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 Pneumococcal Vaccination Recommendations for Patients Aged Under 65 Years With Certain Chronic Conditions

Administer 1 dose of PNEUMOVAX 23 at the time of diagnosis for appropriate adults aged under 65 years with these conditions6:

  • Professional Organization Recommendations

    Multiple professional organizations are consistent with the CDC’s recommendation of pneumococcal vaccination for appropriate adults with certain chronic conditions6-12
    • diabetes mellitus
      • American Diabetes Association7
      • American Association of Diabetes Educators8
      • American Association of Clinical Endocrinologists/American College of Endocrinology9
    • chronic heart disease
      • American Heart Association10
      • American College of Cardiology10
    • chronic lung disease (COPD)
      • American Thoracic Society11
      • Global Initiative for Chronic Obstructive Lung Disease12
  • Increased IPD Risk, Low Vaccination Rates

    Adults aged <65 years with these chronic conditions have an increased risk for IPD versus healthy adults of the same age13,a

    • diabetes mellitus
      ~3X RISK
    • chronic heart disease
      ~3X RISK
    • chronic lung disease (COPD)
      ~7X RISK
    Yet vaccination rates remained low 5 years after initial diagnosis, according to a separate study from 201614,b
    • diabetes mellitus
      ~21% vaccination rate
    • chronic heart disease
      13% vaccination rate
    • chronic lung disease (COPD)
      ~17% vaccination rate
    aStudy Design: Retrospective cohort study (adults 18–64 years of age) using data from January 1, 2006, through December 31, 2010, from 3 health care claims databases representing >35 million insured adults. Risk for IPD was compared to age-matched healthy counterparts.13
    bStudy Design:A 2016 retrospective cohort study of 552,942 adults aged 19 to 64 years diagnosed with at least one new chronic medical condition from 2009 to 2013 was conducted using the Truven Health MarketScan® Commercial Claims and Encounters database to assess pneumococcal vaccination status. After diagnosis, the follow-up period ranged from 1 to 6 years. Chronic conditions were identified using ICD-9-CM diagnosis codes; date of diagnosis was determined by the first ICD code recorded. Pneumococcal vaccination was identified using Current Procedural Terminology (CPT) codes for medical claims and National Drug Code (NDC) numbers for pharmacy claims14
aStudy Design: Retrospective cohort study (adults 18–64 years of age) using data from January 1, 2006, through December 31, 2010, from 3 health care claims databases representing >35 million insured adults. Risk for IPD was compared to age-matched healthy counterparts.13
bStudy Design:A 2016 retrospective cohort study of 552,942 adults aged 19 to 64 years diagnosed with at least one new chronic medical condition from 2009 to 2013 was conducted using the Truven Health MarketScan® Commercial Claims and Encounters database to assess pneumococcal vaccination status. After diagnosis, the follow-up period ranged from 1 to 6 years. Chronic conditions were identified using ICD-9-CM diagnosis codes; date of diagnosis was determined by the first ICD code recorded. Pneumococcal vaccination was identified using Current Procedural Terminology (CPT) codes for medical claims and National Drug Code (NDC) numbers for pharmacy claims14

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; COPD=chronic obstructive pulmonary disease. CPT=Current Procedural Terminology.
Copyright © 2018 American Medical Association. All Rights Reserved. CPT is a registered trademark of American Medical Association.
ICD-9=International Statistical Classification of Diseases and Related Health Problems–9th Revision. © American Medical Association.
All Rights Reserved. ICD-9 is a registered trademark of American Medical Association. IPD=invasive pneumococcal disease.
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