2014 Adult Immunization Update Richard K Zimmerman MD

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2014 Adult Immunization Update Richard K Zimmerman MD MPH University of Pittsburgh School of

2014 Adult Immunization Update Richard K Zimmerman MD MPH University of Pittsburgh School of Medicine

Conflicts of Interest �Research grants from Pfizer (adolescent vaccine) and Sanofi

Conflicts of Interest �Research grants from Pfizer (adolescent vaccine) and Sanofi

Policy considerations: �Is the vaccine effective? �Is the vaccine safe? �Is the public health

Policy considerations: �Is the vaccine effective? �Is the vaccine safe? �Is the public health impact based on amount of potentially preventable disease sufficient? �Is it programmatically feasible to add more injections �Is it cost-effective? �ACIP uses GRADE �Explicit, evidence-based grading process

CDC

CDC

Source ACIP meeting

Source ACIP meeting

Strain selection 2014 -15 �WHO recommends the same composition for the Northern Hemisphere 2014

Strain selection 2014 -15 �WHO recommends the same composition for the Northern Hemisphere 2014 -15 influenza vaccines as for 2013 -14: �an A/California/7/2009 (H 1 N 1)pdm 09 -like virus; �an A/Texas/50/2012 (H 3 N 2)-like virus; �a B/Massachusetts/2/2012 -like virus. (Yamagata lineage) �for quadrivalent vaccines, add B/Brisbane/60/2008 -like virus (Victoria lineage)

Fluzone High Dose (HD) Vaccine � 60 mcg per strain compared to 15 mcg

Fluzone High Dose (HD) Vaccine � 60 mcg per strain compared to 15 mcg typically �Prefilled syringes �No adjuvant or preservative �Currently only trivalent �Licensed in December 2009 � 13 million doses used in first three seasons �Penetrance in market 20% among elderly in past

IIV-HD Efficacy Trial � 32, 000 persons >65 years in 126 study sites in

IIV-HD Efficacy Trial � 32, 000 persons >65 years in 126 study sites in US and Canada �Randomized and blinded trial �Laboratory confirmation on NP swab: �PCR �Culture

October 2013 ACIP Meeting

October 2013 ACIP Meeting

October 2013 ACIP Meeting

October 2013 ACIP Meeting

October 2013 ACIP Meeting

October 2013 ACIP Meeting

October 2013 ACIP Meeting

October 2013 ACIP Meeting

October 2013 ACIP Meeting

October 2013 ACIP Meeting

Pneumococcal Vaccines �Two types: � PPSV 23 – 23 valent pneumococcal polysaccharide � PCV

Pneumococcal Vaccines �Two types: � PPSV 23 – 23 valent pneumococcal polysaccharide � PCV 13 – 13 valent pneumococcal conjugate �Existing recommendation for PPSV 23 for one dose at age >65 years �PCV 13 is FDA licensed for adults � serotypes 1, 3, 4, 5, 6 A, 6 B, 7 F, 9 V, 14, 18 C, 19 A, 19 F and 23 F �Deferred recommendation until CAPITA data available and until herd (indirect) effect data from childhood use of PCV 13

ACIP Meeting

ACIP Meeting

ACIP Meeting

ACIP Meeting

ACIP Meeting

ACIP Meeting

ACIP Meeting

ACIP Meeting

ACIP Meeting

ACIP Meeting

ACIP Meeting

ACIP Meeting

Expected public health impact of adding PCV 13 at age 65 years to existing

Expected public health impact of adding PCV 13 at age 65 years to existing PPSV 23 recommendations (base case) Health Outcomes IPD Change in outcome compared to existing PPSV 23 recommendation -226 Inpatient NBP -4, 961 Outpatient NBP -7, 252 Deaths (IPD) -33 Deaths (NBP) -332 QALYs 3, 053 Life-years 4, 627 Stoecker, ACIP June 2014 27

Cost-effectiveness of adding PCV 13 at age 65 years to existing PPSV 23 recommendations

Cost-effectiveness of adding PCV 13 at age 65 years to existing PPSV 23 recommendations (base case) Outcomes Change in outcome compared to existing PPSV 23 recommendation Total Cost (Millions) $189 Medical (Millions) Vaccine total cost (Millions) -$132 Cost/QALY gained $62, 065 $40, 949 Cost/Life-year gained $321 Stoecker, ACIP June 2014 28

CDC: Quality of Evidence for using PCV 13 to prevent IPD and pneumonia (updated

CDC: Quality of Evidence for using PCV 13 to prevent IPD and pneumonia (updated GRADE-2014) Outcome IPD Risk of Inconsis- bias tency No N/A Indirectness Impreci- Quality of sion evidence Serious No serious 21 No serious 1 serious Pneumonia No serious 1 Indirectness due to different comparison group a. Placebo instead of PPSV b. PPSV efficacy against IPD among older adults = 50 -80%

