Improving Adult Vaccination Protecting our Most Vulnerable

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Improving Adult VaccinationProtecting our Most
Vulnerable

• Dale W. Bratzler, DO, MPH
• QIOSC Medical Director
• Oklahoma Foundation for Medical Quality, Inc.

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Vaccine Preventable Disease
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Deaths Due to Vaccine-preventable Diseases (VPDs)

• Adults
• 99 of VPD deaths
• 30,000 to 70,000 each year
• Children
• 1 of VPD deaths
• 100 to 300 each year

Annual VPD Deaths
VPD Vaccine Preventable Disease Source CDC,
Institute of Medicine
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Deaths Due to Vaccine Preventable Diseases - US,
1989-1998
630k (90 in elderly)
11k (reported cases though the actual number is
likely 5-10 times higher)
VPD vaccine preventable diseases. MMWR 2001 48
(RR-53) Thompson et al. JAMA 2003 289 179
Feikin DR, et al. Am J Public Health 2000 90
223-9.
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Influenza

• Affects 5-20 of the population each year
• Causes more than 200000 hospitalizations each
  year
• Symptoms
• Fever, headache, fatigue, dry cough, sore throat,
  runny nose, myalgias, GI symptoms

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Complications of Influenza

• Bacterial infections
• Pneumonia
• Sinus and ear infections in children
• Cerebrovascular and cardiac disease
• Increases risk of stroke
• Increases AMI and HF admissions
• Exacerbations of COPD or asthma
• Increases blood sugars in diabetics
• Death

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http//www.facesofinfluenza.org/photo_gallery.php
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Spread of Influenza

• Respiratory droplets
• Person-to-person
• Contagious from one day prior to the onset of
  symptoms to up to 5 days after the onset of
  symptoms

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Influenza A Virus
Hemagglutinin (H)16 subtypes(attachment,
penetration)
Neuraminidase (NA)9 subtypes(release)
8 viral genes(assembly, replication)
M2 protein(penetration)
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Trivalent vaccine Live attenuated
vaccine Contain inactivated fragments of 2 A
viruses and 1 B virus A/New Caledonia/20/99(H1N1)
A/California/7/2004(H3N2)-like virus B/Shanghai/36
1/2002-like virus b
Oseltamivir (Tamiflu) Zanamivir (Relenza) Inhibit
neuraminidase
HA and NA antigens change with time
Amantadine (Symmetrel) rimantidine
(Flumadine) Mechanism??
CDC Natl Immunization Program
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Mechanism of Action of Neuraminidase Inhibitors
Moscona A. N Engl J Med 20053531363-1373
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Influenza Antigenic Drift and Shift
Hemagglutinin
Neuraminidase
Drift
Shift
Influenza Virus
Reassortment (pigs, poultry, and people)
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Past Antigenic Shifts
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Influenza Vaccines A Trivalent Defense
Type AH3N2
Type AH1N1
Influenza Protection
Type B
CDC. MMWR Recomm Rep. 200554(RR-8)1-40.
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http//www.cdc.gov/flu/about/disease.htm
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Streptococcus pneumoniae

• Gram-positive bacteria
• 90 known serotypes
• Polysaccharide capsule important virulence factor
• Type-specific antibody is protective

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Pneumococcal Pneumonia

• Estimated 175,000 hospitalized cases per year
• Up to 36 of adult community-acquired pneumonia
  and 50 of hospital-acquired pneumonia
• Common bacterial complication of influenza and
  measles
• Case-fatality rate 5-7, higher in elderly

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Pneumococcal Bacteremia

• More than 50,000 cases per year in the United
  States
• Rates higher among elderly and very young infants
• Case fatality rate 20 up to 60 among the
  elderly

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Pneumococcal Meningitis

• Estimated 3,000 - 6,000 cases per year in the
  United States
• Case-fatality rate 30, up to 80 in the elderly
• Neurologic sequelae common among survivors

