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The Pneumococcal Vaccine in Diabetes
Annah J. Brittingham, Pharm.D. Candidate, Ruthanne S. Staas, Pharm.D. Candidate, Yen Dang, PharmD, CTTS-M
University of Maryland Eastern Shore School of Pharmacy and Health Professions
11868 College Backbone Road, Princess Anne, Maryland 21853
Introduction
Streptococcus pneumoniae is a bacteria commonly associated with ear or sinus infections, meningitis, bacteremia, or pneumonia. Pneumococcal disease can be diagnosed through testing blood or cerebrospinal fluid. The most common symptoms include fever, chills, difficulty breathing, confusion, and pain. Complications of this disease can result in permanent damage or death. Individuals with chronic illness, particularly patients with diabetes are at a higher risk of pneumococcal disease.1
Centers for Disease Control and Prevention (CDC) Recommendations
CDC recommends a single dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) for patients with diabetes and no other comorbid condition between 19 and 64 years of age. At 65 years, patients with diabetes should get a 13-valent pneumococcal vaccine (PCV13) followed by
a dose of PPSV23 one year afterwards.1 It is recommended that there be a 1-year interval between PPSV23 and PCV13, and a 5-year interval between two doses of PPSV23. Neither the PPSV23 nor PCV13 are recommended for women with gestational diabetes without other risk
factors.2
Healthy People 2020
Healthy People 2020 is a federal government prevention agenda that have set goals for pneumococcal vaccinations. These goals were focused on reducing the number of pneumococcal infections to 31 cases per 100,000 adults aged 65 years and older.3 According to the National Health Interview Survey in the United States in 2017, 69% of individuals in this population had received a pneumococcal vaccination. This falls short of their vaccination goal of 90% of people
aged 65 years and older to be vaccinated.4,5 PCV13 and PPSV23 Prevnar 13 is indicated at age 6 weeks and older for the prevention of pneumonia and invasive
disease caused by s. pneumoniae. There are 13 serotypes contained in the vaccine: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. Contraindications include a severe allergic reaction to any component of PCV13 or diphtheria toxoid-containing vaccine. The most common adverse events reported in clinical trials include pain at the injection site (>50%), fatigue (>30%),headache (>20%), muscle pain (>20%), joint pain (>10%), decreased appetite (>10%), injection site erythema (>10%), injection site swelling (>10%), limitation of arm movement (>10%).5 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. There are 23 serotypes contained in the vaccine: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F,
23F, and 33F. Contraindications to this vaccine include a severe allergic reaction to any component of PPSV23. The most common adverse events reported in clinical trials include pain and soreness at the injection site (60%), injection site swelling (20.3%), headache (17.6%), injection site erythema (16.4%), asthenia and fatigue (13.2%), and myalgia (11.9%).5
Clinical Implications
Healthcare providers play a vital role in advancing the Healthy People 2020 goals in patients with diabetes. This includes but is not limited to educating patients on the benefits and risks of pneumococcal vaccines, vaccine administration, vaccine scheduling, handling and storing vaccinations properly, management of side effects, screening for precautions and contraindications, and reporting side effects to the national vaccine safety monitoring program. If a patient cannot recall their past pneumococcal vaccination, providers should refer to their state vaccination registries. For example, ImmuNet Maryland is a confidential and secure database that stores an individual’s vaccination records. It also serves as a site for healthcare providers to verify if patients are vaccinated on time and confirm if they are not under or over vaccinated.6 In the event of a severe allergic reaction, report the event to the Vaccine Adverse Event Reporting System (VAERS) or by calling 1-800-822-7967.7
Literature Review of Pneumococcal Vaccine in Patients with Diabetes
The CAPITA trial was a randomized, double-blind, placebo-controlled trial that enrolled 84,496 participants to evaluate the prevention of vaccine-type community-acquired pneumonia (VTCAP) in adults 65 years of age or older. Patients were randomized to receive PCV13 versus placebo.9 Results showed that 49 patients in the PCV13 group and 90 patients in the placebo group had a confirmed VT-CAP at the end of the study period ([95% CI, 21.8-62.5]; P<0.001).9 This study did not report outcomes in patients with diabetes. However, in a post-hoc analysis of the CAPITA trial, 139 subjects with diabetes who developed VT-CAP had lower pneumococcal complications (p-value = 0.002) with a vaccine efficacy rate of 89.5% [95% CI, 65.5-96.8].9 A population-based retrospective cohort study by Kuo et al.10 evaluated the benefit of PPSV23 in patients with diabetes over the age of 75 years. This trial showed that patients who were vaccinated had less invasive pneumococcal diseases (IPDs) than the patients who had not
received the vaccine (OR=0.80, 95% CI, 0.74-0.87).10
Conclusion
Patients with diabetes are more susceptible to infection by pneumococcal disease and should be vaccinated against the bacteria to reduce the rates of vaccine-preventable deaths. Other vaccinations that are pertinent in patients with diabetes include influenza, hepatitis B, Tdap with Td booster every 10 years, and zoster vaccine.1,4
References
1. Center for Disease Control and Prevention. Pneumococcal Disease. https://www.cdc.gov/pneumococcal/vaccination.html. Accessed October 14, 2019.
2. Immunization Action Coalition. Ask the Experts: Pneumococcal Vaccines (PCV13 and PPSV23). https://www.immunize.org/askexperts/experts_pneumococcal_vaccines.asp.
Accessed November 2, 2019.
3. Pharmacy Times. Healthy People 2020: Immunization Goals. https://www.pharmacytimes.com/publications/supplements/2019/august2019/healthypeople-
2020-immunization-goal. Accessed October 14, 2019
4. Center for Disease Control and Prevention. Vaccination Coverage Among Adults in the United States, National Health Interview Survey, 2016.
https://www.cdc.gov/vaccines/imz-managers/coverage/adultvaxview/pubsresources/ NHIS-2016.html. Accessed October 14, 2019.
5. Center for Disease Control and Prevention. Early Release of Selected Estimates Based on Data From the 2017 National Health Interview Survey;
https://www.cdc.gov/nchs/nhis/releases/released201806.htm. Accessed October 18, 2018.
6. Maryland Department of Health. About ImmuNet. https://phpa.health.maryland.gov/OIDEOR/IMMUN/Pages/faq-immunet.aspx. Accessed
October 30, 2019.
7. Food and Drug Administration. Vaccine Adverse Event Reporting System (VAERS). https://vaers.hhs.gov/. Accessed October 16, 2019.
8. Center for Disease Control and Prevention. Administering Pneumococcal Vaccine. https://www.cdc.gov/vaccines/vpd/pneumo/hcp/administering-vaccine.html. Accessed
October 14, 2019.
9. Marc J.M. Bonten, M.D., Ph.D., Susanne M. Huijts, M.D., et al. Polysaccharide Conjugate Vaccine against Pneumococcal Pneumonia in Adults. The New England
Journal of Medicine. 2015; 372:1114-1125.
10. Kuo, C.-S., Lu, C.-W., Chang, et al. Effectiveness of 23-valent pneumococcal polysaccharide vaccine on diabetic elderly. Medicine. 2016;6:42-50.
https://www.ncbi.nlm.nih.gov/pubmed/27368047. Accessed October 15, 2019.