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PREPAREDNESS FOR AN INFLUENZA PANDEMIC: FOCUS ON VACCINE DEVELOPMENT AND UNC HOSPITALS PREPAREDNESS

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Title: PREPAREDNESS FOR AN INFLUENZA PANDEMIC: FOCUS ON VACCINE DEVELOPMENT AND UNC HOSPITALS PREPAREDNESS


1
PREPAREDNESS FOR AN INFLUENZA PANDEMIC FOCUS ON
VACCINE DEVELOPMENT AND UNC HOSPITALS
PREPAREDNESS
  • David Jay Weber, M.D., M.P.H.
  • Professor of Medicine, Pediatrics Epidemiology
  • Medical Director, Hospital Epidemiology and
    Occupational Health
  • University of North Carolina at Chapel Hill

2
SOURCE OF SLIDES
  • Robert Belshe, Washington University
  • Nancy Cox, CDC
  • Jeffrey Engel, NC Health Department
  • James Matthews, Sanofi Pasteur
  • Andrew Pavia, University of Utah
  • Bill Schaffner, Vanderbilt
  • David Shay, CDC
  • Jay Steinberg, Emory

3
INFLUENZA PRIMER
4
Influenza Disease Burden to U.S. Societyin an
Average Year
Deaths 25,000 - 72,000
Hospitalizations 114,000 - 257,500
Physician visits 25 million
Infections and illnesses 50 - 60 million
Thompson WW et al. JAMA. 2003289179-86. Couch
RB. Ann Intern Med. 2000133992-8. Patriarca PA.
JAMA. 199928275-7. ACIP. MMWR.
200453(RR06)1-40.
5
INFLUENZA BIOLOGY IMPACT
  • Single-stranded, enveloped, RNA virus
    (orthomyxoviridae family)
  • Influenza A
  • Potentially severe illness epidemic and
    pandemics
  • Rapidly changing
  • Influenza B
  • Usually less severe illness may cause epidemics
  • More uniform
  • Influenza C
  • Usually mild or asymptomatic illness

6
INFLUENZA BIOLOGY IMPACT
  • Impact
  • 25-50 million people contract influenza annually
    (attack rate of 10-20)
  • 226,000 hospitalizations per year
  • 36,000 deaths per year
  • Cost 1 to 3 billion dollars per year
  • Causes respiratory tract disease
  • Sudden onset
  • More severe pneumonia during pregnancy
  • No carrier state (but inapparent illness may
    occur)

7
Influenza Activity Can Peak From December
Through May
Month of peak influenza activity during influenza
seasons in the United States, 19762002
11
6
4
3
1
1
www.cdc.gov/nip/publications/pink/flu.pdf.
8
Structure of the Influenza Virus
Hemagglutinin (HA)
Neuraminidase (NA)
M2
Nucleoprotein (NP)
M1
Polymerase (P) Proteins
Adapted from Hayden FG et al. Clin Virol.
1997911-42.
9
Viral Nomenclature
Type of Nuclear Material
Hemagglutinin
Neuraminidase
A / Sydney / 184 / 93 (H3N2)
Virus subtype
Virus type
Geographic origin
Year of isolation
Strain number
CDC. Atkinson W, et al. Chapter 13 Influenza.
In Epidemiology and Prevention of
Vaccine-Preventable Diseases, 4th ed. Department
of Health and Human Services, Public Health
Service, 1998, 220
10
Timeline of Emergence of Influenza A Viruses
in Humans
Avian Influenza
H7
H9
H5
Russian Influenza
H5
H1
Asian Influenza
H3
Spanish Influenza
H2
Hong Kong Influenza
H1
1918
1957
1968
1977
1997
2003
1998/9
11
Antigenic Drift
12
Antigenic Shift
13
Why the Concern? During the past 100 years,
there have been three major pandemics, and there
are strong signals in recent years of pandemic
potential (epizootics of avian flu)
H5N1
H7N7
H5N1
H9N2
H5N1
H1N1
H3N2
Different Viruses Migratory Birds Domestic Poultry
H2N2
DIFFERENT VIRUSES Migratory Birds Domestic Poultry
H1N1
2003
1968
1957
1918
2004/5
1977
1997
1999
1918
1918
50 - 100 millions
1 million
800 000
?
Mortality
Asian Flu
Hong Kong Flu
Spanish flu
1950
1925
1975
2000
14
Antigenic Change - Shift
15
INFLUENA PANDEMICS IN THE 20th CENTURY
HHS Pandemic Influenza Plan, October 2005
16
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17
Americas deaths from influenza were greater than
the number of U.S. servicemen killed in any war
Thousands
Civil WWI 1918-19 WWII
Korean Vietnam War
Influenza War War