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Penicillin Resistance S. pneumoniae in the
United States
40
35
30
25
Percent
20
15
10
5
0
1979-87
1988-89
1990-91
1992-93
1994-95
1997-98
1999-00
2001-02
5589 487 524 799
1527 1601 1531
1940 35 15 17
19 30 34
33 45
1980s
1990s
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Influenza vaccines

• Inactivated subunit (TIV)
• Trivalent inactivated influenza vaccine
• Intramuscular
• Live attenuated vaccine (LAIV)
• Intranasal
• Trivalent
• Not recommended for persons gt50 years of age
• Not recommended in settings with
  immunocompromised patients

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2006-2007 Vaccine Supply

• Projected 110 million doses
• 20 increase over 2005-2006 season

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Pneumococcal Vaccines

• 1977 14-valent polysaccharide vaccine
  licensed
• 1983 23-valent polysaccharide vaccine
  licensed
• 2000 7-valent polysaccharide conjugate
  vaccine licensed

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Pneumococcal Polysaccharide Vaccine

• Purified capsular polysaccharide antigen from 23
  types of pneumococcus
• Account for 88 of bacteremic pneumococcal
  disease
• Cross-react with types causing additional 8 of
  disease

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Pneumococcal Polysaccharide Vaccine

• Not effective in children lt2 years
• 60-70 against invasive disease
• Less effective in preventing pneumococcal
  pneumonia

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Do the vaccines work? Myth Vaccines Dont Work
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Benefits of Flu Shots in the ElderlyPooled
Estimates Over 6 Seasons
Data from MN HMO, 1990-91 thru 1995-96. Nichol
KL. Arch Intern Med 1998 158 1769.
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Influenza VaccinationReductions in
Hospitalization and Death
16
19
23
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48
2 yr study of elderly members of 3 HMOs -
1998-99 1999-00 seasons with gt 140,000 persons
in each years cohort Nichol KL, et al. N Engl J
Med. 20033481322-1332.
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Percent of Deaths Prevented
Manitoba 1982-83
1985-86
United Kingdom 1989-90
Minnesota 1990-91
1991-92 1992-93 1993-94 1994-95 1995-96
-100
-80
-60
-40
-20
0
20
40
60
80
100
Prevented Fraction ()
Nichol. Vaccine. 199917S47-S52.
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Benefits of Pneumococcal Vaccinations
1 Sisk J. JAMA 1997 278 1333. 2 Nichol KL. Arch
Intern Med 1999 159 2437.
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Effectiveness of Pneumococcal Vaccination in
Older Adults The VSD Cohort Study

• 3 year cohort study of 47,365 members of Group
  Health Coop (Seattle)
• PPV was associated with lower rates of
  bacteremia
• HR 0.56 (95 CI 0.33 0.93)
• PPV was not associated with lower rates of
  community acquired pneumonia
• HR 1.07 (95 CI 0.99 1.14)

HR hazard ratio. Jackson LA, et al. NEJM
2003 348 1747.
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Pneumococcal vaccination did not alter the risk
of hospitalisation from pneumonia .or overall
pneumonia, but the vaccine was associated with
considerable reductions of death risk from
pneumonia (HR 0.28 95 CI 0.090.83).
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Prior vaccination against pneumococcus is
associated with improved survival, decreased
chance of respiratory failure or other
complications, and decreased length of stay among
hospitalized patients with community-acquired
pneumonia. These observations reinforce current
efforts to improve compliance with existing
pneumococcal vaccination recommendations for
adults. Clin Infect Dis. 2006 421093101
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A 55 year old male diabetic is transferred from a
rural hospital emergency department with
respiratory failure and hypotension
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Is Vaccination Safe? Myth Vaccination is Not
Safe (vaccination can make me sick)
Serious vaccine-related side effects (including
those due to revaccination) are EXCEEDINGLY RARE!
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Missed OpportunitiesMyth Vaccination is Not Safe

• Many hospital and emergency department-based
  vaccination programs have been safely and
  effectively implemented with no evidence of
  significant risk

