1. Narrowing the Gap in Vaccine Coverage Among Adults

2. Educational Learning Objectives At the conclusion of this presentation, the participant should be able to: Indicate the recommendations for current vaccines and vaccine schedules for adults Indicate the current burden of vaccine-preventable diseases among adults Identify profiles of specific patients at greatest risk for these vaccine-preventable diseases Implement strategies for improving immunization rates within one’s clinical practice, taking into account current immunization schedules and guidelines Address immunization barriers frequently encountered during patient/caregiver communications regarding safety, efficacy, and possible misinformation

3. Vaccine-Preventable Diseases in Adults Diphtheria Hepatitis A Hepatitis B Herpes zoster Human papillomavirus Influenza Measles Meningococcal disease Mumps Pertussis Pneumococcal disease Rubella Tetanus Varicella

4. Influenza IAC. http://www.immunize.org/photos/flu-photos.asp. Accessed March 2012. Source: National Museum of Health and Medicine, Armed Forces Institute of Pathology, Washington, DC, Image NCP 1603. Emergency hospital during 1918 influenza epidemic, Camp Funston, Kansas

5. VariableEstimated Annual Impact Cases24.7 million Outpatient visits31.4 million Hospitalizations334,185 Hospitalized days3.1 million Days of productivity lost due to illness44.0 million Deaths41,008 Life years lost610,656 Medical costs$10.4 billion Lost earnings due to illness and loss of life$16.3 billion Total economic burden$87.1 billion Seasonal Influenza Has a Huge Annual Impact in the United States Molinari NA, et al. Vaccine. 2007;25:5086-5096. Based on 2003 US population demographics Reminder: Huge variability in the number of influenza cases each year

6. Influenza in the Elderly Serious complications from influenza –Secondary infections –Exacerbations of chronic diseases –Increased hospitalization and death Influenza vaccination –Reduced Hospitalizations and death CDC. MMWR Recomm Rep. 2010;59(33):1057-1062.

7. Annual Influenza Vaccine Is Recommended for All adults without contraindications High-risk groups when supplies are limited in a non-epidemic year include: –Adults > 50 years –Young children –Pregnant women –People with chronic comorbidities Under epidemic conditions with short vaccine supply, the primary groups for vaccination may change CDC. MMWR Recomm Rep. 2010;59(RR8):1-62.

8. Seasonal Influenza Vaccines FactorLAIVTIV Route of administrationIntranasal spray Intramuscular, intradermal injection Type of vaccine Live attenuated, cold adapted virus Killed virus Number of included virus strains 3* (2 influenza A, 1 influenza B) 3 (2 influenza A, 1 influenza B) Vaccine virus strains updatedAnnually Frequency of administrationAnnually Approved age2–49 yrs≥ 6 mos** OK for persons with medical risk factors for influenza- related complications † NoYes CDC. MMWR Morb Mortal Wkly Rep. 2010;59(RR8):1-62. TIV: trivalent inactivated influenza vaccine LAIV: live, attenuated influenza vaccine *Quadrivalent (2 influenza A, 2 influenza B) FDA-approved; available Fall 2013 **High-dose, IM TIV approved for ≥ 65 yrs † Includes medical conditions such as chronic pulmonary, cardiovascular, renal, hepatic, neurologic, hematologic or metabolic disorders; those who are immunosuppressed; those who are or will be pregnant during influenza season; residents of nursing homes and chronic-care facilities

9. Influenza Vaccination Coverage 2010–2011 Influenza Season CDC. MMWR Wkly Rep. 2011;60(32):1074-1077. CDC. MMWR Wkly Rep. 2011;60(32):1078-1082. CDC. http://www.cdc.gov/flu/professionals/vaccination/coverage_1011estimates.htm. Accessed Mar 2012. HP: Healthy People 90%

10. Place of Influenza Vaccination Among Adults 2010–2011 Influenza Season CDC. MMWR Wkly Rep. 2011;60(23):781-785.

11. 2012–2013 Influenza Season 2012-2013 Trivalent Influenza Vaccines –A/California/7/2009(H1N1)–like virus –A/Victoria/361/2011 (H3N2)–like virus –B/Wisconsin/1/2010–like virus Current flu information –CDC: http://www.cdc.gov/flu/ –Licensed Influenza Vaccines: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ ucm094045.htm FDA. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccines andOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM296193.pdf. Accessed March 2012.

12. 2012–2013 Influenza Season VaccineTrade NameAge Group Route of Administration TIVFluzone; sanofi All Adults Intramuscular TIVFluvirin; NovartisIntramuscular TIVFluarix; GSKIntramuscular TIVFluLaval; GSKIntramuscular TIVAfluria; CSLIntramuscular TIVFluzone High-Dose*; sanofi ≥ 65 years Intramuscular TIVFluzone Intradermal; sanofi 18–64 yearsIntradermal LAIV*FluMist; MedImmune 2–49 yearsIntranasal TIV: trivalent inactivated influenza vaccine; LAIV: live attenuated influenza vaccine *Each 0.5 mL dose contains 60 μg each of the 3 influenza strain antigens *Quadrivalent LAIV (2 influenza A, 2 influenza B) FDA-approved; available Fall 2013 CDC. MMWR Wkly Rep. 2011;60(33):1128-1132.