18
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19
Worldwide Spread in 6 Months Spread of H2N2
Influenza in 1957 Asian Flu
Feb-Mar 1957Apr-May 1957Jun-Jul-Aug 1957
68,000 deaths, US
20
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21
INFLUENZA ANTIVIRAL THERAPIES
  • Amantadine Influenza A
  • Treatment and prophylaxis dose adjust in renal
    failure
  • Rimantadine Influenza A
  • Treatment and prophylaxis dose adjust in renal
    and hepatic failure
  • Oseltamivir Tamiflu Influenza A B
  • Treatment (5 days) and prophylaxis (PEP 7 days
    Seasonal 42 days) dose adjust in renal failure
  • Zanamivir Relenza Influenza A B
  • Treatment only
  • Must begin therapy within 2 days of onset of
    illness

22
Antiviral Agents for Treatment
Modified from Couch RB, Ann Intern Med.
2000133992-998
23
Antiviral Agents for Prophylaxis
Not FDA approved
Modified from Couch RB, Ann Intern Med.
2000133992-998
24
Moscona, A. N Engl J Med 20053531363-1373
25
INFLUENZA - ANTIVIRAL THERAPIESTOXICITIES
  • Amantadine and rimantadine
  • CNS (anxiety, insomnia, seizures,
    hallucinations), GI
  • CNS toxicity greater in patients on amantadine
  • Resistance develops in 10-30 during treatment
    course
  • Teratogenic and embryogenic in animals
  • Zanamivir
  • Brochospasm (avoid in asthmatics)
  • Oseltamivir
  • GI (nausea and/or vomiting 5-10)

26
ANTIVIRAL THERAPY OF INFLUENZA
? No placebo-controlled study or not reported
Source Andrew Pavia, Pandemic Influenza
Planning, Emory, Nov. 2005
27
ANTIVIRAL RESISTANT INFLUENZA DURING TREATMENT
Roberts N. Trans R Roc Lond 20013561895 Kiao,
et al. Lancet 2004364750
28
OSELTAMIVIR EFFICACY
29
Tamiflu (oseltamivir phosphate) Seasonal
Prophylaxis in a Vaccinated Frail Elderly
Population Results
of patients with laboratory-confirmed clinical
influenza
Data on file (Ref. 155-027). Hoffmann-La Roche
Inc.
30
OSELTAMIVIR IMPACT ON LOWER RESIRATORY TRACT
COMPLICATIONS (LRTC)
  • Analysis of prospective data from patients
    enrolled in 10 placebo controlled trials (N3564)
  • Results confirmed influenza (oseltamivir vs
    placebo)
  • Reduced overall antibiotic use 14.0 vs 19.1
    (p
  • Reduced LRTCs-associated antibiotic use 4.6 vs
    10.3 (p
  • Reduced LRTCs leading to antibiotics in high risk
    patients 12.2 vs 18.5 (p0.02)
  • Reduce overall hospitalizations 1.0 vs 1.7
    (p0.02)
  • Unconfirmed influenza No difference in
    incidence of LRTC, overall antibiotic use or
    hospitalizations

31
Day of onset of antibiotic therapy for lower
respiratory tract complications in oseltamivir
(75 mg twice daily) and placebo recipients with
influenza infection
Kaiser, L. et al. Arch Intern Med
20031631667-1672.
32
Day of hospitalization among placebo- or
oseltamivir (75 mg twice daily) - treated adults
with influenza infection
Kaiser, L. et al. Arch Intern Med
20031631667-1672.
33
ANTIVIRALS FOR CHEMOPROPHYLAXIS CDC
RECOMMENDATIONS
  • Community outbreak (usual duration 6-8 weeks)
  • Persons at high risk of serious complications
  • Persons at high risk of serious complications
    following vaccination until immunity develops (2
    weeks for adults, 6 weeks for first time
    pediatric vaccinees)
  • Persons who are not expected to mount a
    sufficient immune response due to
    immunosuppression
  • Healthcare workers with direct patient care
    responsibilities unable to obtain vaccine