Klein RS, et al. Arch Intern Med.
19831431878-1881. (hospital pneumococcal
vaccine) Magnussen CR, et al. Arch Intern Med.
19841441755-1757. (hospital and ambulatory
pneumococcal vaccine) Bloom HG, et al. J Am
Geriat Soc. 198836897-901. (hospital influenza
and pneumococcal vaccines) Crouse BJ, et al. J
Fam Pract. 199438258-261. (hospital-based
influenza vaccination) Nichol KL, et al. Am J
Med. 1998105385-392. (10-year experience with
inpatient influenza and pneumococcal
vaccination) Rodriquez RM, et al. Ann Emerg Med.
1993221729-1732. (ER-based influenza and
pneumococcal vaccination) Slobodkin D, et al.
Vaccine. 1998161795-1802. (Inner-city ER-based
influenza and pneumococcal vaccination)
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Missed OpportunitiesVaccine Side Effects
Margolis KL, Nichol KL, Poland GA, Pluhar RE.
Frequency of adverse reactions to influenza
vaccine in the elderly. A randomized,
placebo-controlled trial. JAMA.
19902641139-1141.
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Missed OpportunitiesVaccine Side Effects
Nichol KL, Mac Donald R, Hauge M. Side effects
associated with pneumococcal vaccination. Am J
Infect Control. 199725223-228.
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Seasonality of Respiratory Agents Proportion
Isolated in Each Calendar Month During 6 Years of
Tecumseh Study (Michigan)
30 25 20 15 10 5 0
Rhinovirus
Parainfluenza viruses
Percent
30 25 20 15 10 5 0
Respiratory syncytial virus (RSV)
Influenza virus
Percent
Jul
Aug
Sep
Oct
Nov
Dec
Jan
Feb
Mar
Apr
May
Jun
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Vaccination Reality in the USThe Why..

• Despite the fact that influenza and pneumococcal
  vaccines are
• clinically effective
• cost effective
• safe, and
• free to most elderly patients

They are under-utilized!
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Influenza and Pneumococcal Vaccination Rates
Remain Low
2010 Goal
Percent Vaccinated
CDC. MMWR. 2005541-40. http//www.cdc.gov/flu/p
rofessionals/vaccination/coveragelevels.htm.
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Where Should We Vaccinate?

• Anywhere that we find chronically ill or
  elderly patients!

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Tulsa World, The WRITE STUFF Letters from our
readers. November 15, 2006
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Systems-based StrategiesInstitutional Vaccination

• Strategies to improve vaccination rates
• Organizational change
• Provider reminders
• Patient financial incentives
• Provider financial incentives
• Patient reminders
• Provider education
• Patient education
• Assessment and feedback

RAND. Evidence Report and Evidence-based
Recommendations Interventions that increase
utilization of Medicare-funded Preventive
Services for Persons Age 65 and Older. US Dept of
Health and Human Services. Health Care Financing
Administration. Contract No. 500-98-0281.
September 30, 1998. Task Force on Community
Preventive Services. Guide to Community
Preventive Services. Am J Prev Med.
200018(1S)S97-140.
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Standing Orders Programs

• Standing orders programs authorize nurses or
  pharmacists to administer vaccinations according
  to an institution- or physician-approved protocol
  without a physicians examination

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Standing Orders are Among the Most Effective
Strategies

• Non-physicians offer and administer vaccinations
  without direct doctor involvement at the time of
  the visit
• Established through approved policies protocols
• Locations clinics, hospitals nursing homes

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Institutional VaccinationConditions of
Participation

• Federal Register, Vol. 67, No. 191 (October 2,
  2002)
• All orders for drugs and biologicals must be
  in writing and signed by the practitioner or
  practitioners responsible for the care of the
  patient as specified under 482.12(c) with the
  exception of influenza and pneumococcal
  polysaccharide vaccines, which may be
  administered per physician-approved facility
  policy after an assessment for contraindications.
  