13. Intradermal TIV Influenza Vaccine FDA. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts /UCM195479.pdf. Accessed March 2012. Kris E, et al. Vaccine. 2012;30(3):523-538.

14. Importance of Influenza Vaccination for Pregnant Women Women in the 2 nd and 3 rd trimester are at increased risk for serious medical complications and hospitalization from influenza –Alterations in the immune, respiratory, and cardiovascular systems during pregnancy Vaccination protects: –The woman –The fetus –The newborn child CDC. MMWR Recomm Rep. 2010;59(RR-8):1-62.

15. Maternal Influenza Immunization and Protection of Infants Eick A, et al. Arch Pediatr Adolesc Med. 2011;165:104-111. Nonrandomized, prospective, observational cohort study Navajo and White Mountain Apache Indian Reservations N = 1160 mother infant pairs; birth–6 months Infants Born to Vaccinated Mothers vs Unvaccinated Mothers 41% ↓ in risk of laboratory confirmed influenza virus infection RR: 0.59; 95% CI, 0.37–0.93 39% ↓ in risk of influenza-like illness hospitalization RR: 0.61; 95% CI, 0.45–0.84 Higher hemagglutinin inhibition antibody titers at birth and 2–3 months

16. Poehling K, et al. Am J Obstet Gynecol. 2011;204(6 Suppl 1):S141-148. Impact of Maternal Immunization on Influenza Hospitalizations in Infants < 6 Months 7 influenza seasons, 2002–2009; 3 diverse geographical areas in the US 1510 hospitalized infants < 6 months old Infants of vaccinated mothers were 45–48% less likely to have influenza hospitalization vs infants of unvaccinated mothers Infant Influenza Positive Number of Infants Total N = 1510 Moms Vaccinated n = 294 Moms Not Vaccinated n = 1216 No1359276 (20%)1083 (80%) Yes15118 (12%)133 (88%)

17. Influenza Vaccination Coverage Levels Health Care Personnel CDC. MMWR Wkly Rep. 2011;60(32):1073-1077. CDC. MMWR Recomm Rep. 2010;59(RR8):1-62. CDC. MMWR Wkly Rep. 2010;59(12):357-362.

18. Health Care Personnel Survey, 2010–2011 Belief Vaccinated (n = 1,334) Agree/strongly agree (%) Not Vaccinated (n = 586) Agree/strongly agree (%) I am at risk for getting influenza 85.660.6 People around me are at risk for getting influenza 91.871.1 Influenza is a serious threat to my health 70.134.2 Influenza is a serious threat to the health of the people around me 88.959.9 Influenza vaccination can protect me from getting influenza 92.754.2 If I get an influenza vaccination, people around me will be better protected from influenza 89.144.6 Influenza vaccination is safe 94.866.2 Getting vaccinated for influenza is worth the time and expense 94.745.8 CDC. MMWR Wkly Rep. 2011;60(32):1073-1077.

19. Influenza Vaccination of Health Care Workers: Employer Mandates Babcock HM, et al. Clin Infect Dis. 2010;50:459-464. 2008: Mandatory influenza vaccination On quality scorecard; Declination statements Vaccine shortage N = 25,980 employees, Midwestern health care organization Employment Terminated

20. Position Statements Endorsing Mandatory Influenza Vaccination for Health Care Workers AAFP: American Academy of Family Physicians AAP: American Academy of Pediatrics ACP: American College of Physicians AHA: American Hospital Association AMDA: American Medical Directors Association APhA: American Pharmacists Association APHA: American Public Health Association APIC: Association for Professionals in Infection Control and Epidemiology IDSA: Infectious Diseases Society of America NFID: National Foundation for Infectious Diseases NPSF: National Patient Safety Foundation SHEA: Society for Healthcare Epidemiology of America IAC. http://www.immunize.org/honor-roll/. Accessed March 2012.

21. Reminder: when you think about influenza vaccine for your patients, think about pneumococcal vaccine as well …

22. Pneumococcal Disease Major pneumococcal clinical syndromes include –Pneumonia –Bacteremia –Meningitis → → → → Invasive pneumococcal disease (IPD): isolation of S. pneumoniae from a normally sterile site (blood, CSF, pleural, pericardial, peritoneal, bone or joint fluid) Pneumococcal diseases encompass invasive and non-invasive syndromes Adapted from CDC. http://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html. Accessed March 2012.

23. Risk Factors for Pneumococcal Disease Extremes of age Comorbidities; including diabetes, asthma, COPD, emphysema, chronic liver disease, cirrhosis, chronic heart disease, chronic renal disease Certain ethnic groups Cerebrospinal fluid leaks Immunocompromising conditions Asplenia (functional and anatomic) Smoking CDC. http://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html. Accessed March 2012.

