PNEUMOVAX 23 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).

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 conditions
1:

Multiple professional organizations are consistent with the CDC’s recommendation of pneumococcal vaccination for appropriate adults with certain chronic conditions1,8,9,10,11,12,13
DIABETES MELLITUS CHRONIC HEART DISEASE CHRONIC LUNG DISEASE
(COPD)
  • American Diabetes Association8
  • American Association of
    Diabetes Educators9
  • American Association of
    Clinical Endocrinologists/
    American College of Endocrinology10
  • American Heart Association11
  • American College of Cardiology11
  • American Thoracic
    Society12
  • Global Initiative for Chronic Obstructive Lung
    Disease13
Multiple professional organizations are consistent with the CDC’s recommendation of pneumococcal vaccination for appropriate adults with certain chronic conditions 1,8,9,10,11,12,13
DIABETES MELLITUS 
  • American Diabetes Association8
  • American Association of Diabetes Educators9
  • American Association of Clinical Endocrinologists / American College of Endocrinology10
CHRONIC HEART DISEASE
  • American Heart Association11
  • American College of Cardiology11
CHRONIC LUNG DISEASE (COPD)
  • American Thoracic Society12
  • Global Initiative for Chronic Obstructive Lung Disease13
Adults aged <65 years with these chronic conditions have an increased risk for IPD versus healthy adults of the same age14,a
DIABETES MELLITUS CHRONIC HEART DISEASE CHRONIC LUNG DISEASE
(COPD)
~3X RISK ~3X RISK ~7X RISK
Adults aged <65 years with these chronic conditions have an increased risk for IPD versus healthy adults of the same age14,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 201615,b
DIABETES MELLITUS CHRONIC HEART DISEASE CHRONIC LUNG DISEASE
(COPD)
~21% VACCINATION RATE 13% VACCINATION RATE ~17% VACCINATION RATE
Yet vaccination rates remained low 5 years after initial diagnosis, according to a separate study from 201615,b
DIABETES MELLITUS 

~21% VACCINATION RATE

CHRONIC HEART DISEASE

13% VACCINATION RATE

CHRONIC LUNG DISEASE (COPD)

~17% VACCINATION RATE

  1. 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.14
  1. 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 claims.15

CPT=Current Procedural Terminology. Copyright © 2020. American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association.

Watch Dr. Sethu Reddy of the Cleveland Clinic discuss potential vaccination opportunities for appropriate patients with diabetes mellitus
Video
Watch Dr. Sethu Reddy of the Cleveland Clinic discuss potential vaccination opportunities for appropriate patients with diabetes mellitus
ref1

Reference

  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: updated recommendations of the Advisory Committee on Immunization Practices. MMWR. 2019;68(46):1069–1075.
ref6

Reference

  1. Centers for Disease Control and Prevention (CDC). Adult Vax View. Pneumococcal vaccination among U.S. Medicare beneficiaries aged ≥65 years, 2009-2017. https://www.cdc.gov/vaccines/imz-managers/coverage/adultvaxview/pubs-resources/pcv13-medicarebeneficiaries.html. Updated September 4, 2018. Accessed January 24, 2020.
ref8

Reference

  1. American Diabetes Association. Standards of medical care in diabetes—2019. Diabetes Care. 2019;42(suppl 1):S1–S193.
ref9

Reference

  1. American Association of Diabetes Educators (AADE). Vaccination practices for people with diabetes: AADE practice synopsis. https://www.diabeteseducator.org/docs/default-source/practice/educator-tools/vaccination-practices-for-adults-with-diabetesv2.pdf. Published 2019. Accessed November 12, 2019.
ref10

Reference

  1. 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.
ref11

Reference

  1. 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.
ref12

Reference

  1. 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.
ref13

Reference

  1. 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. Published 2018. Accessed November 12, 2019.
ref14

Reference

  1. 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.
ref15

Reference

  1. 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.

Indication for PNEUMOVAX 23

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.

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.

Do not administer PNEUMOVAX® 23 (Pneumococcal Vaccine Polyvalent) 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.

Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk.

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, please read the accompanying Prescribing Information. The Patient Information also is available.

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.


US-PNX-00807 02/20