• Includes similar provisions for nursing homes and
  home health agencies

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Opportunities for Cross-setting Initiatives

• Physician offices
• Hospitals and home health agencies
• Nursing homes and home health agencies
• Public health agencies
• Mass vaccinators

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Annual influenza vaccination is recommended for
all persons who work in any medical care facility
or provide care in any setting to persons at
increased risk of influenza or complications of
influenza.
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Healthcare Worker Vaccination

• Rates of healthcare worker vaccination are
  unacceptably low
• Now well known to be a patient safety factor
• Healthcare worker vaccination in a pandemic would
  be essential
• Current policies of voluntary vaccination are NOT
  working

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Pandemic InfluenzaRecollections and Predictions

• Dale W. Bratzler, DO, MPH
• QIOSC Medical Director
• Oklahoma Foundation for Medical Quality

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• As their lungs filled with rales the patients
  became short of breath and increasingly cyanotic.
  After gasping for several hours they became
  delirious and incontinent, and many died
  struggling to clear their airways of a
  blood-tinged froth that sometimes gushed from
  their nose and mouth. It was a dreadful
  business.
• Isaac Starr, MD
• Ann Intern Med. 2006145138-140.

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• The deaths in the hospital as a whole exceeded
  25 per night during the peak of the epidemic.

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The Influenza Pandemic of 1918-1919

• 25-30 of worlds population (500 million
  people) fell ill
• gt40 million deaths worldwide 60 in people ages
  20-45
• gt500,000 deaths in United States 196,000 in
  October, 1918 alone

Heinig R. The Flu Pandemic. New York Times
Magazine. November 29, 1992.
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Emergency hospital, 1918 flu epidemic, Camp
Funston, Kansas Courtesy of National Museum of
Health and Medicine, Armed Forces Institute of
Pathology
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The massive mortality due to the influenza
epidemic in October of 1918 in Kansas. This is
representative of what happened in every state in
the nation.
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US Life Expectancy1900-1990
Age (y)
Year
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Influenza Mortality
Jeffery K. Taubenberger, Department of Molecular
Pathology, Armed Forces Institute of Pathology,
1413 Research Blvd, Bldg 101, Rm 1057, Rockville,
MD 20850-3125, USA
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Excess Mortality due to Influenza1918 Pandemic
Age groupspecific annual excess mortality due to
pneumonia and influenza during the influenza
pandemic in 1918. The average annual excess
mortality for the period of 19131917 was used as
the baseline.
Clin Infect Dis. 2001 3313758.
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Nations with Confirmed Cases H5N1 Avian
Influenza (May 19, 2006)
http//pandemicflu.gov/
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Avian H5N1 Swelling of the head and face in an
affected bird
http//www.aphis.usda.gov/vs/birdbiosecurity/photo
s.html
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Avian H5N1Purple discoloration of the comb in
the affected bird
http//www.aphis.usda.gov/vs/birdbiosecurity/photo
s.html
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H5N1 Emerges in Humans

• Highly pathogenic H5N1 poultry outbreaks
• Markets and farms
• 1.4 million poultry culled, markets disinfected
• Poultry imports temporarily stopped from China
• H5N1 (Hong Kong, 1997)
• 18 confirmed cases, 6 deaths (all ages)
• Median age 9.5 years (range 1-60 yrs.) 11
  pneumonia cases
• Risk factor visiting live poultry market the
  week before illness
• No evidence for efficient or sustained
  human-to-human transmission of H5N1 viruses No
  pandemic

Chan P et al. Clin Infect Dis. 200234(Suppl
2)S58-S64. Mounts A et al. J Infect Dis.
1999180505-508. Buxton Bridges C et al. J
Infect Dis. 2000181344-348.
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Human H5N1 Cases2003-06

• Most cases infrequent, sporadic avian-to-human
  transmission
• Previously healthy children, young adults
• Direct contact with sick/dead poultry
• Few cases consumed uncooked duck blood
• Some clustering of cases
• Probable 3-person chain of transmission (2
  generations of transmission) within an Indonesian
  family

http//www.who.int/csr/don/2006_06_20/en/index.htm
l
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Potential for a Pandemic

• To cause a global influenza pandemic, the virus
  needs three properties
• Ability to infect people
• Substantial antigenic novelty naiveté
• Efficient person-to-person transmission

H5N1 has this characteristic
Bartlett JG, Hayden FG. Ann Intern Med.
2005143460-3.
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Potential for Pandemic

• Outbreaks of influenza in animals, especially
  when happening simultaneously with annual
  outbreaks in humans, increase the chances of a
  pandemic, through the merging of animal and human
  influenza viruses.
• During the last few years, the world has faced
  several threats with pandemic potential, making
  the occurrence of the next pandemic just a matter
  of time.