24. Changes in Overall Invasive Pneumococcal Disease, 1998–2007 Pilishvili T, et al. J Infect Dis. 2010;201:32-41. Cases/100,000 Population 0 20 40 60 100 80 120 1998199920012000200220032004200520062007 Year PCV7 introduced Age Group 2007 vs baseline* (years) (% reduction) < 5 5–17 18–49 50–64 ≥ 65 76 43 40 18 37 *Baseline is 1998-1999

25. Invasive Pneumococcal Disease Among Adults ≥ 65 Years, 1998–2007 Pilishvili T, et al. J Infect Dis. 2010;201:32-41. Cases/100,000 Population 0 5 10 15 20 25 30 35 40 1998199920012000200220032004200520062007 Year PCV7 introduced Serotype group PCV7 type Non-PCV7 type 19A Included in PCV13

26. S. Pneumoniae ABCs Data USA: 2010 Invasive Pneumococcal Disease (Inpatient and Outpatient) CDC ABC Surveillance report. http://www.cdc.gov/abcs/reports-findings/survreports/spneu10- orig.pdf. Accessed March 2012.

27. S. Pneumoniae ABCs Data–2010 IPD in All Age Groups Meningitis 6% Bacteremia without Focus 17.9% Pneumonia with Bacteremia 69.3% Not Categorized 6.8% Based on a total of 3,826 IPD cases CDC ABC Surveillance report. http://www.cdc.gov/abcs/reports-findings/survreports/spneu10- orig.pdf. Accessed March 2012.

28. Burden of Pneumococcal Disease in Older Adults (≥ 50 yrs) Weycker D, et al. Vaccine. 2010;28:4955-4960. IPD: invasive pneumococcal disease; NPP: nonbacteremic pneumococcal pneumonia

29. Economic Burden of Pneumococcal Disease in Older Adults (≥ 50 yrs) Weycker D, et al. Vaccine. 2010;28:4955-4960. IPD: invasive pneumococcal disease; NPP: nonbacteremic pneumococcal pneumonia $3.7 billion in total direct costs $1.8 billion in total indirect costs

30. Pneumococcal Polysaccharide Vaccine (PPSV23) for Adults Vaccine contains 23 polysaccharide serotypes from S. pneumoniae Single dose recommended for: –All ≥ 65 years –Asthmatics and smokers age 19 to 64 years –19 to 64 years: chronic cardiovascular disease, chronic lung disease, diabetes, alcoholism, chronic liver disease, CSF leaks, asplenia, cochlear implants –Immunocompromised persons CDC. MMWR Morb Mortal Wkly Rep. 2010;59(34):1102-1106.

31. Cigarette Smoking and Risk of Invasive Pneumococcal Disease Nuorti JP, et al. N Engl J Med. 2000;342:681-689. Number of Cigarettes SmokedNonsmoker Exposure to Tobacco Smoke

32. Revaccination with PPSV23 19 to 64 years: one-time revaccination after 5 years –Functional or anatomic asplenia –Chronic renal failure or nephrotic syndrome –Persons with immunocompromising conditions ≥ 65 years: one-time revaccination if vaccinated ≥ 5 years previously and < 65 years at time of primary vaccination Those who receive PPSV23 at or after age 65 should receive only a single dose CDC. MMWR Morb Mortal Wkly Rep. 2010;59(34):1102-1106.

33. Pneumococcal Vaccination Coverage 2010 National Health Interview Survey CDC. MMWR Wkly Rep. 2012;61(4):66-72. HP: Healthy People

34. Effectiveness of PPSV23 in Adults 2008 Meta-analysis Results from 15 RCTs (N = 48,656) –Invasive pneumococcal disease (IPD)  Strong evidence of protection (74%)  OR 0.26 (95% CI 0.15–0.46); P < 0.00001 –All-cause pneumonia  Inconclusive efficacy (29%) [Substantial statistical heterogeneity]  OR 0.71 (95% CI 0.52–0.97); P = 0.029 –All-cause mortality  No evidence of protection (other factors may contribute)  OR 0.87 (95% CI 0.69–1.10); P = 0.25 –Adults with chronic illness  Evidence is less clear Moberley S, et al. Cochrane Database Syst Rev. 2008;(1):CD000422.

35. PPSV23 and Prevention of Pneumonia in Elderly Patients Cohort studies suggest protection against IPD Some cohort studies suggest protection against pneumonia, while others do not No randomized trials have demonstrated efficacy against pneumonia in the elderly

36. 13-Valent Pneumococcal Conjugate Vaccine (PCV13) Serotypes in PCV13 –1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F Licensed by FDA in February 2010 for use in children (6 weeks through 5 years) FDA approval for use in adults ≥ 50 years January 2012 FDA-approved indication in adults –Prevention of pneumonia and invasive disease caused by PCV13 S. pneumoniae serotypes ACIP recommendations for adults pending (waiting for more data) FDA. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/Approved Products/UCM201669.pdf. Accessed March 2012.

