1. 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.
2. 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.
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. 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.
5. Boyanova L, Mitov I. Antibiotic resistance rates in causative agents of infections in diabetic patients: rising concerns. Expert Rev Anti Infect Ther. 2013;11(4):411–420.
6. Lung congestion. Encyclopedia Britannica. http://www.britannica.com/EBchecked/topic/351528/lung-congestion. Accessed April 4, 2016.
7. Ware LB, Matthay MA. Clinical practice. Acute pulmonary edema. N Engl J Med. 2005;353(26):2788–2796.
8. Mor A, Thomsen RW, Ulrichsen SP, et al. Chronic heart failure and risk of hospitalization with pneumonia: a population-based study. Eur J Intern Med. 2013;24(4):349–353.
9. Barnes PJ. Cellular and molecular mechanisms of chronic obstructive pulmonary disease. Clin Chest Med. 2014;35(1):71–86.
10. American Diabetes Association. Standards of medical care in diabetes—2016. Diabetes Care. 2016;39 (suppl 1):S1–S112.
11. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1131463-0001.
12. 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. doi:10.1016/j.jacc.2014.09.017.
13. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2016. http://www.goldcopd.org/global-strategy-diagnosis-management-prevention-copd-2016/. Accessed October 4, 2016.
14. 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.)
15. Prevnar 13 [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2016.
16. Richter SS, Heilmann KP, Dohrn CL, et al. Pneumococcal serotypes before and after introduction of conjugate vaccines, United States, 1999–2011. Emerg Infect Dis. 2013;19(7):1074–1083.
17. Centers for Disease Control and Prevention (CDC); Advisory Committee on Immunization Practices. Updated recommendations for prevention of invasive pneumococcal disease among adults using the 23-valent pneumococcal polysaccharide vaccine (PPSV23). MMWR Morb Mortal Wkly Rep. 2010;59(34):1102−1106.
18. Butler JC, Breiman RF, Campbell JF, et al. Pneumococcal polysaccharide vaccine efficacy: an evaluation of current recommendations. JAMA. 1993;270(15):1826–1831.
19. Taitel M, Cohen E, Duncan I, et al. Pharmacists as providers: targeting pneumococcal vaccinations to high risk populations. Vaccine. 2011;29(45):8073–8076. doi:10.1016/j.vaccine.2011.08.051.
20. National Foundation for Infectious Diseases (NFID). Survey: disconnect in what doctors think they say about vaccines and what patients hear. http://www.nfid.org/newsroom/news-conferences/2010-news-conferences/2010-cdc-vaccination-rates-news-conference/2010-survey-backgrounder.pdf. Published November 2010. Accessed April 4, 2016.
21. Centers for Disease Control and Prevention (CDC). Prevention of pneumococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 1997;46(RR-8):1–24.

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.

Effectiveness

In a 14-year retrospective study—

PNEUMOVAX 23 demonstrated reduction of disease in adults18,a

Effectiveness demonstrated against invasive pneumococcal infections caused by serotypes in the vaccine18,a,b

57%

Overall in all populations (N=2,837)

Diabetes
Mellitus
84%

Coronary Vascular
Disease
73%

Congestive Heart
Failure
69%

Chronic Pulmonary
Disease
65%

Aged ≥65 years
(Immunocompetent)
75%

aEffectiveness was evaluated using the 14- or 23-capsular pneumococcal polysaccharide vaccine.
bVaccine effectiveness could not be confirmed for certain groups of immunocompromised patients.

Study Design

In a US retrospective indirect cohort study covering18

  • A 14-year period (1978–1992)
  • 54 hospitals
  • 26 states

Patients eligible for inclusion were ≥2 years of age with a known vaccination status/date, who were monitored for illness during this period, and from whom pneumococcus was isolated from blood or cerebrospinal fluid (CSF). The median age of vaccinated patients was 57 years; the median age of unvaccinated patients was 50 years. Vaccine effectiveness was estimated by comparing the distribution of disease-causing pneumococcal serotypes in vaccinated (eg, received either the 14-valent or 23-valent pneumococcal polysaccharide vaccines) and unvaccinated persons. Vaccine effectiveness was also estimated for study participants with underlying medical conditions.18

Learn more about 4 additional studies of efficacy and effectiveness in section 14.1 of the Prescribing Information

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.

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