Novel influenza A H1N1

1
Novel influenza A (H1N1)

• Rebecca Sunenshine, MD
• Peter Kelly, MD
• Karen Lewis, MD
• Arizona Department of Health Services
• September 11, 2009

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Overview of Novel H1N1 influenza

• Epidemiology of novel H1N1 in Arizona
• Infection control
• Clinical management
• Diagnosis
• Novel H1N1 influenza Vaccine
• ADHS website

3
In the beginning

• April 15, 2009
• 2 cases of swine influenza A (H1N1)
• Residents of adjacent counties in Southern
  California
• Viruses are genetically related to each other
• Contain a unique genetic sequence not previously
  identified in human and swine influenza viruses
• No exposure to swine
• Novel influenza A virus different from currently
  seasonal influenza subtypes A H1N1 and A H3N2

4
Novel H1N1 Epidemiology

• Same as seasonal flu
• Incubation period 1-4 days
• Infectious 1 day before symptoms develop and up
  to 7 days after becoming sick
• Transmission
• Person-person via droplets from coughing or
  sneezing of infected persons
• Fomites and Direct Contact limited
• Some animal data showing increased replication in
  the lungs

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Descriptive Statistics of Novel A (H1N1) Cases
Reported to ADHS, September 9, 2009

• 1347 cases reported to ADHS
• Identified cases in 14/15 Counties
• Age Range 9 days 86 years
• Median Age 15 Years (mean 21 yrs)
• 654 (49) Female
• Hospitalizations 257 (19)
• Deaths 21 (1.6)

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Confirmed Novel H1N1 by Age GroupAs of September
9, 2009 (N1,347)
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Reported Novel H1N1 Cases by Race/ethnicityAs of
August 26, 2009 (N1,157)
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Descriptive Statistics of Novel A (H1N1)
Hospitalized Cases Reported to ADHSSeptember 9,
2009 (N257)

• 257 Hospitalized cases
• Age range 9 days 86 years
• Median age 22 years (mean 27 years)
• 131 (51) Female

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Reported Novel H1N1 Hospitalizations by Age Group
As of August 26, 2009 (N191)
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Reported Novel H1N1 Hospitalizations by
Race/EthnicityAs of August 26, 2009 (N191)
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Conditions Among Reported H1N1 Hospitalized Cases
and Deaths
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Novel A (H1N1) Associated Deaths Reported to
ADHS, August 19, 2009

• 21 Reported deaths
• Age range 1 year 77 years
• Median age 49 years
• Mean age 39 years
• 12 (57) Female
• 100 have underlying medical conditions

13
Reported Novel H1N1-related Deaths by Age Group,
As of September 9, 2009 (N21)
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AHDS Infection Control Guidance in Healthcare
Settings

• For all patients with a febrile respiratory
  illness (i.e., not just suspect or confirmed
  cases of H1N1)
• Hand hygiene (patient and staff)
• Respiratory hygiene (patient and staff)
• Standard precautions (i.e., treat all body fluids
  as potentially infectious, including stool wear
  gown, gloves and eye-protection if risk of
  splash) NOTE Data based on ferret models from
  CDC indicates that this virus is shed in the
  stool

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AHDS Infection Control Guidance in Healthcare
Settings

• Wear surgical mask within 6 feet of a patient
  with a febrile respiratory illness
• Wear an N-95 respirator (fit-tested) or PAPR
  eye-protection (face-shield or goggles) gown and
  gloves (all persons in the room) IF conducting
  aerosol-generating medical procedures

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Aerosol-generating Procedures

• Endotracheal intubation
• Suctioning (if not using a closed system)
• Bronchoscopy
• Resuscitation involving emergency intubation or
  cardiac pulmonary resuscitation

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Duration of Precautions

• Isolation precautions should be continued for
  seven (7) days from symptom onset or until the
  resolution of symptoms, whichever is longer
• Prolonged mechanical ventilation can remove
  after 10 days from illness onset with negative
  PCR (endotracheal aspirate)
• Excludes immunosuppressed patients

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Healthcare Workers with ILI

• Healthcare personnel who develop a febrile
  respiratory illness should be excluded from work
  for 7 days or until symptoms have resolved,
  whichever is longer.

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Healthcare Settings

• Acute care hospitals
• Long term care facilities
• Assisted living facilities
• Outpatient facilities
• Hemodialysis centers
• Adult daycare facilities

20
Contamination and Cleaning

• Influenza virus can survive on environmental
  surfaces up to 2 to 8 hours.
• Can be destroyed by heat
• Chemical germicides, including chlorine, hydrogen
  peroxide, soap, and alcohol, are effective
  against human influenza viruses
• Your typical household disinfectants are
  effective
• Use according to directions on product label

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Pandemic H1N1Management and Treatment

• Peter C. Kelly, M.D.
• Public Health Emergency Preparedness

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Signs and Symptoms(NEJM 20093602605-15.)