34
AVIAN INFLUENZA
35
PANDEMIC INFLUENZA PLANNING CHALLENGES
  • Worldwide distribution
  • Simultaneous appearance in multiple
    states/locales
  • Long duration (2 years)
  • Surge capacity Medications, ventilators,
    hospital beds, personnel
  • Personnel Exhaustion, concerns about infection
  • Inadequate antivirals and distribution/allocation
  • Vaccine development and distribution/allocation
  • Maintaining infrastructure
  • Maintaining quarantine

36
CHARACTERISTICS OF AN INFLUENZA PANDEMIC
  • The ability of the virus to spread worldwide
  • Simultaneous outbreaks throughout the US,
    limiting the ability of an jurisdiction to
    provide assistance to other areas
  • The fact that many people may be asymptomatic
    while infectious
  • Enormous demands on the healthcare system
  • Delays and shortages in the availability of
    vaccines and antivirals
  • Potential disruption of national and community
    infrastructures including transportation,
    commerce, utilities and public safety due to
    illness and death among workers and their
    families
  • Duration 2 years

37
AVIAN INFLUENZA EPIDEMIOLOGY
38
Current Influenza A/H3N2 is Partly Derived from
the 1918 Virus
Taubenberger et al, Nature, Oct 2005
39
Defining a Pandemic WHO Phases
  • Phase 1. No new influenza virus subtypes detected
    in humans. If animals are infected, risk to
    humans is low.
  • Phase 2. No new influenza virus subtypes detected
    in humans. However, a circulating animal
    influenza virus subtype poses a substantial risk
    of human disease.
  • Phase 3. Isolated human infections, no
    human-to-human spread except rare close contacts.
  • Phase 4. Small, highly localized cluster(s),
    limited human-to-human transmission.
  • Phase 5. Larger localized cluster(s) limited
    human-to-human spread. Substantial pandemic
    risk.
  • Phase 6. Pandemic phase Sustained transmission
    among humans occurs.

40
AVIAN INFLUENZA EPIDEMIOLOGY
  • Multiple outbreaks of H5N1 in Asia since 1997
  • Recently animal evidence of H5N1 infection (duck
    strain)
  • Pigs serologic/culture in china (ProMed)
  • Cats experimental infection (Kuiken. Science,
    2004 9/02)

41
AVIAN INFLUENZA EPIDEMIOLOGY
  • Human-to-human cases reported
  • Retrospective serologic evidence 1997
  • Outbreak (Chan CID)
  • 3.7 healthcare workers
  • 6/51 household contacts
  • Possible one family cluster (N2) in current
    Thailand outbreak
  • Requires close contact, inefficient transmission

42
AVIAN INFLUENZA
  • Treatment
  • Neuraminidase inhibitors
  • Oseltamivir (Tamiflu)
  • Zanamivir (Inhaled)
  • Current H5N1 Amantadine and Rimantadine Resistant
  • For influenza clinical activity only if given in
    1st 48 hours
  • Likely would also work for chemoprophylaxis
  • Eradication
  • Large scale culling of birds

43
Some Avian-to-Human Influenza Transmissions
44
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45
H5N1 SNAPSHOT NOVEMBER 2005
  • 124 human cases, 63 deaths (50)
  • N5H1 strains now present in 17 countries
  • Virus spreading beyond the original geographic
    region to mainland China, Philippines, Siberia,
    Indonesia, Malayasia, Turkey (5 new countries
    since July)
  • 150 million birds culled (cost 10 billion)

