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

CDC Recommendations for Pneumococcal Disease in Adults Under Age 65 With Certain 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’m 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 explore how to talk about pneumococcal disease with your adult patients under age 65 who have certain chronic conditions.

Many adult patients under age 65 may visit your office because of a chronic condition. The time to discuss preventive care can be limited; however, we can all make an impact by considering these 4 steps: Assess, Recommend, Administer or Refer, and Document to help ensure our patients are up-to-date with CDC recommended vaccines, including vaccination for pneumococcal disease. We’ll take a closer look at how we can carry out these steps.

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.

Dr. Hsu:

First, to help maximize the time with your patients, assess their vaccination status as a routine part of their office visit. For appropriate adults under age 65 years with diabetes, chronic heart disease, or chronic lung disease, such as COPD, the CDC recommends 1 dose of PNEUMOVAX 23 at the time of diagnosis.

Voice-Over:

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

Trained staff or an office Immunization Champion can also help minimize missed opportunities for vaccination, and maximize your time to discuss vaccination by assessing eligibility as part of a routine assessment at every office encounter. If an eligible patient with diabetes, chronic heart disease, or COPD did not receive PNEUMOVAX 23 at diagnosis per CDC recommendations, these routine assessments can determine if vaccination is appropriate.

Automatic reminders may also be useful. Standing orders and Best Practice Alerts, or BPAs, that can assist in identifying appropriate patients may be particularly effective in improving vaccination rates. For example, a retrospective study that evaluated the impact of pneumococcal-specific BPAs, in addition to updated workflow processes, showed that when implemented, PNEUMOVAX 23 vaccination rates improved by approximately 13% in eligible patients under age 65 with certain chronic conditions.

Resources on how to implement standing orders in your practice are readily available from organizations supported by the CDC, such as the Immunization Action Coalition. In addition, many electronic medical record systems have modules available for BPAs, which can be set up to provide prompts when a patient is due to receive vaccines.

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.

Dr. Hsu:

Patients look to you for guidance on their health care and vaccination is no exception. Adult patients with diabetes, chronic heart disease, or COPD may be most receptive to discuss vaccination as part of a healthy lifestyle, and can be encouraged to incorporate pneumococcal vaccination into their ongoing wellness program.

It is important to review benefits and risks and then provide a clear recommendation, such as: “Pneumococcal disease can be serious,” “the CDC recommends 1 dose of PNEUMOVAX 23 for adults your age and with your condition,” and “I strongly recommend that you get this vaccine.”

Remember, a provider recommendation for vaccination is crucial. One of the leading reasons why adults do not receive a vaccine is the lack of a recommendation from their provider.
In fact, your recommendation for vaccination is one of the most important interventions to improve patient acceptance of a vaccine.

Voice-Over:

Let’s again discuss some safety information for PNEUMOVAX 23. 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:

Highlighting your personal or professional experiences with vaccination may also help reinforce the importance of vaccination. The American College of Physicians also proposes that all physicians, including specialists, recommend vaccination for patients with chronic conditions to help prevent pneumococcal disease. This is important because many patients with chronic conditions, such as those with chronic heart disease, see their specialist as their main physician.

You may also consider tailoring your recommendation based on your patient’s condition and providing education on the interplay between their condition and increased risk of pneumococcal infection. For instance, patients with COPD may be interested to know that their condition contributes to chronic inflammation and reduced clearance of bacteria, thus increasing the risk for pneumococcal infection.

Patients with diabetes may also want to know that impaired glycemic control can put them at increased risk for pneumococcal infection. And patients with heart disease may want to know that the heart’s diminished capacity to pump blood causes lung congestion that can result in increased risk of pneumococcal infection.

It is also important to answer your patient’s questions in understandable language. For example, when discussing PNEUMOVAX 23, you may consider saying, “PNEUMOVAX 23 helps to protect against 23 types of pneumococcal bacteria that can cause pneumococcal disease.”

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:

Let’s recall that the CDC recommends vaccination with PNEUMOVAX 23 at the time of diagnosis for adult patients under age 65 with diabetes, chronic heart disease, or COPD. If your office does not stock or administer vaccines, referral to another vaccine provider, such as a pharmacist, may be helpful.

Pharmacy vaccination laws and regulations vary by state. Consult the appropriate resources, including the relevant state pharmacy board, for more information.

Finally, document the vaccines received by your patients to help your office, your patients, and other providers know which vaccines they have received. It is important to report it to your state’s immunization registry, consistent with applicable requirements.

The time to help protect your patients with diabetes, chronic heart disease, or COPD from pneumococcal disease is now, by maximizing our time to discuss and prioritize vaccination with PNEUMOVAX 23, the only pneumococcal vaccine recommended by the CDC for immunocompetent adults under age 65 with these conditions.

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, Possick JD. 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 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-01116 08/20