• 642 confirmed cases
• Age median 20yrs, range 3mo.-81 yrs
• On presentation
• Fever 94
• Cough 92
• Sore throat 66
• Diarrhea and vomiting 25 each

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Diagnostic Tests in the Epidemic

• Patient with compatible illness or ILI
• Rapid tests on respiratory secretions
• If you have a working dx
• If negative does not exclude
• Viral culture of NP secretions diagnostic if
  but lower yield than PCR
• PCR quickest and most sensitive. Preferred test

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Bottom Line on Diagnostic Tests

• Positive tests count
• Negative tests dont count
• Clinical judgment matters
• Do not wait for test results to decide on
  treatment

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Hospitalization Data(NEJM 20093602605-15)

• 9 of 399 cases hospitalized (36)
• CXR infiltrates 50
• ICU admission 36, mechan. vent 18
• Oseltamivir treatment 74
• Full recovery 82
• Died 6

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Adult Severe Illness(MMWR 200958, 749-52)

• 10 cases of ARDS, median age 46yrs
• 9 men
• 9/10 morbid obesity
• 9/10 septic shock
• 6/10 pulmonary emboli (hypercoagulable state)
• 7 survived with advanced ICU care
• Median time to antivirals meds 8 days

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Children Severe Illness(MMWR 2009, 58773-77)

• 4 cases, age 7-17, all males
• Presented with ILI and seizures or altered mental
  status
• EEG abnormal in 3/3
• CSF benign and negative H1N1 on PCR
• Scans ¾ normal
• All treated with oseltamivir
• All survived without sequelae

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Pediatric Deaths(COCA Conf. Call 9/8/09)

• 36 cases , lt18 yrs, 15 states
• 67 at least 1 high risk condition
• gt90 neurodevelopmental abnormalities eg cerebral
  palsy
• 41 pulmonary problem
• 50 had bacterial co-infection

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Heads up!Vulnerable Hosts

• High risk hosts cardio-pulmonary, asthma,
  pregnant, immune suppressed, neuromuscular
  disorders, diabetes, elderly
• Morbid obesity BMI 30 - 40
• Children with neurodevelopmental abnormalities eg
  cerebral palsy
• Native Americans

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Treatment for Pandemic H1N1 Influenza

• As of Sept. 11, 2009

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Key Concept

• Oseltamivir or Zanamivir
• Sooner the better
• Do not wait for lab diagnosis

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Updated Interim Recommendations etc

• Clinical judgment matters (Colin Powells rule)
• Do not delay treatment pending a diagnosis
• Treat all ill enough to be hospitalized
• Treat high risk hosts with suspected influenza
• Kidslt5, gt65 ,pregnant,chronic diseases, lt19yrs on
  ASA

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How about normal hosts with ILI?

• Treatment usually not required
• Unless
• Dyspnea, tachypnea
• Oxygen desaturation
• Are they ill enough to be hospitalized?

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• Pregnancy is not a contraindication to
  oseltamivir or zanamivir

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Oseltamivir Dosage

• Adults 75mg capsule BID. Five days
• Children gt 12 mo
• 15kg or less 60mg daily in 2 divided doses
• 16-23 kg 90mg daily in 2 divided doses
• 24-40 kg 120 mg daily in 2 divided doses
• gt40 kg 150 daily in 2 divided doses
• Five day duration

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Zanamivir Dosing

• Adults Two 5mg inhalation twice a day. Five days
• Children age 7yrs or older Two 5 mg inhalations
  twice a day. Five days

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Other Dose Considerations

• Based on clinical judgment
• Can increase daily dose (double)
• Can extend the duration of treatment
• Reserve for very ill patients

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Vulnerable Hosts (aka high risk)

• Pre illness prescriptions for oseltamivir or
  zanamivir
• Consider initiating treatment based telephone
  contact

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Novel H1N1 Influenza Vaccine in ArizonaKaren
Lewis, M.D.September 11, 2009

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Five ACIP Target Groups for Prioritization

• Pregnant women
• 6 mo-24 years
• Caretakers lt 6 mo
• HCWs
• Chronic conditions 25-64 yo

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Target Groups for Prioritization

• Adequate supplies
• Pregnant women
• 6 mo-24 years
• Caretakers lt 6 mo
• HCWs
• Chronic conditions 25-64 yo

• Limited supplies
• Pregnant women
• 6 mo-4 yo
• Caretakers lt 6 mo
• HCWs with direct patient care
• Chronic conditions 5 -18 yo

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Expand H1N1 Vaccine Groups with Availability
TARGET GROUPS 159 Million
HEALTHY ADULTS 25-64 yo 103 Million
ADULTS gt 65 yo 38 Million
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Novel H1N1 Influenza VaccineClinical Trials

• 15 mcg versus 30 mcg
• With and without adjuvant
• One dose or two
• Together with seasonal vaccine or separate
• Combinations of TIV/LAIV

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Novel H1N1 Influenza Vaccine

• Licensed through FDA
• 15 mcg of antigen No adjuvant
• Two doses gt 21 days apart
• Five manufacturer
• Specific age restrictions
• Inactivated Live attenuated
• Multidose vials, prefilled syringes, nasal spray