46
FACTORS LEADING TO CONCERN OF AN H5N1 INFLUENZA
PANDEMIC
  • Avian H5N1 is widespread and endemic in Asia with
    spread to Russia and Europe
  • Avian H5N1 is becoming more deadly in a growing
    number of bird and mammals species
  • Wild birds and domestic ducks may be
    asymptomatically infected
  • The virus is able to transmit directly from birds
    to some mammals and in some circumstances to
    people
  • Sporadic spread directly from animals to humans
    suspected human-to-human transmission in rare
    instances
  • Genetic studies demonstrated ongoing evolution of
    H5N1

47
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48
AVIAN INFLUENA PREPAREDNESS
49
PANDEMIC INFLUENZA IMPACT, US
HHS Pandemic Influenza Plan, October 2005
50
PANDEMIC INFLUENZA IMPACT, NC
Assumes a 25 attack rate NC Pandemic Influenza
Plan, October 2005
51
AVIAN INFLUENZA IMPACT, NC
  • Number of cases 1,856,296
  • Hospitalizations 65,637
  • Deaths 14,987
  • Assumptions strain 3x more lethal than 1968-69
    Hong Kong influenza
  • Source USA Today, 11 October 2005

52
NATIONAL PROBLEMS(Not Under Control of Hospital)
  • General issues
  • Lack of surge capacity (ICU beds, ventilators,
    floor beds)
  • Nursing shortage
  • Just in time delivery of goods
  • Response to avian influenza
  • Inadequate supply of PPE
  • Inadequate supply of antivirals
  • Lack of effective vaccine for avian influenza
  • Public hysteria

53
NATIONAL PROBLEMS(Not Under Control of Hospital)
  • Other issues
  • No defined CDC isolation category for isolation
    of highly communicable diseases (i.e., diseases
    for whom airborne with eye protection
    recommended) Avian influenza, SARS, certain
    viral hemorrhagic fevers

54
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55
AVIAN INFLUENZA ANTIVIRALS
  • IDSA RECOMMENDATIONS

56
Recommendations - Priority groups
  • 1. Hospitalized patients with influenza
  • 2. HCWs and EMS workers with direct patient
    contact
  • 3. Highest risk outpatients
  • 4. Pandemic health responders, public safety
    key government decision makers
  • 5. Other high risk outpatients
  • 6. Outbreak response (eg PEP in nursing homes)
  • 7. Prophylaxis HCWs in ER, ICU, EMS, dialysis
  • 8. Pandemic societal responders other HCWs
  • 9. Other outpatients
  • 1O. Prophylaxis for highest risk outpatients
  • 11. Prophylaxis for other HCWs w/ patient contact

57
Proposed Priority Target Groups
58
Estimated Pandemic Mortality, UK, 1918-19
Gani et al. Emerging Infect Dis 111355, 2005
59
EFFICACY OF OSELTAMIVIR IN A MOUSE MODEL
(A/Vietnam/1203/04 H5N1)
Yen H-L, et al. JID 2005192665
60
ANTIVIRALS
  • Demand
  • 40 million courses minimum needed to support
    critical pandemic responses
  • 133 million courses minimum to treat all
    infected and provide prophylaxis for critical
    personnel
  • Supply
  • 4 million courses in US National Stockpile
  • Current stockpile based on used drugs for
    treatment (more needed to provide prophylaxis)
  • Mouse model suggests need to treat for 8 days
    rather than 5 days

61
AVIAN INFLUENZA VACCINES
62
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63
VACCINE BY THE NUMBERS
  • 40 million estimated number of deaths worldwide
    for 1918 pandemic
  • 6.2 billion worlds population
  • 300 million doses worldwide capacity for
    trivalent influenza vaccine
  • 900 million doses worldwide capacity for
    monovalent vaccine (issues include yield,
    adjuvant, process used, antigen content
  • 1 or 2 doses?
  • /- 2 years expected duration of pandemic
  • /- 6 months time from recognition of pandemic
    till vaccine available
  • 9 countries number of countries with vaccine
    capacity (70 in EU)
  • 3-5 million doses/week (15 ?g) current capacity
    of US manufacturers