Pigs, poultry and people.
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Mortality in Human Cases of H5N1

• Mortality rate is approximately 50 in reported
  cases
• Most deaths have occurred in young, previously
  healthy adults or children
• Autopsies have shown a hemorrhagic, necrotizing
  pneumonia similar to that seen with the Spanish
  flu

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Chest Radiographs
Hien T et al. N Engl J Med 20043501179-1188
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Estimates in Moderate and Severe Pandemic
Influenza Scenarios
Estimates based on extrapolation from past
pandemics in the United States. Estimates do not
include the potential impact of interventions not
available during 20th century pandemics.
Data from US National Vaccine Program Office
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Could H5N1 Cause a Pandemic?
Interpandemic
Pandemic
Pandemic alert
Phase 4
Larger clusters, localized Limited spread
among humans
Phase 1
Phase 2
Phase 3
Phase 5
Phase 6
No new virus in humans Animal viruses low risk to
humans
No new virus in humans Animal viruses high risk
to humans
New virus in humans Little/no spread among humans
Small clusters, localized Limited spread among
humans
Increased and sustained spread in general human
population
Current status of H5N1
WHO Global Influenza Preparedness Plan, 2005.
Available at http//www.who.int/csr/resources/pub
lications/influenza/GIP_2005_5Eweb.pdf
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• Seasonal and pandemic influenza are inseparable

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Epidemic Influenza Has a Substantial Impact
Average respiratory circulatory 294,000
(1979-80 through 2000-01) Average all cause
(1976-77 through 1998-99) Average all cause
(1990-91 through 1998-99)
Adapted from CDC. MMWR Recomm Rep. 200554
(RR-8)1-40. Thompson W et al. JAMA.
2003289179-186. Thompson W et al. JAMA.
20042921333-1340. Adams P et al. Vital Health
Stat. 1999101-203.
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US Seasonal Influenza VaccineProduction and Use
Vaccine is wasted every year!
Data from US National Vaccine Program Office
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Seasonal Influenza Vaccines and Prevention
Summary

• Influenza remains the leading cause of vaccine
  preventable adult mortality
• Seasonal influenza is associated with substantial
  morbidity and mortality in all age groups
• Current trivalent inactivated and live attenuated
  vaccines are safe and effective for children,
  adults, and elders
• Influenza vaccines are cost saving or cost
  effective in children, working adults, and elders
• Influenza and pneumonia vaccine coverage is far
  below societal goals

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Healthcare Worker Vaccination

• Rates of healthcare worker vaccination are
  unacceptably low
• Now well known to be a patient safety factor
• Healthcare worker vaccination in a pandemic would
  be essential
• Current policies of voluntary vaccination are NOT
  working

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700 AM
830 PM
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Deaths Due to Vaccine Preventable Diseases - US,
1989-1998
630k (90 in elderly)
11k (reported cases though the actual number is
likely 5-10 times higher)
VPD vaccine preventable diseases. MMWR 2001 48
(RR-53) Thompson et al. JAMA 2003 289 179
Feikin DR, et al. Am J Public Health 2000 90
223-9.
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Effect of Travel and Missed Cases on the SARS
Epidemic Spread from Hotel M, Hong Kong
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Summary

• Vaccination rates for our most vulnerable are
  unacceptably low
• Vaccination in these settings is effective and IS
  the standard of care!
• Systems-based interventions are the best way to
  improve vaccination rates

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Summary (cont.)

• It is not a question of whether there will be
  another pandemic, it is a question of when and
  how severe
• While it is unlikely that we will, in the short
  term, be able to prevent another pandemic,
  perhaps we can contain and minimize the impact