37. PCV13 in Adults ≥ 50 Years: Cost Effectiveness Analysis Results* Smith KJ, et al. JAMA. 2012;307:804-812. Cost Effectiveness (QALY) ICER (per QALY) Base case 65 and HR younger (PCV13) $1,08012.5846$28,900 PCV13 at 50 65 $1,12312.5856$45,100 PCV13 at 50 65, PPSV23 at 75 $1,13112.5856$496,000 Worst case PCV13 effectiveness † 65 and HR younger (PPSV23)$1,05912.5838$34,600 65 and HR younger (PCV13)$1,09212.5841$131,000 PCV13 at 50 65$1,15012.5843$255,000 PCV13 at 50 65, PPSV23 at 75$1,15812.5843$497,000 *Non-dominated strategies, per person † PCV13 effectiveness set at low range estimates against nonbacteremic pneumonia QALY: quality-adjusted life-years; ICER: incremental cost-effectiveness ratio

38. Estimates for Vaccination Strategies PCV13 and PPSV23 for Adults ≥ 50 Years Adapted from Smith KJ, et al. JAMA. 2012;307:804-812. 0 2,000 4,000 6,000 8,000 10,000 12,000 14,000 16,000 ≤ 65 yrs with HR (PPSV23) PCV13 @ 50 yrs PPSV23 @ 65 yrs ≤ 65 yrs with HR (PCV13) PCV13 @ 50 and 65 yrs PCV13 @ 50 and 65 yrs PPSV23 @ 75 yrs Cases Prevented NPP Base Case IPD Base Case NPP Worst Case † IPD Worst Case IPD: invasive pneumococcal disease NPP: hospitalized nonbacteremic pneumococcal pneumonia HR: high risk conditions † PCV13 effectiveness set at low range estimates against nonbacteremic pneumonia

39. CAPITA Trial: Does PCV13 Protect Adults From Pneumococcal Pneumonia? Hak E, et al. Netherlands J Med. 2008;66(9):378-383. NCT00744263. http://www.clinicaltrials.gov/ct2/show/NCT00744263. Accessed March 2012. Randomized, placebo-controlled clinical trial 85,000 adults ≥ 65 years – No prior vaccination with pneumococcal vaccine Primary/Secondary endpoints: –Cases of 1 st episode vaccine-serotype specific pneumococcal community-acquired pneumonia –Cases of vaccine-serotype invasive pneumococcal disease, safety Results expected 2013

40. PCV13 in Adults – Additional Considerations ACIP has not issued recommendations June 2012 ACIP policy meeting will discuss use in adults with immunocompromising conditions Policy Question: how will routine PCV13 in children impact use (and need) in adults? –Ongoing monitoring of IPD cases via Active Bacterial Core Surveillance (ABCs) –Herd effects from children may reduce benefit of PCV in adults Policy Question: efficacy against pneumonia unknown; waiting for CAPITA trial Sequence of PCV13 and PPSV23

41. Pertussis Pertussis is still around –Year to year natural variation in pertussis epidemiology –27,550 cases reported in the US in 2010 –In California, 2010  9,143 cases, including 10 infant deaths  Most cases reported in 63 years Infants who are too young to be vaccinated bear the burden of severe disease Most pertussis-related deaths occur in infants < 4 months of age Adolescents and adults play a significant role in transmission of pertussis CDC. http://www.cdc.gov/pertussis/about/index.html. Accessed March 2012. The Joint Commission. http://www.jointcommission.org/assets/1/6/Tdap_Monograpgh.pdf. Accessed March 2012.

42. Reported Pertussis Incidence by Age Group 1990–2010 CDC Pertussis Surveillance. http://www.cdc.gov/pertussis/surv-reporting.html. Accessed March 2012. 100 80 60 40 20 0 Incidence (per 100,000) 1990 2005201020001995 < 1 yr 1–6 yrs 7–10 yrs 11–19 yrs 20+ yrs

43. Household members responsible for 75–83%: –Parents and siblings were commonly suspected sources  Parents (55%)  Siblings (16–20%) –Aunts/uncles (10%) –Friends/cousins/others (10–24%) –Grandparents (6%) –Caretakers (2%) Medical personnel may contribute to some cases of pertussis Source of Pertussis Transmitted to Infants ≤ 6 Months Old Wendelboe AM, et al. Pediatr Infect Dis J. 2007;26:293-299. Bisgard KM, et al. Pediatr Infect Dis J. 2004;23(11):985-989.

44. Updated Recommendations– Tdap for Adults Single Tdap dose for adults ≥19 years who have not previously received Tdap Tdap vaccines  Adacel ®  Boostrix ® Tdap can be administered regardless of interval since last Td vaccine CDC. MMWR Wkly Rep. 2011;60(41):1424-1426. CDC. MMWR Wkly Rep. 2012;61(4):1-7.

45. Tdap and Pregnancy Maternal vaccination –Tdap during pregnancy, 3 rd or late 2 nd trimester (after 20 weeks’ gestation) –No safety signals of concern from VAERS, manufacturer’s pregnancy registry Cocooning strategy –Recommended by ACIP since 2005 –Limited success due to failure of maternity hospitals to vaccinate fathers, other family members –Providers should be sure to vaccinate family members who will be caring for newborns Current recommendation for adolescents and adults who have or anticipate close contact with an infant < 12 months –Single dose of Tdap (ideally 2 weeks prior to close infant contact) CDC. MMWR Wkly Rep. 2011;60(41):1424-1426.