64
Selected US Regulatory Issues Regarding a
Pandemic Antigenic Strain in Approved Vaccines
  • Pandemic vaccine likely would be approved under
    existing regulations for updating strains in
    currently approved vaccines
  • WHO recommended pandemic strain could be
    substituted into a monovalent preparation
  • Updating strains to monovalent, pandemic type
    would be less burdened than approval of novel
    vaccines
  • Issues of antigen quantity and number of doses
    might require clinical trials

Wood Levandowski, Vaccine 211786-88, 2003
65
Generalized Influenza Vaccine Global Production
Timetable (NH - Representative Year)
Egg supply organization
Egg supply for production
Seed lots
Monovalent batches
Formulation
Filling / Packaging
Packaging documentation
Ref Member State Release
Pharmaceutical file
MA
Clinical trial
Vaccine Delivery
WHO meeting D0 mid Feb
D0
Reagent availabilityEnd of May
Mid May
July/August
D0 - 6 months
66
Vaccine Development
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
WHO/CDC)
WHO/CDC/FDA
CDC/FDA
FDA
FDA
FDA
manufacturers
clinic
67
Sources of Information on Pandemic Influenza A
Vaccines
  • Studies of contemporary, novel egg grown HA in
    adults, (e.g., H9 and H5)
  • Studies of H2 in naïve subjects after 1968
  • Studies of Swine Flu vaccine in 1976 or H1N1 in
    younger adults in 1977
  • Studies of TIV or LAIV in seronegative children

68
Characteristics of Influenza Vaccines in Naïve
Subjects
  • Different HAs exhibit different immunogenicity
  • Two or three doses of HA required
  • Adjuvants may reduce the number of doses of HA
    needed
  • High doses of HA or adjuvant may broaden the
    immune responses
  • LAIV single dose immunogenic, induces broad
    immune responses
  • Unexpected interactions may occur (e.g. H2 and
    H9)

69
Experiences with Pandemic Vaccines
  • A/USSR/92/77 (H1N1) - Immunogenicity studies
    compared results in younger persons (born after
    1957, naïve to H1) to older persons (born before
    1957, likely previously infected with H1)
  • Large doses of vaccine, 60?g HA required for one
    dose to be immunogenic
  • Two doses of 5?g was immunogenic
  • Whole virus vaccines more immunogenic than split
    virus, but whole virus vaccine was more
    reactogenic
  • Adjuvants can enhance the immune responses and be
    dose sparing in unprimed persons

70
Breadth of Antibody Responses to H5N3 Vaccine
(A/Duck/Singapore/97)
Vaccine 30?g egg grown HA with ( ) or
without ( ) MF59 adjuvant, 3 doses,
neutralizing Ab
Stephenson et al, JID 1911210-1215, 2005
NEUT Ab
Three doses of adjuvanted influenza vaccine
produced with a 1997 avian strain can prime and
induce antibodies against H5N1 strains isolated
in 2003 and 2004
71
Clinical Trials with Egg Grown HA-H5 Vaccine
  • Healthy adults age 18-40 (J.Treanor, PI)
  • Dose response study
  • Compare placebo, 7.5µg, 15µg, 45µg or 90µg
  • Vaccine given at times 0, 1 month
  • Study completed, data pending, but HHS reports 2
    doses of 90 mcg was immunogenic
  • Booster planned
  • Healthy Children, Age 2-9, to begin soon
  • Elderly, Age ?65, to begin soon

72
Neutralizing Antibody Response to Two Doses of
rHA0 (H5) to A/HK/156/97 H5N1
with neut. response
45 ?g x2
Placebo
90 ?g x2
25 ?g x2
Treanor et al, Vaccine 191732-37, 2001
73
Clinical Trials of Vaccines Designed for Pandemic
Influenza, Other Ongoing and Future Trials
74
LAIV Induces Broad Immune Responses
Belshe et al, Peds ID, 2000
75
H9/AA ca Live Virus Vaccine Provides Complete
Protection from Replication of Homologous and
Heterologous H9N2 Challenge Viruses in the A
(upper) and B (lower) Respiratory Tract in Mice
(A)
Virus titer (log10 TCID50/ml)
H9 Challenge Virus
1073 Immunizing Virus
(B)
Virus titer (log10 TCID50/ml)
Chen et al, Vaccine, 2003
H9 Challenge Virus
1073 Immunizing Virus
76
Conclusions
  • Hemagglutinins have different properties, several
    need to be studied
  • 2 or 3 doses and high doses of purified HA will
    be needed to induce antibodies to novel HAs
  • Strain variation will remain a significant
    problem i.e. difficult to predict which vaccine
    to stockpile
  • Developing vaccines to mimic priming by natural
    infection is important
  • LAIV
  • Adjuvanted HA subunit or rHA0
  • Novel vaccines need to be developed
  • Novel methods of production (I.e., cell culture
    need to be commercialized)

