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).

Patients 19-64 Years Old With Chronic Conditions

Dr. Vincent Hsu reviews the CDC recommendations for adults 19-64 with certain chronic conditions that put them at higher risk for pneumococcal disease compared to healthy adults of the same age.14,a

  • The CDC specifically recommends 1 dose of PNEUMOVAX 23 at the time of diagnosis for patients with diabetes, chronic heart disease, or chronic lung disease (COPD).1
  • Multiple professional organizations, such as the American Diabetes Association, the American Heart Association, and the American Thoracic Society are consistent with the CDC’s recommendation.1,8,9,10,11,12,13

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

Video Transcript | CDC Recommendations for Pneumococcal Disease in Adults Under Age 65 With Certain Chronic Conditions

Voice-Over:

This presentation has been created and paid for by Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc.

Dr. Hsu:

Hello and welcome to the “Time to…” Merck video series. I am Dr. Hsu and I’m an internal medicine, infectious diseases and preventive medicine physician at AdventHealth Medical Group in Orlando, Florida.  

In this segment, we will discuss the CDC recommendations for pneumococcal disease in adults under age 65 with certain chronic conditions.

Pneumococcal disease, caused by Streptococcus pneumoniae bacteria, has various manifestations, which can be grouped into noninvasive disease when confined to a mucosal location, or invasive disease, when the bacteria are detected in normally sterile sites such as the blood. Pneumococcal pneumonia can be noninvasive, for example, when isolated to the lungs, or invasive, such as pneumonia with bacteremia.

Following person-to-person transmission via respiratory droplets, the bacteria can remain within the nasopharynx, colonizing and causing no symptoms, or spread to other organs such as the lungs to cause bacteremic pneumococcal pneumonia.

Importantly, S. pneumoniae has the potential to cause other serious manifestations, such as pneumococcal bacteremia, by entering the bloodstream, or crossing the blood–brain barrier to cause pneumococcal meningitis.

In a retrospective cohort study, the risk for invasive pneumococcal disease, or IPD, increased with age, most notably in healthy adults ages 65 years and older. However, the average rate for IPD was approximately 3- to 7-fold higher in adults younger than age 65 years with diabetes, chronic heart disease, or chronic lung disease, such as COPD, respectively, than in age-matched healthy adults.

Adults with these conditions may have increased susceptibility to pneumococcal disease because of underlying factors related to their chronic condition. For example, in adults with diabetes, hyperglycemia causes functional impairment of certain immune cells, which results in reduced clearance of bacteria, such as S. pneumoniae, increasing the patient’s risk for infection.

In adults with chronic heart disease, the heart’s diminished capacity to pump blood causes lung congestion.

This accumulation of fluid in the lungs may reduce clearance of bacteria and increase the patient’s risk for infection.

And in adults with COPD, impaired activity of macrophages contributes to chronic inflammation and reduced clearance of bacteria, thus increasing the risk for infection.

Voice-Over:

Let’s discuss indications and Select Safety Information for PNEUMOVAX 23.

PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine.

PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged 2 years and older 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.

Now, let’s discuss some Select Safety Information for PNEUMOVAX 23, which you’ll hear more of throughout this video.

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.

Dr. Hsu:

Since 1997, the CDC has specifically recommended vaccination with PNEUMOVAX 23 at the time of diagnosis for appropriate adults under age 65 with diabetes, chronic heart disease, or COPD because of their increased risk for pneumococcal disease.

Therefore, for patients who have just been diagnosed with one of these conditions, pneumococcal vaccination should be considered as part of their routine medical care.

Other medical societies, such as the American Diabetes Association, the American College of Cardiology, and the Global Initiative for Chronic Obstructive Lung Disease, are consistent with the CDC’s recommendation of vaccination with PNEUMOVAX 23 for appropriate adults under age 65 with certain chronic conditions, such as diabetes, chronic heart disease, and COPD.

Voice-Over:

Here is some additional safety information for PNEUMOVAX 23.

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

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.

Dr. Hsu:

Additionally, a 2019 survey conducted by the National Foundation for Infectious Diseases including participants at increased risk for pneumococcal disease showed nearly half were unfamiliar with pneumococcal disease, and nearly 60% with an increased risk had never been advised to get vaccinated.

Voice-Over:

Let’s take a moment to review more safety information for PNEUMOVAX 23.

The most common adverse reactions, reported in more than 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.

Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.

Dr. Hsu:

As their health care professional, patients want to hear about pneumococcal vaccination from you. Therefore, it’s important that you review benefits and risks, and then provide a strong recommendation to your patients.

In addition, you may also want to consider communicating why you are recommending pneumococcal vaccination for your patient, such as why their condition puts them at increased risk. PNEUMOVAX 23 is the only pneumococcal vaccine recommended by the CDC for immunocompetent adults under age 65 with diabetes, chronic heart disease, and COPD and should be administered at the time of diagnosis.

The time to implement CDC guidance is now. It is important to help protect your appropriate adult patients against pneumococcal disease.

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.
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. Berical AC, Harris D, Dela Cruz CS, et al. Pneumococcal vaccination strategies. An update and perspective. Ann Am Thorac Soc. 2016;13(6):933-944. doi:10.1513/AnnalsATS.201511-778FR. Accessed August 5, 2020.
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.

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 for the first time in a clinical trial, 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.

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