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H1N1 Monovalent Vaccine

• Federally funded
• Vaccine
• Ancillary supplies
• Needles, syringes, alcohol wipes, sharps
  containers, vaccine record cards
• Central distributor
• ADHS takes order from provider
• Distributor ships directly to provider

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Five Vaccine Manufacturers
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Five Vaccine Manufacturers
Contains thimerosal
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Ordering H1N1 Vaccine through ADHS

• ADHS sends packet to providers
• Order Form
• Provider Agreement
• Storage Handling Information
• Reporting Instructions

Preregister at www.azdhs.gov or fax (602)
364-3232

• Provider
• Fills out order form
• Signs provider agreement
• Makes sure practice has adequate type of
  refrigerator

County health officers give prioritization
guidance

• ADHS
• Reviews orders signed agreement
• Prioritizes orders
• Distributor informs ADHS of allotment
• Sends prioritized orders to distributor

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Ordering H1N1 Vaccine through ADHS
Distributor --Gets order
from ADHS --Sends vaccine directly to provider
--Min order of 100 doses

• ADHS
• Reviews orders signed agreement
• Told of vaccine availability by distributor
• Prioritizes orders based on county guidance
• Sends orders to distributor

• Provider receives vaccine
• If only partial order received, OR,
• If full order received, but provider needs more
  vaccine
• ?Provider sends new vaccine order to ADHS

• ADHS options
• Submits providers full order (100 dose
  increments) or
• Submits a partial order (100
  dose increments), or
• Order not immediately submitted.

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ADHS H1N1 VaccineOrdering Packet

• Provider agreement
• Order form
• Weekly reporting forms
• Storage and handling
• Vaccine Safety Information

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Provider Agreement

• Cannot charge for vaccine
• Can charge administration fee
• Public providers cannot turn patients away
• Record keeping
• Weekly report to ADHS by age groups
• Follow priority groups
• Properly handle vaccine
• 2-8º F.

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How Vaccine Comes

• Minimum order of 100 doses per presentation
• Multidose vial (10 doses)
• Pre-filled single dose syringes
• Nasal spray
• Reorder from ADHS as needed if
• Order only partially filled
• Additional demand

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Current Timelines for Shipping

• Projected initial 40 million dose bolus
• (AZ 900,000 doses)
• Weekly 10-20 million doses to follow
• (AZ 200,000-400,000)
• Mid-October start?
• At first, more multidose and nasal spray

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Approach to H1N1 and Seasonal Influenza Vaccines

• Give seasonal vaccine ASAP
• Can give H1N1 and seasonal vaccines together
• Both injectable
• One injectable, one LAIV
• Cannot give both LAIV at the same time
• Can use different manufacturers for the two doses

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Strategies to vaccinate pregnant women

• Educate women
• Trivalent Vaccine safe in all trimesters
• Antibodies spread transplacentally
• Prescription from physician?
• ADHS form
• www.azdhs.gov

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OVERLAPPING EVENTS
H1N1 INFLUENZA

• ___________________________________
• Sept Oct Nov Dec Jan Feb Mar April

SEASONAL FLU VACCINE
H1N1 VACCINE
SEASONAL INFLUENZA
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"Roll Up Your Sleeves, America"

• Swine Influenza 1976
• Fort Dix, New Jersey
• 1 death
• 4 pneumonia
• gt200 infected
• 40 million vaccinated

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Guillain-Barré Syndrome 1976 Swine Flu Vaccine

• Annual incidence GBS
• 1-2 cases/100,000 adults
• 1976 1 additional case GBS/100,000
• Subsequent yearsNo risk or minimal
• Subsequent influenza vaccines
• Risk 1 per million doses
• Influenza can trigger GBS
• Four to seven times higher risk than vaccine

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Monitoring for Rare Adverse Events

• Vaccine Adverse Events Reporting System (VAERS)
• Report significant clinical adverse events
• www.vaers.hhs.gov
• Vaccine Safety Datalink
• Active surveillance for Guillain-Barré Syndrome

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Legal Protection to Physicians

• PREP Act
• Public Readiness and Emergency Preparedness Act
• Immunity from tort liability for individuals and
  entities administering novel H1N1 influenza
  vaccine
• Except for willful misconduct

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Influenza Vaccine Resources

• Ordering novel H1N1 influenza vaccine
• www.azdhs.gov
• Use of Influenza A (H1N1) 2009 Monovalent
  Vaccine. MMWR August 28, 2009 http//www.cdc.gov/
  mmwr/PDF/rr/rr5810.pdf
• Prevention and Control of Seasonal Influenza with
  Vaccines. MMWR July 31, 2009.
  http//www.cdc.gov/mmwr/PDF/rr/rr5808.pdf

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Additional Information

• For latest information on novel H1N1 visit the
  ADHS website at
• www.azdhs.gov/flu/h1n1
• Or visit the CDC website at
• www.cdc.gov/h1n1flu/

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