77
VACCINE RESPONSE
  • Presidents proposed plan 7.1 billion
  • Produce and stockpile H5N1 vaccine
  • Develop cell culture systems for vaccine
    development
  • HHS pandemic influenza plan
  • Ensure domestic production capable of producing
    vaccine within 6 mo
  • Stockpile oseltamivir
  • NC State plan
  • Responsible for distribution/allocation of
    antivirals and vaccines

78
NVAC/ACIP ALLOCATION PRIORITIES 1A
  • Priority Groups
  • Vaccine and antiviral manufacturers and others
    essential to manufacturing and critical support
    (40,000)
  • Medical workers and public health workers who are
    involved in direct patient contact, other support
    services essential for direct patient care, and
    vaccinators (8-9 million)
  • Rationale
  • Need to assure maximum production of vaccine and
    antiviral drugs
  • Healthcare workers are required for quality
    medical care (studies show outcome is associated
    with staff-to-patient ratios). There is little
    surge capacity among healthcare sector personnel
    to meet increased demand

79
NVAC/ACIP ALLOCATION PRIORITIES 1B
  • Priority Groups
  • Persons 65 years with 1 or more influenza
    high-risk conditions, not including essential
    hypertension (18.2 million)
  • Persons 6 mo - 64 years with 2 or more influenza
    high-risk conditions, not including essential
    hypertension (6.9 million)
  • Persons 6 months or older with history of
    hospitalization for pneumonia or influenza or
    other influenza high-risk condition in the past
    year (740,000)
  • Rationale
  • These groups are at high risk of hospitalization
    and death. Excludes elderly in nursing homes and
    those who are immunocompromised and would not
    likely be protected by vaccination

80
NVAC/ACIP ALLOCATION PRIORITIES 1C
  • Priority Groups
  • Pregnant women (3.0 million)
  • Household contacts of severely immunocompromised
    persons who would not be vaccinated due to likely
    poor response to vaccine (1.95 million with
    transplants, AIDS, and incident cancer x 1.4
    household contacts per person 2.7 million
    persons)
  • Household contacts of children million)
  • Rationale
  • In past pandemics and for annual influenza,
    pregnant women have been at high risk
    vaccination will also protect the infant who
    cannot receive vaccine.
  • Vaccination of household contacts of
    immunocompromised and young infants will decrease
    risk of exposure and infection among those who
    cannot be directly protected by vaccination.

81
NVAC/ACIP ALLOCATION PRIORITIES 1D
  • Priority Groups
  • Public health emergency response workers critical
    to pandemic response (assumed one-third of
    estimated public health workforce 150,000)
  • Key government leaders
  • Rationale
  • Critical to implement pandemic response, such as
    providing vaccinations and managing/monitoring
    response activities
  • Preserving decision-making capacity also critical
    for managing and implementing a response

82
NVAC/ACIP ALLOCATION PRIORITIES 2A
  • Priority Group
  • Healthy 65 years and older (17.7 million)
  • 6 months to 64 years with 1 high-risk condition
    (35.8 million)
  • 6-23 months old, healthy (5.6 million)
  • Rationale
  • Groups that are also at increased risk but not as
    high risk as population in Tier 1B

83
NVAC/ACIP ALLOCATION PRIORITIES 2B
  • Priority Groups
  • Other public health emergency responders
    (300,000)
  • Public safety workers including police, fire, and
    correctional facility staff (2.99 million)
  • Utility workers essential for maintenance of
    power, water, and sewage systems (364,000)
  • Transportation workers transporting fuel, water,
    food, and medical supplies as well as public
    ground public transportation (3.8 mil)
  • Telecommunications/IT for essential network
    operations and maintenance (1.08 million)
  • Rationale
  • Includes critical infrastructure groups that have
    impact on maintaining health (e.g., public safety
    or transportation of medical supplies and food)
    implementing a pandemic response and on
    maintaining societal functions

