Richard K Zimmerman MD MPH University of Pittsburgh School of Medicine.
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Transcript of Richard K Zimmerman MD MPH University of Pittsburgh School of Medicine.
Richard K Zimmerman MD MPH
University of Pittsburgh School of Medicine
Research grants from Pfizer (adolescent vaccine) and Sanofi
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
injectionsIs it cost-effective?ACIP uses GRADE
Explicit, evidence-based grading process
CDC
Source ACIP meeting
WHO recommends the same composition for the Northern Hemisphere 2014-15 influenza vaccines as for 2013-14: an A/California/7/2009 (H1N1)pdm09-like virus; an A/Texas/50/2012 (H3N2)-like virus; a B/Massachusetts/2/2012-like virus. (Yamagata
lineage)for quadrivalent vaccines, add B/Brisbane/60/2008-like
virus (Victoria lineage)
60 mcg per strain compared to 15 mcg typically Prefilled syringesNo adjuvant or preservativeCurrently only trivalentLicensed in December 200913 million doses used in first three seasonsPenetrance in market 20% among elderly in past
32,000 persons >65 years in 126 study sites in US and Canada
Randomized and blinded trialLaboratory confirmation on NP swab:
PCRCulture
October 2013 ACIP Meeting
October 2013 ACIP Meeting
October 2013 ACIP Meeting
October 2013 ACIP Meeting
October 2013 ACIP Meeting
Two types:PPSV 23 – 23 valent pneumococcal polysaccharidePCV13 – 13 valent pneumococcal conjugate
Existing recommendation for PPSV23 for one dose at age >65 years
PCV13 is FDA licensed for adultsserotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F
and 23FDeferred recommendation until CAPITA data
available and until herd (indirect) effect data from childhood use of PCV13
ACIP Meeting
ACIP Meeting
ACIP Meeting
ACIP Meeting
ACIP Meeting
ACIP Meeting
Health OutcomesChange in outcome compared to
existing PPSV23 recommendation
IPD -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
OutcomesChange in outcome
compared to existing PPSV23 recommendation
Total Cost (Millions) $189
Medical (Millions) -$132 Vaccine total cost (Millions) $321
Cost/QALY gained $62,065
Cost/Life-year gained $40,949
Stoecker, ACIP June 2014
28
Outcome Risk of
bias
Inconsis-
tency
Indirectness Impreci-
sion
Quality of
evidence
IPD No
serious
N/A Serious No serious 21
1Indirectness due to different comparison groupa. Placebo instead of PPSVb. PPSV efficacy against IPD among older adults = 50-80%
Pneumonia No
serious
N/A No serious No serious 1
Study/population Endpoint
Vaccine Efficacy
(95% CI)
CAPITA
Adults 65+
Netherlands
PCV13-serotype IPD 75% (41%, 91%)
CAPITA, ACIP June 2014
What effect might we expect among persons >65 years old in the US?
PCV13-serotype non-bacteremic
pneumonia 45% (14%, 65%)
1. PCV13-type IPD rate among adults >65 years old in the US. CDC, ABCs, 2013
2. Simonsen et al Lancet Resp. Med 2014
3. Nelson et al. Vaccine 2008
4. CAPITA
5. Number-needed-to vaccinate (NNV) =1 / (Ratebaseline – Ratevaccinated)
Outcome(PCV13-type)
Baseline incidence(per 100,000 population)
Vaccine efficacy (95% CI)
Number needed to vaccinate5
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)
Baseline estimates assume 10% of all CAP due to PCV13 -typesOutpatient CAP 2013 45%
(14%, 65%)4
1,110 (760-3,500)
Total CAP - - 656(454-2,110)
Outcome (PCV13 type)
2015•20% reduction due to herd effects*•PCV13 direct effects**•Coverage 10% (5%-30%)
2019•86% reduction due to herd effects* •PCV13 direct effects**•Coverage 30% (20%-60%)
IPD 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-PCV7 reductions observed between 2003 and 2009**Assume PCV13 VE =75% (IPD) and 45% (CAP)
33
PCV13 should be given first when possible Interval between PCV13 followed by PPSV23:
6-12 months Interval for PCV13 when given post-PPSV23:
>1 year 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
34
*ACIP 2012 recommendations for PCV13 use among adults with immunocompromising conditions (MMWR October 2012)
35
Received PCV13 previously?