Critical Outcomes: Invasive Pneumococcal Disease (IPD) and Pneumococcal Non-bacteremic Pneumonia Study/population CAPITA Adults 65+

Critical Outcomes: Invasive Pneumococcal Disease (IPD) and Pneumococcal Non-bacteremic Pneumonia Study/population CAPITA Adults 65+ Netherlands Endpoint Vaccine Efficacy (95% CI) PCV 13 -serotype IPD 75% (41%, 91%) PCV 13 -serotype non-bacteremic pneumonia 45% (14%, 65%) What effect might we expect among persons >65 years old in the US? CAPITA, ACIP June 2014

CDC: How many persons >65 years old would need to be vaccinated to prevent

CDC: How many persons >65 years old would need to be vaccinated to prevent a single case of PCV 13 -type IPD or a single case of PCV 13 -type CAP? Outcome (PCV 13 -type) Baseline incidence (per 100, 000 population) 1. 2. 3. 4. 5. Vaccine efficacy Number (95% CI) needed to vaccinate 5 IPD 6. 51 75% (41%, 91%)4 20, 400 (16, 950 - 37, 000) Caveat: VE vs. placebo Inpatient CAP 137. 52 45% (14%, 65%)4 1, 620 (1, 110 - 5, 130) Outpatient CAP 2013 45% (14%, 65%)4 1, 110 (760 -3, 500) Baseline estimates assume 10% of all CAP due to PCV 13 types Total CAP - 656 (454 -2, 110) - PCV 13 -type IPD rate among adults >65 years old in the US. CDC, ABCs, 2013 Simonsen et al Lancet Resp. Med 2014 Nelson et al. Vaccine 2008 CAPITA Number-needed-to vaccinate (NNV) =1 / (Ratebaseline – Ratevaccinated)

CDC: Estimating cases potentially preventable annually among adults 65 years or older Outcome (PCV

CDC: Estimating cases potentially preventable annually among adults 65 years or older Outcome (PCV 13 type) IPD 2015 • 20% reduction due to herd effects* • PCV 13 direct effects** • Coverage 10% (5%-30%) 2019 • 86% reduction due to herd effects* • PCV 13 direct effects** • Coverage 30% (20%-60%) 160 (80 -480) 80 (50 -170) Inpatient CAP 2, 030 (1, 020 -6, 090) 1, 070 (700 -2, 130) Outpatient CAP 2, 970 (1, 480 -8, 900) 1, 560 (1, 040 – 3, 120) Total CAP 5, 000 (2, 500 -14, 990) 2, 630 (1, 740 – 5, 250) *Based on post-PCV 7 reductions observed between 2003 and 2009 **Assume PCV 13 VE =75% (IPD) and 45% (CAP) 33

ACIP WG Conclusions: Sequence and intervals for PCV 13 and PPSV 23 use PCV

ACIP WG Conclusions: Sequence and intervals for PCV 13 and PPSV 23 use PCV 13 should be given first when possible q Interval between PCV 13 followed by PPSV 23: 6 -12 months q Interval for PCV 13 when given post-PPSV 23: >1 year q Include flexibility in the guidance if doses cannot be administered within the recommended window: If a second dose cannot be given during this time window, a dose can be given later during the next visit q 34

CDC: Categories of adults >65 years old to consider Received PCV 13 previously? No

CDC: Categories of adults >65 years old to consider Received PCV 13 previously? No Yes No additional PCV 13 doses needed* *ACIP 2012 recommendations for PCV 13 use among adults with immunocompromising conditions (MMWR October 2012) Received one or more doses of PPSV 23 previously? Yes PCV 13 dose No PCV 13 dose followed by PPSV 23 35

CDC: Adults >65 years of age with no previous pneumococcal vaccine (PCV 13 or

CDC: Adults >65 years of age with no previous pneumococcal vaccine (PCV 13 or PPSV 23) �Adults >65 years who have not previously received pneumococcal vaccine or whose previous vaccination history is unknown: �receive a dose of PCV 13 first, �followed by a dose of PPSV 23 � 6 -12 months later � If not feasible, during next visit � Not co-administered 36

ACIP meeting

ACIP meeting

60 year old with a painful forehead

60 year old with a painful forehead

Herpes Zoster Epidemiology � Incidence � ~ 3 -4 per 1, 000 person years

Herpes Zoster Epidemiology � Incidence � ~ 3 -4 per 1, 000 person years � 1 million cases in U. S. annually � Lifetime risk � 30% overall � 50% of individuals living until 85 years of age � Complications: � Post herpetic neuralgia (13% of those >60 years) � Ophthalmic � Nerve Palsies � Bacterial superinfection Gnann J et al. N Engl J Med. 2002; Katz J et al. Clin Infect Dis. 2004; Ragozzino M et al. Medicine 1982.

