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: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2014;63(37):822–825.
2. 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.)
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. Prevnar 13 [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2017.
5. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1222858-0000.
6. 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.
7. 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.
8. American Diabetes Association. Standards of medical care in diabetes—2017. Diabetes Care. 2017;40(suppl 1):S25–S32.
9. 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.
10. 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.
11. Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Updated 2017. http://goldcopd.org/gold-2017-global-strategy-diagnosis-management-prevention-copd/. Accessed August 9, 2017.
12. Centers for Disease Control and Prevention (CDC). Noninfluenza vaccination coverage among adults - United States, 2011. MMWR Morb Mortal Wkly Rep. 2013;62(4):66–72.
13. Centers for Disease Control and Prevention (CDC). Vaccination coverage among adults in the United States, NHIS, 2015. cdc.gov/vaccines/imz-managers/coverage/adultvaxview/coverage-estimates/2015.html. Accessed August 18, 2017.
14. US Department of Health and Human Services. Healthy People 2020: Immunization and Infectious Diseases. healthypeople.gov/2020/topics-objectives/topic/immunization-and-infectious-diseases/objectives. Accessed August 18, 2017.
15. Butler JC, Breiman RF, Campbell JF, et al. Pneumococcal polysaccharide vaccine efficacy: an evaluation of current recommendations. JAMA. 1993;270(15):1826–1831.
16. Centers for Disease Control and Prevention (CDC). Pneumococcal disease: surveillance and reporting. cdc.gov/pneumococcal/surveillance.html. Updated June 21, 2016. Accessed August 24, 2017.
17. Pilishvili T, Ahmed S, Xing W, et al. Impact of 13-valent pneumococcal conjugate vaccine use in the US on invasive pneumococcal disease (IPD) among adults with chronic conditions. Poster #0638. Presented at: 10th International Symposium on Pneumococci and Pneumococcal Diseases; June 26–30, 2016; Glasgow, Scotland.
18. Centers for Medicare & Medicaid Services. Modifications to Medicare Part B coverage of pneumococcal vaccinations. http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM9051.pdf. Accessed August 24, 2017.
19. National Committee for Quality Assurance (NCQA). HEDIS® 2018 Measures. http://www.ncqa.org/hedis-quality-measurement/hedis-measures/hedis-2018. Accessed November 7, 2017.
20. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1163180-0002.
21. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1163180-0012.
22. Data available on request from Merck, Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package VACC-1163180-0005.

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.

Diabetes and Pneumococcal Vaccination: Missed Opportunities

Diabetes and the Increased Risk for Pneumococcal Disease

Sethu Reddy, MD, MBA—Senior Consultant, Cleveland Clinic, Former Chief of Adult Diabetes, Joslin Diabetes Center, and Former Vice President for Global Medical Affairs, Merck—explains preventing missed opportunities for vaccination in appropriate patients with diabetes mellitus, including:

  • The higher risk for invasive pneumococcal disease in patients with diabetes mellitus.7
  • Four different clinical scenarios where adults with diabetes meet with health care providers.
  • Recommendations for vaccinating appropriate adults under 65 years of age, with diabetes mellitus, with PNEUMOVAX 23 at time of diagnosis.6,8

Video Transcript | Diabetes and the Increased Risk for Pneumococcal Disease

Voice-Over:

This presentation has been created and paid for by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. The information in this presentation is intended for health care professionals in the United States, its territories, and Puerto Rico.

Dr. Reddy:

Hi, I’m Dr. Sethu Reddy, Senior Consultant at the Cleveland Clinic and former Chief of Adult Diabetes at the Joslin Diabetes Center.

We’re all aware that adults with diabetes mellitus are at increased risk for pneumococcal disease. For these patients, pneumococcal vaccination can help reduce the risk for pneumococcal disease caused by serotypes contained in the vaccine.

Yet, published data show that adults with diabetes who are younger than 65 years of age have approximately 3 times the risk for invasive pneumococcal disease, or IPD, compared to healthy, age-matched counterparts.

Today, we’ll explore 4 different clinical scenarios in which adults with diabetes who are younger than 65 meet with health care providers.

