.

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

Select Safety Information for PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)

Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.

Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.

Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

PNEUMOVAX 23 should be given to a pregnant woman only if clearly needed.

Caution should be exercised when PNEUMOVAX 23 is administered to a nursing woman.

Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.

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

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.

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

For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination.

Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

Before administering PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent), please read the accompanying Prescribing Information. The Patient Information also is available.

CDC recommends appropriate immunocompetent adults 65 years of age and older receive PNEUMOVAX 23 as part of a 2-vaccine sequential regimen1,2

  • Pneumococcal Vaccine Recommendations for Adults Aged 65 Years and Older

    Pneumococcal Vaccine Recommendations for Adults Aged 65 Years and Older

    CDC-recommended sequential administration and intervals for vaccination of immunocompetent adults aged 65 years and older2,a,b

    • For pneumococcal vaccine-naïve persons aged ≥65 years
      Administer PCV13
      at age ≥65 years

      at least 1 year later

      Administer
      PNEUMOVAX 23 (PPSV23)
    • For persons who previously received PNEUMOVAX 23 at age ≥65 years
      PNEUMOVAX 23 already
      received at age ≥65 years

      at least 1 year later

      Administer
      PCV13
    • For persons who previously received PNEUMOVAX 23 before age 65 years who are now aged ≥65 years
      PNEUMOVAX 23 already
      received at age <65 years

      at least 1 year later

      Administer PCV13
      at age ≥65 years

      at least 1 year later, and at least 5 years after receiving initial dose of PNEUMOVAX 23

      Administer
      PNEUMOVAX 23
    • PCV13=13-valent pneumococcal conjugate vaccine.

      PPSV23=23-valent pneumococcal polysaccharide vaccine.

      aIf a dose of PNEUMOVAX 23 is given earlier than the recommended interval, the dose need not be repeated.

      bPNEUMOVAX 23 and PCV13 should not be coadministered.

    Important Considerations

    • There are limited data on the sequential administration of PNEUMOVAX 23 (PPSV23) with other vaccines, including PCV13.
    • An immunogenicity study described in the Prescribing Information for PCV13 evaluated the sequential administration with PNEUMOVAX 23 (PPSV23) in adults aged 60–64 years4:

      Diminished immune response with one dose of PNEUMOVAX 23 (PPSV23) followed by a dose of PCV13 one year later vs PCV13 alone

      Noninferior immune response with one dose of PCV13 followed by a dose of PNEUMOVAX 23 (PPSV23) one year later vs PNEUMOVAX 23 (PPSV23) alone

    • The levels of antibodies that correlate with protection against pneumococcal disease have not been clearly defined.
    • Routine revaccination of immunocompetent persons previously vaccinated with a 23-valent vaccine is not recommended.
    • For subjects aged ≥65 years in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine- related were higher following revaccination with PNEUMOVAX 23 (PPSV23) than following initial vaccination with PNEUMOVAX 23 (PPSV23).
  • Pneumococcal Vaccination Opportunities

    Pneumococcal Vaccination Opportunities

    According to a CDC retrospective analysis of eligible immunocompetent patients aged ≥65 years
    According To a CDC Retrospective Analysis of Eligible Immunocompetent Patients 65 Years and Older, ~1 Out of 5 Have Completed Their CDC-Recommended 2-Vaccine Sequential RegimenAccording To a CDC Retrospective Analysis of Eligible Immunocompetent Patients 65 Years and Older, ~1 Out of 5 Have Completed Their CDC-Recommended 2-Vaccine Sequential Regimen
    ~1 out of 5
    have completed their CDC-recommended
    pneumococcal 2-vaccine
    sequential regimen5,c
    Not actual patients
    cStudy Design: As a proxy for estimating PCV13 and PNEUMOVAX 23 vaccination coverage among adults aged ≥65 years before and after implementation of the CDC 2014 pneumococcal vaccine recommendations, the CDC analyzed pneumococcal vaccination claims submitted for reimbursement to the Centers for Medicare and Medicaid Services among Medicare Part A and B beneficiaries aged ≥65 years from September 19, 2009, through September 18, 2016. PCV13 and PNEUMOVAX 23 claims from hospitals and outpatient settings were identfied by the use of Current Procedural Terminology (CPT) codes. Claims submitted for at least one dose of PCV13 (regardless of PNEUMOVAX 23 status), at least one dose of PNEUMOVAX 23 (regardless of PCV13 status), at least one dose each of PCV13 and PNEUMOVAX 23, and at least one dose of either vaccine were included and stratified by age, race/ethnicity, state, and the presence of chronic or immunocompromising conditions for which PCV13, PNEUMOVAX 23, or both vaccines are indicated.

Indication

PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) 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.

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

Select Safety Information for PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)

Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.

Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.

Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.

PNEUMOVAX 23 should be given to a pregnant woman only if clearly needed.

Caution should be exercised when PNEUMOVAX 23 is administered to a nursing woman.

Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.

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

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.

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

For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination.

Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

Before administering PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent), please read the accompanying Prescribing Information. The Patient Information also is available.

CDC=Centers for Disease Control and Prevention.
CPT=Current Procedural Terminology. Copyright © 2018 American Medical Association.
All Rights Reserved. CPT is a registered trademark of American Medical Association.
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