46. Tetanus Vaccination Coverage 2010 National Health Interview Survey CDC. MMWR Wkly Rep. 2012;61(4):66-72. Tetanus vaccination, past 10 years Tetanus vaccination, including pertussis, past 5 years The rate of incident tetanus is very low

47. Human Papillomavirus CDC. MMWR Wkly Rep. 2010;59(20):626-632. CDC. MMWR Wkly Rep. 2011;60(50):1705-1708. NCI. http://www.cancer.gov/cancertopics/factsheet/Risk/HPV. Accessed March 2012. Electron micrograph of human papillomavirus (HPV). Courtesy of NCI. 1986. HPV-associated cancers in the US – Cervical, vulvar, vaginal, anal, penile, and oropharyngeal cancer – > 20,000 per year in women (majority cervical cancer) – > 11,000 per year in men (majority oropharyngeal cancers) HPV 16 and 18 cause ~70% of cervical cancers HPV 16 causes 80–90% of anal cancers and a significant percentage of oral cancers HPV 6 and 11 cause ~90% genital warts and most cases of recurrent respiratory papillomatosis

48. Available HPV Vaccines Quadrivalent Merck - Gardasil ® Bivalent GSK - Cervarix ® Licensed in the US 20062009 Virus-like Particle Types HPV 6, 11, 16, 18HPV 16, 18 Hypersensitivity- related contraindication YeastLatex Licensed age range9–26 yrs*9–25 yrs ACIP Recommendations Routine 11–12 yrs ♀ and ♂ Catch-up 13–26 yrs Routine 11–12 yrs ♀ Catch-up 13–26 yrs Schedule 0, 2, 6 months0, 1, 6 months CDC. MMWR Wkly Rep. 2010;59(20):626-632. *Licensed for use in females and males

49. HPV–Recommendations for Females Quadrivalent HPV (HPV4) and Bivalent HPV (HPV2) Routine vaccination of females age 11 to 12 years –Catch-up 13-26 years ACIP: no preference for either vaccine HPV4 or HPV2 vaccination for prevention of HPV 16/18- related cervical cancers, pre-cancers, and dysplastic lesions Vaccination with HPV4 for additional prevention against genital warts, pre-invasive and invasive lesions of the vagina and vulva CDC. MMWR Wkly Rep. 2010;59(20):626-629.

50. HPV–Recommendations for Males Routine vaccination of males 11–12 years with HPV4, 3-dose series Series can be started at 9 years Catch-up for males 13–21 years who have not been vaccinated or have not completed the 3-dose series All doses count, so no need to restart the series if there is a departure from the schedule Males 22–26 years may be vaccinated Immunocompromised males, vaccinate through age 26 years CDC. MMWR Wkly Rep. 2011;60(50):1705-1708.

51. Lifetime Cancer Cases Averted by Vaccinating 1 Million Males in a Birth Cohort: HPV ACIP. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-oct11/05-HPV-Dunne.pdf. Accessed March 2012.

52. Human Papillomavirus Vaccination Coverage 2010 National Health Interview Survey CDC. MMWR Wkly Rep. 2012;61(4):66-72.

53. Varicella Zoster Varicella zoster virus dormant in sensory ganglia can reactivate and cause herpes zoster 1 million people develop zoster in the US each year Lifetime risk 30% Half of all cases occur in those ≥ 60 years Zoster more common in those with altered immunocompetence Common complication of zoster is postherpetic neuralgia (PHN) CDC. MMWR Recomm Rep. 2008;57(RR-5):1-30.

54. Herpes Zoster Vaccine Zostavax ® live, attenuated vaccine –Single dose, subcutaneous injection –Contraindications include pregnancy*, primary or acquired immunodeficiency, history of anaphylactic reaction to vaccine components In 2011, FDA approved for use ≥ 50 years ACIP recommendation remains ≥ 60 years (greater benefit later in life, however earlier vaccination for some high risk groups may have value) CDC. MMWR Wkly Rep. 2011;60(44):1528. *Women who wish to have the vaccine at age 50 may need to consider a pregnancy evaluation

55. Herpes Zoster Vaccination Coverage 2010 National Health Interview Survey CDC. MMWR Wkly Rep. 2012;61(4):66-72. HP: Healthy People

56. Hepatitis B (HBV) 3,374 cases of acute Hepatitis B in the United States were reported to CDC (2009) –Actual number estimated to be 10x higher –Highest rates among males 25–44 years (high- risk behaviors) 800,000 to 1.4 million in the US have chronic HBV –Majority are asymptomatic 15 to 25% of chronically infected persons will die from cirrhosis, liver failure, or hepatocellular carcinoma 2,000–4,000 chronic HBV-related deaths annually CDC. http://www.cdc.gov/hepatitis/HBV/index.htm. Accessed March 2012.

