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  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 Emergency hospital during 1918 influenza epidemic, Camp Funston, Kansas 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.

  5. Seasonal Influenza Has a Huge Annual Impact in the United States Reminder: Huge variability in the number of influenza cases each year Based on 2003 US population demographics Molinari NA, et al. Vaccine. 2007;25:5086-5096.

  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 adultswithout 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 †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 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 CDC. MMWR Morb Mortal Wkly Rep. 2010;59(RR8):1-62.

  9. Influenza Vaccination Coverage2010–2011 Influenza Season 90% HP: Healthy People 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.

  10. Place of Influenza Vaccination Among Adults2010–2011 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/BloodVaccinesandOtherBiologics/VaccinesandRelatedBiologicalProductsAdvisoryCommittee/UCM296193.pdf. Accessed March 2012.

  12. 2012–2013 Influenza Season 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 2nd and 3rd 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 • Nonrandomized, prospective, observational cohort study • Navajo and White Mountain Apache Indian Reservations • N = 1160 mother infant pairs; birth–6 months Eick A, et al. Arch Pediatr Adolesc Med. 2011;165:104-111.

  16. 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 likelyto have influenza hospitalization vs infants of unvaccinated mothers Poehling K, et al. Am J Obstet Gynecol. 2011;204(6 Suppl 1):S141-148.

  17. Influenza Vaccination Coverage LevelsHealth 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 • CDC. MMWR Wkly Rep. 2011;60(32):1073-1077.

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

  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. 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 Risk Factors for Pneumococcal Disease CDC. http://www.cdc.gov/vaccines/pubs/pinkbook/pneumo.html. Accessed March 2012.

  24. Changes in Overall Invasive Pneumococcal Disease, 1998–2007 PCV7 introduced Age Group 2007 vs baseline* (years) (% reduction) 120 < 5 76 100 5–17 43 40 18–49 50–64 18 80 Cases/100,000 Population ≥ 65 37 60 40 20 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Year *Baseline is 1998-1999 Pilishvili T, et al. J Infect Dis. 2010;201:32-41.

  25. Invasive Pneumococcal Disease Among Adults ≥ 65 Years, 1998–2007 PCV7 introduced 40 35 30 25 Cases/100,000 Population Serotype group 20 PCV7 type 15 Non-PCV7 type Included in PCV13 19A 10 5 0 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Year Pilishvili T, et al. J Infect Dis. 2010;201:32-41.

  26. S. Pneumoniae ABCs Data USA: 2010Invasive 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–2010IPD in All Age Groups Meningitis 6% Bacteremia without Focus 17.9% Not Categorized 6.8% Pneumonia with Bacteremia 69.3% 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) IPD: invasive pneumococcal disease; NPP: nonbacteremic pneumococcal pneumonia Weycker D, et al. Vaccine. 2010;28:4955-4960.

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

  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 Number of Cigarettes Smoked Nonsmoker Exposure to Tobacco Smoke Nuorti JP, et al. N Engl J Med. 2000;342:681-689.

  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 Coverage2010 National Health Interview Survey HP: Healthy People CDC. MMWR Wkly Rep. 2012;61(4):66-72.

  34. Effectiveness of PPSV23 in Adults2008 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* *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 Smith KJ, et al. JAMA. 2012;307:804-812.

  38. Estimates for Vaccination StrategiesPCV13 and PPSV23 for Adults ≥ 50 Years 16,000 IPD Base Case 14,000 NPP Base Case IPD Worst Case 12,000 • NPP Worst Case† 10,000 8,000 Cases Prevented 6,000 4,000 2,000 0 PCV13 @ 50 yrs PCV13 @ 50 and 65 yrs PCV13 @ 50 and 65 yrs ≤ 65 yrs with HR ≤ 65 yrs with HR PPSV23 @ 65 yrs PPSV23 @ 75 yrs (PPSV23) (PCV13) IPD: invasive pneumococcal disease NPP: hospitalized nonbacteremic pneumococcal pneumonia HR: high risk conditions †PCV13 effectiveness set at low range estimates against nonbacteremic pneumonia Adapted from Smith KJ, et al. JAMA. 2012;307:804-812.

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

  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 100 80 < 1 yr 1–6 yrs 7–10 yrs 11–19 yrs 20+ yrs 60 Incidence (per 100,000) 40 20 0 1990 1995 2000 2005 2010 CDC Pertussis Surveillance. http://www.cdc.gov/pertussis/surv-reporting.html. Accessed March 2012.

  43. Source of Pertussis Transmitted to Infants ≤ 6 Months Old • 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 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, 3rd or late 2nd 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 Coverage2010 National Health Interview Survey Tetanus vaccination, past 10 years Tetanus vaccination, including pertussis, past 5 years The rate of incident tetanus is very low CDC. MMWR Wkly Rep. 2012;61(4):66-72.

  47. Human Papillomavirus • 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 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.

  48. Available HPV Vaccines *Licensed for use in females and males CDC. MMWR Wkly Rep. 2010;59(20):626-632.

  49. HPV–Recommendations for FemalesQuadrivalent 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.