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20092010 Seasonal and Pandemic Influenza Vaccine Update


Unadjuvanted pandemic H1N1 vaccine may be licensed in a manner similar to a ... N-95 respirators for all direct patient contact if suspected/confirmed H1N1 ... – PowerPoint PPT presentation

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Title: 20092010 Seasonal and Pandemic Influenza Vaccine Update

2009-2010 Seasonal and Pandemic Influenza Vaccine
  • Kelly L. Moore, MD, MPH
  • Medical Director, Immunization Program
  • TN Department of Health
  • Tennessee Hospital Association Webinar
  • July 27, 2009

  • Seasonal vaccine
  • One dose, LAIV (nasal spray) or TIV (injection)
  • Will arrive in clinics first
  • 115 million doses for the season
  • Pandemic vaccine
  • Expected 2 doses, at least 3 weeks apart
  • LAIV or TIV
  • Could start shipping by mid-late October
  • Up to 600 million doses, if demand exists

2009-2010 Seasonal Influenza Vaccine
  • an A/Brisbane/59/2007 (H1N1)-like virus
  • an A/Brisbane/10/2007 (H3N2)-like virus
  • a B/Brisbane/60/2008-like virus (new)
  • Production on schedule
  • Majority of doses distributed by the end of
    October (though distribution likely to continue
    into December)

Seasonal Influenza Vaccination Advice
  • Critical importance of seasonal vaccine is
    undiminished by pandemic virus
  • Seasonal strains more likely to kill elderly
  • Seasonal strain drug resistance
  • Seasonal H1N1 resistant to oseltamivir
  • Seasonal H3N2 resistant to adamantanes (M2
  • Seasonal viruses continue to circulate in
    Southern Hemisphere season
  • Opportunities for genetic recombination

Seasonal Influenza Vaccination Advice
  • Vaccinate as soon as supplies permit
  • Protection will not wane through season
  • Get inventory out of the way before pandemic
    vaccine arrives
  • Easier to attribute cause of adverse events if
    not co-administered with pandemic vaccine
  • Use opportunity to educate about pandemic
    influenza and forthcoming vaccine
  • Treat both pandemic and seasonal vaccine as
    important and essential for safe patient care

Pandemic H1N1 Virus
  • Circulating through the summer
  • Expected to increase when school resumes
  • An early fall wave 2 is likely
  • Vaccine distribution expected by mid-late October
    (after disease prevalent)
  • Clinical trials beginning

Pandemic Vaccine Manufacturers
  • Novartis (45.7)
  • - Also manufactures MF59 adjuvant for potential
    pre-formulation with vaccine
  • Sanofi Pasteur (26.4)
  • CSL (18.7)
  • MedImmune (5.8)
  • GSK (3.4)
  • - Also manufactures ASO3 adjuvant in a separate
    vial for potential mixing at the place of

Vaccine products (general)
  • Unadjuvanted multidose vials
  • Unadjuvanted p-free pre-loaded syringes
  • Nasal sprayers (live attenuated)
  • Potentially
  • Multidose vials pre-formulated with adjuvant
  • Multidose vials formulated for adjuvant to be
    mixed at the place of administration (separate
    antigen and adjuvant vials)

All multidose vials will contain thimerosal
preservative Up to 20 of vaccine may be p-free
pediatric formulation
Vaccine ancillary supplies provided with the
  • Needle/syringe units for multidose vials
  • Sharps containers
  • Alcohol pads
  • Mixing syringes if adjuvanted vaccine is used

Emergency Use Authorization Maybe, Maybe Not
  • … use of an unapproved medical product or an
    unapproved use of an approved medical product
    during a declared emergency …
  • - Unadjuvanted pandemic H1N1 vaccine may be
    licensed in a manner similar to a seasonal flu
    vaccine strain change and therefore would not
    need an EUA
  • - Adjuvanted vaccines, if used (for the 2009-10
    flu season), will be administered under an EUA

Vaccine purchase, allocation, and distribution
  • Vaccine procured and purchased by US government
  • Vaccine will be allocated across states
    proportional to population
  • Vaccine will be sent to state-designated
    receiving sites mix of local health departments
    and private settings

Vaccine planning assumptions
  • Vaccine available starting mid-October
  • Initial amount 40, 80, or 160 million doses
  • distributed in the first month
  • Subsequent weekly production 10, 20 or 30
    million doses distributed
  • 2 doses required (21 or 28 days apart)