Shingles Prevention Study

Shingles Prevention Study

Results

Results

Zoster Vaccine Efficacy against Burden of Illness

Zoster Vaccine Efficacy against Burden of Illness

Zoster vaccine �Recommended once by ACIP to persons >60 years of age �ACA requires

Zoster vaccine �Recommended once by ACIP to persons >60 years of age �ACA requires commercial insurances subject to ACA to pay for ACIP recommended vaccines with first dollar coverage (no copays) �So, almost all commercial insurances pay �Medicare is part D with doughnut hole possibility �So, give it ages 60 -64 when commercial insurance offers first dollar coverage

Misuse of Diabetes Equipment: Recent Patient Notifications Recommendation for bloodborne pathogen testing to potentially

Misuse of Diabetes Equipment: Recent Patient Notifications Recommendation for bloodborne pathogen testing to potentially exposed Year, Setting Equipment misused Insulin pen Length of misuse 7 months Persons at risk 908 2008, Hospital 2009, Hospital Insulin pen 7 months 2114 2009, Community Multi-lancet finger stick 6 months Health Center device 283 2010, Health Fair 64 Multi-lancet finger stick 1 day device 2011, HMO, Multi-lancet finger stick 5+ years certified diabetes device, insulin pen educator Total at risk 2345 5714

Acute Hepatitis B Disease Adults with Diabetes, 2009 -2010 • Adults with diabetes without

Acute Hepatitis B Disease Adults with Diabetes, 2009 -2010 • Adults with diabetes without “Other” hepatitis B risk factors† – Ages <60 years, 2 X higher odds of hepatitis B – Ages ≥ 60 years, 1. 5 X higher odds of hepatitis B* †”Other” risk factors included injecting drug use, men who have sex with men, and HIV risk associated behaviors. *Not statistically significant (small sample size) Reilly M. IDSA 2011

ACIP

ACIP

Acute Hepatitis B �~30% cases symptomatic; �average 1 -4 months �~40% cases hospitalized �

Acute Hepatitis B �~30% cases symptomatic; �average 1 -4 months �~40% cases hospitalized � 1%-2% cases fulminant liver failure �NNDSS 2009, Sentinel Counties 2002 -2005; EIP Sites, 2005 -2007 ; CDC unpublished �Case fatality rate � 1. 3% overall � 2%-4% ages ≥ 50 year � 6%-18% older adults in outbreak settings

Past Hepatitis B Infection in NHANES 1999 -2010 � • Nationally representative survey of

Past Hepatitis B Infection in NHANES 1999 -2010 � • Nationally representative survey of noninstitutionalized adults; tested for antibody to �hepatitis B core antigen (anti-HBc) � • Unadjusted prevalence of anti-HBc among �adults with diabetes (vs. without diabetes)* �– Overall, 60% increase (p<0. 001) �– Ages 18 -59 years, 70% increase (p<0. 001) �– Ages ≥ 60 years, 30% increase (p=0. 032) �* CDC unpublished data; updated 10/31/2011

Hepatitis B Vaccination Adults with Diabetes • Seroprotection remains high in the majority of

Hepatitis B Vaccination Adults with Diabetes • Seroprotection remains high in the majority of adults to age 60 years • Younger age, fewer co-morbidities – Vaccination soon after diabetes diagnosis maximizes protection • Fewer adults ≥ 60 years fully protected • No special safety concerns

Hepatitis B vaccine efficacy in DM Author Event Rate (%): Placebo Even Rate Vaccine

Hepatitis B vaccine efficacy in DM Author Event Rate (%): Placebo Even Rate Vaccine Adverse (%): Efficacy Events* Vaccinated 4. 8 80 No serious Coutinho 23. 8 Crosnier 12. 3 3. 6 71 No serious Dienstag 0. 8 0. 2 80 No serious Francis 20. 9 9. 2 82 No serious Szmuness 80 35. 0 7. 6 78 No serious Szmuness 82 9. 9 2. 2 77 No serious *Study sizes not sufficient to detect rare adverse events, †Not reported by study, vaccine efficacy= incidence in placebo recipients minus incidence in vaccine recipients, divided by incidence in placebo recipients (0. 75 and 0. 15, respectively, for Dienstag), crude rate not accounting for person-time follow-up, ‡Does not include anti-HBc positivity without enzyme

Number of Persons with Diabetes Needed to Vaccinate to Prevent One HBV Infection: Modeling

Number of Persons with Diabetes Needed to Vaccinate to Prevent One HBV Infection: Modeling Analysis Age (years) at vaccination 20 -59 Number needed to vaccinate 124 ≥ 50 1071 ≥ 20 261 T Hoerger et al. Research Triangle Institute, Int. 2011.