57. Adult Populations with Indications for HBV Vaccination Household contacts/sex partners of individuals with chronic HBV Injection drug users Men who have sex with men Sexually active people, multiple partners HIV infected People seeking STD evaluation/treatment Hemodialysis patients; those with renal disease that may result in dialysis Diabetics Health care personnel who are exposed to blood Clients and staff of institutions for the developmentally disabled People with chronic liver disease Inmates of long-term correctional facilities Certain international travelers CDC. MMWR Wkly Rep. 2012;61(4):1-7.

58. Risk for Hepatitis B in Adults with Diabetes Analysis of 8 Emerging Infections Program sites, 2009– 2010 –Persons 23–59 years (without HBV risk behaviors) 2x higher odds of acute HBV vs those without diabetes –Persons ≥ 60 years, 1.5x higher odds of acute HBV NHANES data 1999–2010, antibody to HBV core antigen –Overall, 60% increase in adults with diabetes vs those without diabetes (P < 0.001) –Age 18–59 years, 70% increase (P < 0.001) –Age ≥ 60 years, 30% increase (P = 0.032) ACIP Presentation Slides. http://www.cdc.gov/vaccines/recs/acip/slides-oct11.htm. Accessed March 2012.

59. ACIP Presentation Slides. http://www.cdc.gov/vaccines/recs/acip/slides-oct11.htm. Accessed March 2012.

60. Transmission of HBV During Health Care Delivery High titer of HBV present absent visible blood –Example: with a viral load ~2 x 10 4 IU/mL even a microliter of blood that gets into a cut or is present on a needle stick can transfer virus Stable on environmental surfaces ≥ 7 days Transmission –Contaminated equipment (lancets, glucose meters, insulin pens) –Contaminated surfaces –Contaminated medication vials ACIP Presentation Slides. http://www.cdc.gov/vaccines/recs/acip/slides-oct11.htm. Accessed March 2012.

61. Misuse of Diabetes Equipment: Recent Patient Notifications Year, SettingEquipment Misused Length of Misuse Persons at Risk 2008, Hospital Insulin pen7 months908 2009, Hospital Insulin pen7 months2,114 2009, Community Health Center Multi-lancet finger stick device6 months283 2010, Health Fair Multi-lancet finger stick device1 day64 2011, HMO, Certified Diabetes Educator Multi-lancet finger stick device, insulin pen 5+ years2,345 Total at risk 5,714 ACIP Presentation Slides. http://www.cdc.gov/vaccines/recs/acip/slides-oct11.htm. Accessed March 2012.

62. Cost Effectiveness–HBV Vaccination of Adults with Diabetes ACIP Presentation Slides. http://www.cdc.gov/vaccines/recs/acip/slides-oct11.htm. Accessed March 2012. Age at Vaccination (years) Number Vaccinated with 10% Take-up Cost per QALY Saved 20–59528,047$75,094 60+774,394$2,760,753 All (20+)1,302,441$196,557

63. HBV Vaccination for Adults with Diabetes Mellitus HBV vaccination for unvaccinated adults with diabetes mellitus (type 1 and type 2) age 19 through 59 years, ASAP after diagnosis Unvaccinated adults ≥ 60 years with diabetes may be vaccinated at the discretion of the treating clinician –Consider risk and likelihood of an adequate immune response to vaccination CDC. MMWR Wkly Rep. 2011;60(50):1709-1711.

64. Hepatitis B Adult Vaccination Recommendations Vaccines: ENGERIX-B ® and RECOMBIVAX HB ® –Persons ≥ 20 years: 3-dose series given on a 0-, 1-, 6-month schedule –Adults on hemodialysis or other immunocompromising conditions: 1 dose of 40 µg/mL (Recombivax HB– dialysis formulation) administered on a 3-dose schedule or 2 doses of 20 µg/mL (Engerix-B) administered simultaneously on a 4-dose schedule at 0, 1, 2, and 6 months CDC. MMWR Wkly Rep. 2012;61(4):1-7.

65. Hepatitis B Vaccination Coverage 2010 National Health Interview Survey CDC. MMWR Wkly Rep. 2012;61(4):66-72.

66. Adult Immunization Schedule–2012 CDC. MMWR Wkly Rep. 2012;61(4):1-7.

67. High-Risk Groups for Vaccine-Preventable Diseases Pregnancy Immunocompromising conditions –Including hematopoietic malignancies, treatment with radiation, treatment with immunosuppressive drugs Anatomic or functional asplenia HIV infection Chronic conditions –Heart disease, chronic lung disease, chronic alcoholism, chronic liver disease Diabetes Kidney failure, end-stage renal disease, receipt of hemodialysis Men who have sex with men Health care personnel

68. Vaccines for Adults Based on Medical and Other Indications–2012 CDC. MMWR Wkly Rep. 2012;61(4):1-7.

69. Main Reason for Not Being Vaccinated: NIS, Adult 2007 Adapted from Euler GL. http://cdc.confex.com/cdc/nic2008/webprogram/Paper15390.html Accessed March 2012. N = 2,181Sample size→N = 3,624N = 843N = 221N = 1,812 *Not needed in the patient’s opinion; **Did not know refers to both not knowing the vaccine was needed and not knowing enough about the vaccine

70. Barriers to Adult Immunization Lack of coordination of adult immunization activities Lack of public knowledge Lack of provider recommendations for immunization Financial impediments to vaccinations Lack of access to, and utilization of, health care services by adults Lack of utilization of reminder or assessment systems Racial/ethnic disparities Health literacy Concern about adverse events Religious barriers Lack of trust of the scientific community Belief in misguided non-medical advice Adapted from National Vaccine Advisory Committee. Public Health Reports. 2012;127(S1):1-127.

