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

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

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.

Pneumococcal Serotypes

Serotypes

Different serotypes can cause pneumococcal disease—

PNEUMOVAX 23 is the only pneumococcal vaccine indicated to prevent disease caused by 23 serotypes15

Serotypes contained in PCV13 and PNEUMOVAX 23

PCV13 contains
13 serotypes,
of which 1 is unique

PNEUMOVAX 23
contains 23 serotypes,
of which 11 are unique

23 serotypes in PNEUMOVAX 23 and 13 serotypes in PCV13 23 serotypes in PNEUMOVAX 23 and 13 serotypes in PCV13

Serotypes contained in both vaccines
Serotypes unique to PNEUMOVAX 23
Serotypes unique to PCV13

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

Change Over Time

Distribution of common disease-causing pneumococcal serotypes, all ages—United States, 1999-201116,a

Serotypes change over time Serotypes change over time
aEach serotype represents more than 1.0% of isolated strains in at least 1 of the time periods assessed.
Not all serotypes in this figure are included in pneumococcal vaccines.

Aged <65 Years

In adult patients aged <65 years

The serotypes in PNEUMOVAX 23 accounted for ~25% more invasive pneumococcal disease (IPD) cases compared to the percentage of IPD cases caused by serotypes in PCV1317

Percentage of all IPD cases caused by serotypes contained in each vaccine—United States (CDC 2008)17
Serotypes change over time

Represents 100% of IPD cases

Patients aged
18-49 years

Patients aged
50-64 years

The figure depicts CDC epidemiologic data and does not reflect the efficacy of the respective vaccines.

Serotypes in PNEUMOVAX 23
Serotypes in PCV13

Aged ≥65 Years

In patients aged ≥65 Years

~40%

of invasive pneumococcal disease (IPD) was caused by the 11 unique serotypes in PNEUMOVAX 23, according to the CDC in 201314

Indication

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

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.

PCV13=13-valent pneumococcal conjugate vaccine.
CDC=Centers for Disease Control and Prevention.
VACC-1101056-0018 03/17