84
NVAC/ACIP ALLOCATION PRIORITIES 3
  • Priority Groups
  • Other key government health decision-makers
    (estimated number not yet determined)
  • Funeral Directors and embalmers (62,000)
  • Rationale
  • Other important societal groups for a pandemic
    response but of lower priority

85
NVAC/ACIP ALLOCATION PRIORITIES 4
  • Priority Groups
  • Healthy persons 2-64 years not included in above
    categories (179.3 million)
  • Rationale
  • All persons not included in other groups based on
    objective to vaccinate all those who want
    protection

86
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88
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89
LOCAL PREPAREDNESS
90
LESSONS FROM SARS
91
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92
SARS CASES AND OUTCOME
WHO 21 April 2004
93
Total SARS Cases and Healthcare Workers by
Country
HCW
Total No. SARS cases
HCW
94
Time-line NC Confirmed SARS Case, 2003
  • 5/15-18 Visited Toronto
  • 5/19-23 Worked at UNC
  • 5/24 Developed fever (did not work)
  • 5/27, 5/28, 6/1, 6/3 Visited LMD (free standing
    clinic)
  • 5/30 Doxycycline begun for suspected RMSF
  • 6/2 Respiratory symptoms
  • 6/3 CXR with infiltrate SARS suspected, health
    department notified
  • 6/3, 6/9 Serum collected sent to CDC
  • 6/9 Seroconversion to SARS-CoV
  • 2 workplace contacts investigated for atypical
    pneumonia
  • 6/13 Contact 1 diagnosed with mycoplasma 6/13
  • 6/13 Contact 2 dies with pneumonia/ARDS

95
SARS in Toronto, 2003
Orange County mans travel dates
96
Index Case, June 8
97
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98
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99
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100
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101
AIR CONDITIONING
102
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103
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104
SARS CONTROL MEASURES
  • Hospital Infection Control
  • Early detection
  • Containment Proper infection control,
    environmental cleaning
  • Protection of personnel PPE, hand hygiene
  • Community
  • Active Surveillance
  • Disease Investigation
  • Isolation and Quarantine

105
Hospital-based SARS surveillance Options for
Enhanced Surveillance
Facility with no SARS cases
Be alert for clusters of pneumonia among HCWs
Monitor HCWs taking care of SARS patients daily
for fever, cough or SOB
Screen all visitors
Fever, cough, or shortness of breath? SARS Risk
Factors?
Monitor daily healthcare workers
inpatients
Facility with unlinked nosocomial transmission
106
LESSONS FROM SARS
  • Need to nestle response to a highly communicable
    disease in hospital disaster plan
  • Solution Revised disaster plan
  • Concern about being labeled SARS hospital
  • Work with NC State Health Department
  • Must manage worker and public concern (i.e.,
    provide public relations use local/state health
    departments)
  • Improved communication within hospital and with
    health departments
  • Inadequate supplies of PPE
  • 3 months PPE stockpiled by hospital (being
    increased to 6 months)

107
LESSONS FROM SARS
  • Inadequate outpatient facilities to handle highly
    communicable diseases
  • Solution New ID clinic (all rooms meet CDC
    airborne isolation requirements)
  • Need to screen for travel to endemic area at
    entry to hospital or clinic
  • Message on phone while awaiting operator, signs
    at hospital entry
  • Need for UNC Health Care System to have its own
    diagnostic laboratory capacity (i.e., not rely on
    CDC)
  • PCR developed for SARS-coV

108
LESSONS FROM SARS
  • Need for State policy on transport of patients
    with highly communicable diseases
  • Solution Ongoing discussions with State Health
    Department
  • Must manage worker exhaustion
  • Solution enforced rest periods
  • Inability of workers to adhere exactly to
    guidelines for placing and removing PPE
  • Solution PPE monitor