71. Improving Vaccination Rates– Provider Issues Know the facts Recommend vaccinations to your patients Get organized and use systems approaches –Ensure offering and administration of vaccines  Automatic processes (standing orders) that empower nurses are effective  Address convenience, efficiency, durability  Electronic clinical decision-support systems  Immunization information system (registry) Evaluate and provide feedback Consider new paradigms –New venues –Extend vaccination season Practice what we preach (get vaccinated!) Nichol KL. Cleve Clin J Med. 2006;73:1009-1015.

72. Shots Immunization App - Free For iPhone/iPod, iPad, Android, Blackberry, and PC Select vaccine name for information on –High risk indications –Adverse reactions –Contraindications –Catch-up –Administration –Risk communication –Epidemiology www.ImmunizationEd.org Available at iTunes Store Content includes Childhood, Adolescent, and Adult Immunization Schedules for the US

73. ACP Immunization Advisor App by American College of Physicians http://itunes.apple.com/us/app/acp-immunization-advisor/id503636536. Accessed March 2012. Free on iTunes

74. Receive Updates from the CDC via Email: http://www.cdc.gov/vaccines/news/news-pubs.htm

75. Email Updates from the Immunization Action Coalition: http://www.immunize.org/subscribe/http://www.immunize.org/subscribe/

76. Provider Recommendation Can Overcome Negative Attitudes Among Patients Vaccination Rates Among High Risk Patients With Negative Attitudes Nichol KL, et al. J Gen Intern Med. 1996;11:673-677.

77. Strategies for Increasing Adult Vaccination Rates Standing Orders Computerized Record Reminder Chart Reminder Performance Feedback Home Visits Mailed/Telephoned Reminders Expanding Access in Clinical Settings Patient Education Personal Health Records Financial Incentives (HEDIS compliance) Adapted from CDC. http://www.cdc.gov/vaccines/recs/rate-strategies/adultstrat.htm. Accessed March 2012.

78. Standing Orders Are Among the Most Effective Strategies Nonphysicians offer and administer vaccinations Established with physician approved policies and protocols Locations: –Clinics and hospitals www.immunize.org/standingorders www.immunizationed.org/standingorders CDC. http://www.cdc.gov/vaccines/recs/rate-strategies/adultstrat.htm. Accessed March 2012. McKibbin LJ, et al. MMWR Recomm Rep. 2000;49 (RR1):15-26.

79. Patient and Provider Reminders Vaccinations Due or Past Due Patient/parent – Telephone, letter/postcard Provider –Computerized record reminders –Chart reminders Jacobson V, Szilagyi P. Cochrane Database Syst Rev. 2005;(3):CD003941.

80. Tailored Interventions for Inner-City Health Centers to Improve Vaccination Rates Nowalk M, et al. J Am Geriatr Soc. 2008;56:1177-1182. InfluenzaPneumococcal (≥ 65) ** **P < 0.001 vs 2000-2001 Tailored Interventions Standing orders Provider and patient education Walk-in influenza clinics Electronic prompts Patient reminders

81. Provider Assessment and Performance Feedback Retrospectively assess the delivery of vaccine(s) Incorporates principles of continuous improvement AFIX www.cdc.gov/vaccines/programs/afix/index.htmlwww.cdc.gov/vaccines/programs/afix/index.html –Assessment –Feedback –Incentives –eXchange Comprehensive Clinic Assessment Software Application (CoCASA) http://www.cdc.gov/vaccines/programs/cocasa/index.html http://www.cdc.gov/vaccines/programs/cocasa/index.html Immunization Information System (IIS) CDC. http://www.cdc.gov/vaccines/programs/afix/about/overview.html. Accessed March 2012. The Community Guide. http://www.thecommunityguide.org/vaccines/universally/index.html. Accessed March 2012.

82. Expanding Access Consider new paradigms –New venues, walk-in clinics –Extended hours for vaccinations –Extend vaccination season –Link Tdap and PPSV23 to influenza during expanded access Nichol KL. Cleve Clin J Med. 2006;73:1009-1015.