Cost-effectiveness of Hepatitis B vaccination in DM Age at vaccination Number vaccinated with 10%

Cost-effectiveness of Hepatitis B vaccination in DM Age at vaccination Number vaccinated with 10% vaccine update Cost per QALY saved 20 -59 528, 047 $75, 094 60+ 774, 394 $2, 760, 753 Vaccinate adults with DM who <60 years old Optional >60 years with DM

Evidence Review: Task Force on Community Preventive Services Increase Patient Demand Patient reminders Enhance

Evidence Review: Task Force on Community Preventive Services Increase Patient Demand Patient reminders Enhance Access Office hours express vaccination After hours express vaccine-only clinics Provider Reminders and Office Systems Standing order programs (SOPs) Prompts in EMRs Combination of 2 or 3 strategic approaches led to a 16% point increase in rates. Multiple interventions within a single strategic approach increased rates only 4% points.

4 Pillars of Successful Vaccination Programs 4 pillarstoolkit. pitt. edu

4 Pillars of Successful Vaccination Programs 4 pillarstoolkit. pitt. edu

Pillar 1: Convenient Vaccination Programs �Extended vaccination season � Starts when influenza vaccine arrives

Pillar 1: Convenient Vaccination Programs �Extended vaccination season � Starts when influenza vaccine arrives � Continues into the influenza disease season for unvaccinated �Season unpredictable & some benefit possible � 2 waves of influenza may occur

Pillar 1: Convenient Influenza Vaccination Programs �Express vaccination services �Vaccination only services: �Dedicated evening

Pillar 1: Convenient Influenza Vaccination Programs �Express vaccination services �Vaccination only services: �Dedicated evening or weekend vaccine-only services �Walk-in vaccination station �Nursing vaccination visits

Pillar 2: Patient Notification �About Convenient Vaccination Services �Notification Methods �Autodialer �Email/text �Office posters/videos

Pillar 2: Patient Notification �About Convenient Vaccination Services �Notification Methods �Autodialer �Email/text �Office posters/videos �Answering service “on-hold” messages �Mail

Pillar 2: Patient Notification • Physician recommendation is essential to patient acceptance • Makes

Pillar 2: Patient Notification • Physician recommendation is essential to patient acceptance • Makes a difference among patients hesitant to be vaccinated, as shown in figure MMWR 1988; 37: 657 -61

Providers should discuss serious nature of vaccine preventable diseases Families Fighting Flu www. familiesfightingflu.

Providers should discuss serious nature of vaccine preventable diseases Families Fighting Flu www. familiesfightingflu. org

Pillar 3: Enhanced Office Vaccination Systems � Assessment of influenza vaccination as a routine

Pillar 3: Enhanced Office Vaccination Systems � Assessment of influenza vaccination as a routine part of the office visit by nursing staff: � Prompts in EMR � Health maintenance or immunization section review � Routinely address “Is vaccination status up to date? ” as part of vital signs � Empowering staff to vaccinate by standing orders � Combination of assessment and SOPs should reduce missed opportunities

Pillar 4: Motivation • Ongoing motivation is a key to success • Set goals

Pillar 4: Motivation • Ongoing motivation is a key to success • Set goals for improving rates • Identify an Immunization Champion • Champion monitors weekly progress towards goals • Shares progress with team • Celebrate achievements • Consider rewards

SOP Case Study - Urban Practice Effective office manager and lead physician (Immunization Champions)

SOP Case Study - Urban Practice Effective office manager and lead physician (Immunization Champions) Leaders inspired staff to take responsibility for assessing vaccination status and vaccinating patients, using SOPs Staff appreciated regular feedback on performance and comparison with other sites Staff believed that their performance made the difference vaccination rates Influenza vaccination rates in one urban practice Age group 18 -49 years 49 -64 years ≥ 65 years 2010 (before 4 pillars toolkit) 23% 2011 (after 4 pillars toolkit) 32% P value 35% 46% <. 01 52% 69% <. 001

Links to Resources www. immunizationed. org/shotsonline. aspx Detailed information on specific vaccines Click on

Links to Resources www. immunizationed. org/shotsonline. aspx Detailed information on specific vaccines Click on buttons for more details CDC www. cdc. gov/vaccines IAC: www. immunize. org