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. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1222858-0000.
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. 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.
8. American Diabetes Association. Standards of medical care in diabetes—2017. Diabetes Care. 2017;40(suppl 1):S25–S32.
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. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2017. http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/. Accessed August 9, 2017.
12. 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.
13. Centers for Disease Control and Prevention (CDC). Vaccination coverage among adults in the United States, NHIS, 2015. cdc.gov/vaccines/imz-managers/coverage/adultvaxview/coverage-estimates/2015.html. Accessed August 18, 2017.
14. US Department of Health and Human Services. Healthy People 2020: Immunization and Infectious Diseases. healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives. Accessed August 18, 2017.
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. Updated June 21, 2016. Accessed August 24, 2017.
17. Pilishvili T, Ahmed S, Xing W, et al. Impact of 13-valent pneumococcal conjugate vaccine use in the US on invasive pneumococcal disease (IPD) among adults with chronic conditions. Poster #0638. Presented at: 10th International Symposium on Pneumococci and Pneumococcal Diseases; June 26–30, 2016; Glasgow, Scotland.
18. 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.
19. National Committee for Quality Assurance (NCQA). HEDIS® 2018 Measures. http://www.ncqa.org/hedis-quality-measurement/hedis-measures/hedis-2018. Accessed November 7, 2017.
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-1163180-0002.
21. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1163180-0012.
22. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1163180-0005.

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 sequential 2-vaccine regimen1,2

  • Recommendations for Adults Aged 65 Years and Older

    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

    Pneumococcal vaccination history will determine the use of each vaccine in this patient population

    Pneumococcal vaccine-naïve persons aged ≥65 years

    Pneumococcal vaccination history will determine the use of PCV13 and PPSV23 in this patient population

    Persons who previously received PNEUMOVAX 23 at age ≥65 years

    Pneumococcal vaccination history will determine the use of PCV13 and PPSV23 in this patient population

    Persons who previously received PNEUMOVAX 23 before age 65 years who are now aged ≥65 years

    Pneumococcal vaccination history will determine the use of PCV13 and PPSV23 in this patient population

    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).
  • Vaccination Opportunities

    Vaccination Opportunities

    How many of your patients who received PCV13 may still need to complete the CDC-recommended pneumococcal vaccination regimen with PNEUMOVAX 23?

    According to projected estimates from QuintilesIMS,c from October 2014 through December 2016 in the clinic or pharmacy setting

    Of the ~15 million adults aged ≥65 years who received PCV13, ~10 million may still need PNEUMOVAX 23 in order to complete the CDC-recommended sequential 2-vaccine regimen5,d

    PCV13 recipients by completion status of the pneumococcal vaccination regimen (N=~15,000,000)

    • No claim for PNEUMOVAX 23 at age years
    • Claim for PNEUMOVAX 23 at age ≥65 years prior to PCV13
    • Claim for PNEUMOVAX 23 at age ≥65 years subsequent to PCV13
    cMerck Custom Study using QuintilesIMS Health Real-World Data Pre-adjudicated Claims.
    dStudy Design: QuintilesIMS identified PCV13 recipients aged ≥65 years during a selection period from October 2014 through December 2016. For those identified as receiving PCV13 during the selection period, PNEUMOVAX 23 vaccination history was assessed via clinic and pharmacy claims databases over a “look back” period of up to 5 years since receipt of PCV13 and a “look forward” period of up to 27 months following receipt of PCV13. The “look back” was designed to estimate the number of adults who received PNEUMOVAX 23 at age ≥65 years prior to receipt of PCV13. The “look forward” was designed to estimate the number of adults who received PNEUMOVAX 23 at age ≥65 years subsequent to receipt of PCV13.
    Limitations: Based on the sample methodology used by QuintilesIMS, PNEUMOVAX 23 vaccination for individuals identified as PCV13 recipients may be under- reported. For example, a patient identified as receiving PCV13 in a sample clinic or sample pharmacy may have received a prior pneumococcal vaccination in a non-sample location. Based on the 5-year “look back” schedule used by QuintilesIMS, PNEUMOVAX 23 vaccination for individuals identified as receiving PCV13 at age >70 years may be under-reported. For example, a patient identified as receiving PCV13 at age 71 years may have received PNEUMOVAX 23 at age 65 years, outside of the 5-year “look back” period. QuintilesIMS included extrapolated data for the findings to account for missing claims. Neither QuintilesIMS nor Merck guarantee that every patient claim in either clinic or pharmacy was reported. Merck does not independently verify this information from QuintilesIMS.

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.
VACC-1101056-0024 05/18