83. Additional Considerations for Your Practice For patients who come in for routine visits –Don’t miss opportunities to vaccinate –Screen for vaccination status –Use standing orders For patients who don’t come in routinely –Use outreach reminders: autodialing, texting, online patient portal –Expand access to make it convenient for all patients to get vaccines Communicate with patients about VPD outbreaks in the community Identify and empower a vaccine champion in the office Use flu season as a time to make a concerted focus on immunizations

84. Vaccine Education–Consider Your Audience Cognitive Style Main EffectVerbal ExpressionApproach Denialist Disbelieves scientific facts, despite overwhelming evidence, prone to conspiracy theories “I don’t believe what the data show, I don’t believe the vaccine is safe” Provide consistent messaging repeatedly over time from trustworthy sources Provide educational materials Solicit questions Avoid hard sell approach Use motivational interviewing Innumerate Cannot understand or has difficulty with numbers, probabilities, or risks “One in a million risk sounds high, for sure I’ll be the 1 that has a side effect, I’ll avoid the vaccine” Provide nonmathematical information, analogies, or comparators using a more holistic or emotive approach Adapted from Poland C, Poland G. Vaccine. 2011;29:6145-6148.

85. Vaccine Education–Consider Your Audience Cognitive Style Main EffectVerbal ExpressionApproach Fear-based Decision making based on fears “I heard that vaccines are harmful and I’m not going to get them” Understand source of fear Provide consistent positive approach Show risks in comparison to other daily risks Demonstrate risks of not receiving vaccines Use social norming approaches Heuristic Often appeals to availability heuristic “I remember GBS happened in 1977 after the flu vaccines, that must be common, and therefore I’m not getting a flu vaccine” Point out inconsistencies and fallacy of heuristic thinking Provide education materials Appeal to other heuristics Adapted from Poland C, Poland G. Vaccine. 2011;29:6145-6148.

86. Vaccine Education–Consider Your Audience Cognitive Style Main EffectVerbal ExpressionApproach Bandwagoning Primarily influenced by what others are doing/saying “If others are refusing the vaccine, there must be something to it, I’m going to skip getting the vaccine” Understand primary influencers Point out logical inconsistencies Use social norming and self- efficacy approaches Analytical Left brain thinking, facts are paramount “I want to see the data so I can make a decision” Provide data as requested Review analytically with patient Adapted from Poland C, Poland G. Vaccine. 2011;29:6145-6148.

87. Communicating with Adults About Recommended Vaccines Expand the spectrum of vaccine education Understand vaccine psychology and cognitive decision making Learn from other health education endeavors Expand the intended audience Expand the platform of vaccine education Poland C, Poland G. Vaccine. 2011;29:6145-6148.

88. Economics of Vaccination Orenstein W, et al. Clin Pharmacol Ther. 2007;82(6):764-768. Freed G, et al. Pediatrics. 2009;124:S459-465. AAP. https://www2.aap.org/immunization/pediatricians/pdf/Vacc_survival_insert.pdf. Accessed March 2012. Costs –Vaccine purchase price –Non-vaccine costs  Vaccine administration, ordering, storage, record keeping, insurance against vaccine loss Reimbursements –Private insurers  Variation in provider purchase prices and payer reimbursement –Incentives  “Pay for Performance” (HEDIS, other quality measures) –Medicare, Medicaid –Affordable Care Act

89. Summary The burden of vaccine-preventable diseases in the US is greatest among adults Substantial improvement in adult immunization coverage is needed Educate adults about recommended vaccines –Individualize your approach –Address misconceptions and concerns about vaccine safety –Your recommendation makes a difference! Stay current with the immunization schedule and recommendations Establish an immunization champion in your practice Identify and address barriers Implement organizational and systems strategies

90. Resources for Providers Immunization Schedules www.cdc.gov/vaccines/recs/schedules/ www.immunizationed.org (point of care details; smartphone apps) ACIP recommendations & provisional recommendations www.cdc.gov/vaccines/pubs/ACIP-list.htm www.cdc.gov/vaccines/recs/provisional/default.htm The Immunization Action Coalition www.immunize.org/ The Guide to Community Preventive Services. Vaccine recommendations www.thecommunityguide.org/vaccines/index.html Assessment, Feedback, Incentives, and Exchange (AFIX) www.cdc.gov/vaccines/programs/afix/index.html Comprehensive Clinic Assessment Software Application (CoCASA) http://www.cdc.gov/vaccines/programs/cocasa/index.html National Foundation for Infectious Diseases www.nfid.org Vaccine Adverse Event Reporting System (VAERS) vaers.hhs.gov/professionals/index

91. Resources for Patients Guide to evaluating information on the web www.cdc.gov/vaccines/vac-gen/evalwebs.htm CDC Vaccine Information Statements (VISs) http://www.cdc.gov/vaccines/pubs/vis/default.htm Vaccine Safety www.cdc.gov/Features/VaccineSafety National Network for Immunization Information (NNII) www.immunizationinfo.org Allied Vaccine Group www.vaccine.org Immunization Action Coalition (IAC) www.vaccineinformation.org/ Vaccine Education Center at CHOP www.vaccine.chop.edu TCH Center for Vaccine Awareness and Research www.texaschildrens.org/carecenters/vaccine/default.aspx American College of Physicians http://www.acponline.org/patients_families/immunization/