Yes No
No additional PCV13 doses needed*
Received one or more doses of PPSV23 previously?
Yes No
PCV13 dose
PCV13 dosefollowed by PPSV23
36
Adults >65 years who have not previously
received pneumococcal vaccine or whose previous vaccination history is unknown:
receive a dose of PCV13 first, followed by a dose of PPSV23
6-12 months laterIf not feasible, during next visitNot co-administered
ACIP meeting
Incidence~ 3-4 per 1,000 person years
1 million cases in U.S. annually Lifetime risk
30% overall50% of individuals living until 85 years of age
Complications:Post herpetic neuralgia (13% of those >60 years)OphthalmicNerve PalsiesBacterial superinfection
Gnann J et al. N Engl J Med. 2002; Katz J et al. Clin Infect Dis. 2004; Ragozzino M et al. Medicine 1982.
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 possibilitySo, give it ages 60-64 when commercial insurance
offers first dollar coverage
Year, Setting Equipment misused Length of misuse
Persons at risk
2008, Hospital Insulin pen 7 months 908
2009, Hospital Insulin pen 7 months 2114
2009, Community Health Center
Multi-lancet finger stick device
6 months 283
2010, Health Fair Multi-lancet finger stick device
1 day 64
2011, HMO, certified diabetes educator
Multi-lancet finger stick device, insulin pen
5+ years 2345
Total at risk 5714
• Adults with diabetes without “Other” hepatitis B risk factors†
– Ages <60 years, 2X higher odds of hepatitis B
– Ages ≥60 years, 1.5X 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
~30% cases symptomatic; average 1-4 months ~40% cases hospitalized1%-2% cases fulminant liver failureNNDSS 2009, Sentinel Counties 2002-2005; EIP
Sites, 2005-2007 ;CDC unpublishedCase fatality rate
1.3% overall2%-4% ages ≥50 year6%-18% older adults in outbreak settings
• Nationally representative survey of noninstitutionalized adults; tested for antibody to
hepatitis B core antigen (anti-HBc)• Unadjusted prevalence of anti-HBc amongadults 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
• 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
AuthorEvent Rate
(%): PlaceboEven Rate
(%): Vaccinated
Vaccine
Efficacy
Adverse Events*
Coutinho 23.8 4.8 80 No serious
Crosnier 12.3 3.6 71 No serious
Dienstag 0.8 0.2 80 No serious
Francis 20.9 9.2 82 No serious
Szmuness80 35.0 7.6 78 No serious
Szmuness82 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 elevation
Age (years) at vaccination
Number needed to vaccinate
20-59 124
≥50 1071
≥20 261
T Hoerger et al. Research Triangle Institute, Int. 2011.
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
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.
4pillarstoolkit.pitt.edu
Extended vaccination season Starts when influenza vaccine arrives Continues into the influenza disease season for unvaccinated
Season unpredictable & some benefit possible2 waves of influenza may occur
Express vaccination servicesVaccination only services:
Dedicated evening or weekend vaccine-only services
Walk-in vaccination stationNursing vaccination visits
About Convenient Vaccination ServicesNotification Methods
AutodialerEmail/textOffice posters/videosAnswering service “on-hold” messagesMail
MMWR 1988;37:657-61
• Physician recommendation is essential to patient acceptance
• Makes a difference among patients hesitant to be vaccinated, as shown in figure
Pillar 2: Patient Notification
Providers should discuss serious nature of vaccine preventable diseases
Assessment of influenza vaccination as a routine part of the office visit by nursing staff:Prompts in EMRHealth maintenance or immunization section
review Routinely address “Is vaccination status up to
date?” as part of vital signsEmpowering staff to vaccinate by standing
orders Combination of assessment and SOPs should
reduce missed opportunities
• 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
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
Age group
2010 (before 4 pillars toolkit)
2011 (after 4 pillars toolkit)
P value
18-49 years
23% 32% <.001
49-64 years
35% 46% <.01
≥65 years
52% 69% <.001
Influenza vaccination rates in one urban practice
www.immunizationed.org/shotsonline.aspx
Detailed information on specific vaccines Click on buttons for more details
CDC www.cdc.gov/vaccinesIAC: www.immunize.org