Despite being at a higher risk for pneumococcal disease the opportunity to identify and vaccinate with PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent) is often missed.

Better communication with adult patients with diabetes to improve pneumococcal vaccination could greatly help this high-risk population.

Voice-Over:

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.

Dr. Reddy:

Let’s follow a young adult patient recently diagnosed with diabetes through some of his interactions with his health care providers.

Michael is 45 years old and is a high school teacher. Here he is entering his doctor’s office.

Voice-Over:

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.

Primary care physician:

As a primary care provider, that was my moment to assess my adult patient, including his pneumococcal vaccination history, and, if appropriate, administer PNEUMOVAX 23.

According to 2015 CDC data, the serotypes in PNEUMOVAX 23 accounted for approximately 63% of all IPD cases in adults 19 through 64 years of age.

Voice-Over:

These are CDC epidemiologic data that do not reflect the efficacy of PNEUMOVAX 23.

Primary care physician:

Keep in mind, the CDC specifically recommends PNEUMOVAX 23 for appropriate adults under 65 years of age with diabetes mellitus.

Multiple professional organizations, including the American Diabetes Association (ADA), are consistent with the CDC’s recommendation of pneumococcal vaccination for appropriate adults with certain chronic conditions.

But despite the CDC and ADA recommendations, I’ve been so focused on Michael’s diabetes since I diagnosed him that I haven’t thought about his increased risk for pneumococcal disease. I missed my opportunity to vaccinate.

Dr. Reddy:

Here is Michael with his diabetes educator, whom he’ll see several times this year, after diagnosis. She will help facilitate Michael’s education and management of diabetes mellitus—showing him how to take daily medications, check blood sugar levels, and adapt his diet and exercise habits.

Voice-Over:

PNEUMOVAX 23 should be given to a pregnant woman only if clearly needed.

Diabetes educator:

As a diabetes educator, that was my moment to assess Michael’s pneumococcal vaccination status, or history. If appropriate, I could have referred him for vaccination or provided him with direction so he could be vaccinated in a timely manner.

Unfortunately, according to a 2015 national practice survey by the American Association of Diabetes Educators, only about 20% of diabetes educators offer information or discuss vaccinations with people who have diabetes. Although I’ll see Michael multiple times this year, I have yet to discuss vaccination against pneumococcal disease with him.

Dr. Reddy:

A few months later, we follow Michael to the hospital, where he’s almost fully recovered from a minor orthopedic procedure.

Voice-Over:

Caution should be exercised when PNEUMOVAX 23 is administered to a nursing woman.

Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.

Nurse:

We’ve taken care to get Michael healthy. He’s on the mend, and soon he’ll be ready for discharge. This was my moment to identify Michael’s pneumococcal vaccination status or history, and, if appropriate, vaccinate him with PNEUMOVAX 23.

Dr. Reddy:

The last place Michael will visit is the pharmacy, where he regularly fills his prescriptions.

Voice-Over:

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.

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

Pharmacist:

As Michael’s pharmacist, I’m in a perfect position to assess his pneumococcal vaccination status or history. I see him regularly because of the prescriptions he gets filled at least once a month.

Knowing this, I should have spoken with Michael to determine whether it’s appropriate to vaccinate him with PNEUMOVAX 23. That was my moment.

Dr. Reddy:

Despite repeated opportunities, Michael and many adults younger than 65 with diabetes mellitus remain unvaccinated and at increased risk for pneumococcal disease.

A study conducted between 2007 and 2010 showed that within 3 years of diagnosis, about 1 out of every 10 patients aged 19 to 64 years with diabetes mellitus had been vaccinated against pneumococcal disease.

It’s our duty as health care providers to watch out for Michael and other adult patients under age 65 with diabetes. As we said, the CDC recommends pneumococcal vaccination with 1 dose of PNEUMOVAX 23 for appropriate adults with certain chronic conditions, including diabetes mellitus, chronic heart disease, and chronic lung disease (COPD), at the time of diagnosis. This is your moment to help protect them from pneumococcal disease.

Voice-Over:

Before administering PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent), please read the accompanying Prescribing Information. The Patient Information also is available.

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.

CDC=Centers for Disease Control and Prevention.
VACC-1101056-0024 05/18