109
LOCAL PREPAREDNESS
110
FEDERAL AND STATE LOCAL PREPAREDNESS
  • HHS pandemic influenza plan
  • Stockpile ventilators and other equipment in
    Strategic National Stockpile
  • Widely available accurate rapid diagnostic tests
  • Assist communities with surge mortuary services
  • Provide psychosocial support to responders

111
AVIAN INFLUENZA IMPACT, NC
  • Number of cases 1,856,296
  • Hospitalizations 65,637
  • Deaths 14,987
  • Assumptions strain 3x more lethal than 1968-69
    Hong Kong influenza
  • Source USA Today, 11 October 2005

112
UNC HOSPITAL PREPAREDNESS
  • Surveillance
  • Influenza like activity (ILI) in NC sentinel
    sites, UNC ED
  • Laboratory tests for influenza (number and
    frequency positive)
  • Diagnosis (detection)
  • Rapid testing available for influenza A B, and
    RSV (24/7)
  • PCR available to diagnosis all influenza A
    strains (unable to differentiate H5N1 strains
    from other influenza A strains)
  • Graded response (i.e., hierarchy of response
    depending on threat)
  • Hospital response plan
  • Modeled on SARS response plan

113
INFLUENZA LIKE ILLNESS ACTIVITY, NC AND UNC ED,
2004-05
114
INFLUENZA TESTS AND RESULTS, UNC, 2004-05
115
UNC HOSPITAL PREPAREDNESS
  • Cooperation with county and state public health
    authorities
  • State response plan
  • Communication pathways established (PHE network,
    SPICE, others)
  • Nestle influenza response in disaster planning
  • Hospital disaster plan
  • Frequent drills
  • Incident command system
  • Access to senior administrators
  • Ad Hoc Committee for vaccine distribution
    (reports to MSEC)

116
UNC HOSPITAL PREPAREDNESS
  • Minimizing exposure
  • Universal respiratory hygiene (signs in
    clinics/ED, method to provide persons with
    symptoms of URI tissues, mask, education)
  • Droplet precautions for persons with URI until
    diagnosis rules out need for isolation
  • Adequate PPE supplies
  • 3 month stockpile of PPE (especially N95
    respirators)
  • Training and institution of special airborne
    isolation
  • Components N95 respiratory, airborne isolation
    room (negative pressure, direct out exhausted
    air), eye protection

117
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118
UNC HOSPITAL PREPAREDNESS
  • Ability to rapidly train large numbers of
    healthcare workers in use of N95
  • Use train the trainers approach
  • Multiple screeners available (NX)
  • Plan for evaluating ill employees with URI
    symptoms
  • Fever plus symptoms Relieve from duty, care per
    LMD
  • Symptoms (work in PICU, NICU, BMTU) Rapid RSV
    and influenza testing (positive test exclusion
    from these units)
  • Symptoms without fever allowed to work while
    wearing mask

119
UNC HOSPITAL PREPAREDNESS
  • Availability of facilities to safely screen
    outpatients for highly communicable diseases
  • Infectious disease clinic 8 clinic rooms, all
    meet airborne isolation requirements (direct out
    exhausted air, negative pressure), separate
    entrance that does not require movement through
    hospital
  • Family Practice center Free standing facility
    with multiple exam rooms, laboratory capacity,
    near main hospital
  • Adequate number of isolation beds
  • Airborne isolation beds available at UNC 75
    (Adult ICU 13, Ped/Neonatal ICU 8, Adult floor
    48, Peds floor 9)

120
UNC HOSPITAL PREPAREDNESSUNDECIDED ISSUES
  • Management of patients if beds unavailable and
    transfer impossible
  • Use of unlicensed beds? (e.g., PACU, 24 hours
    holding unit, clinics)?
  • Use of temporary facilities
  • Triage/management of patients if ventilators
    unavailable
  • Who lives and who dies
  • Stockpiling of oseltamavir
  • Pros Reduce anxiety among HCWs, availability
    even if national shortage
  • Cons Expense, out dating of drug, reduce
    availability to public
  • Currently unavailable
  • Use for prophylaxis at discretion of Medical
    Director, OHS

121
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