Vaccine planning assumptions probable target
groups if early supplies are limited
  • Students and staff (all ages) associated with
    schools (K-12) and children (age gt6 m) and staff
    (all ages) in child care centers
  • Pregnant women, children 6m-4yrs, new parents and
    household contacts of children lt6 m
  • Non-elderly adults (age lt65) with medical
    conditions that increase risk of complications
  • Health care workers and emergency services
  • (because illness is distinctly uncommon in
    elderly, they will not be a priority)

Monitoring vaccine safety
  • Vaccine Adverse Event Reporting System (VAERS)
    (1-800-822-7967, http//vaers.hhs.gov/contact.ht
    m ) for signal detection
  • Network of MCOs representing 3 of U.S. pop.,
    the Vaccine Safety Datalink (VSD) to test
  • Active surveillance for Guillain Barre Syndrome
    through states in Emerging Infections Program
    (including TN).

Monitoring vaccine effectiveness (VE)
  • VE for prevention of PCR-confirmed medically
    attended influenza at 4 community-based sites
  • VE for prevention of influenza hospitalizations
    diagnosed by provider-ordered clinically
    available tests at 10 sites nationwide through
    the Emerging Infections Program (includes TN)
  • DoD will be assessing VE in active duty service

Vaccine Delivery Model
  • Public health-coordinated effort
  • Blends vaccination in public health-organized
    clinics and in the private sector (provider
    offices, workplaces, retail settings)
  • Tennessee will pre-register all non-public health
    facilities needing vaccine directly shipped
    (including all hospitals)

Tennessee Pre-Registration for Pandemic Vaccine
  • No cost, no obligation to order vaccine
  • Only for facilities considering providing vaccine
  • Includes hospitals, medical clinics, immunizing
    pharmacists, contract mass vaccinators
  • Expected to go live about August 5
  • Updates emailed to registrants, including
    ordering instructions

Tennessee Pre-Registration for Pandemic Vaccine
  • 2-step registration
  • Register to use the Tennessee Web Immunization
    System (TWIS), Registry
  • Takes about 2 days to receive user id and
    password for TWIS
  • After log-on with user id / password, prompted to
    register for pandemic vaccine information
  • All registered providers will have full access to
    TWIS resources, including self-guided tutorial
    (renewal would be necessary in 1 year)

TN Pre-Registration for Pandemic Vaccine, contd.
  • Registration serves multiple purposes
  • Obtain contact information
  • Authorized Immunization Provider
  • Primary Point of Contact (will receive MOA and
    ordering instructions
  • Shipping Contact (to receive shipments)
  • Establish shipping record
  • Enable direct communication of new info
  • Gauge interest in the private sector
  • Estimate number of healthcare staff, others the
    facility plans to vaccinate

Provider Registration
  • Hospitals will need to register
  • Programming underway
  • Notice will come through THA once system is live
    (within 2 weeks)
  • Hospitals are priority vaccine recipients, will
    have to submit orders, follow reporting reqts.
  • Weekly Survey Monkey questionnaire on total doses
    administered by age category, dose 1 or 2
  • Not required to record doses in TWIS, but may be

Pandemic Vaccine Planning
  • Cannot predict when vaccine will arrive, size of
    initial shipments
  • Begin planning strategies
  • Seasonal vaccine (Sept-Oct)
  • Pandemic 1 (Oct-Nov)
  • Pandemic 2 (3-4 weeks after 1)
  • Storage space? Communications? Time and
  • Much has yet to be decided - make plans practical
    and flexible

  • Thank you!
  • Kelly Moore, MD, MPH
  • Kelly.moore_at_tn.gov
  • 615-741-7247

Update on Infection Control
  • Marion Kainer MD MPH
  • Director, Hospital Infections Program,
  • Tennessee Department of Health

Recent Infection Control Breaches in TN
  • Multiple instances of NO precautions (no PPE at
    all) taken by HCWs in looking after patients with
    fever and respiratory distress (later confirmed
  • Intubation, bronchoscopy, open suctioning
  • Hundreds of HCWs exposed PEP
  • Some HCW infected, some severely ill
  • Infected HCWs went to work exposed co-workers
    and patients

  • H1N1 was considered in the differential diagnosis
    (specimen taken), but NOT communicated to IP or
    other staff
  • Patient NOT placed in isolation
  • Patient did NOT receive antivirals
  • One patient died
  • Improve communications (consider closing loop
    with laboratory notifying IP if H1N1 test is

Think H1N1 Just because it is not in the media,
it has NOT disappeared
Current Published CDC Guidelines
  • Respiratory etiquette
  • Hand Hygiene
  • N-95 respirators for all direct patient contact
    if suspected/confirmed H1N1
  • Prefer negative pressure room if performing
    aerosol-generating procedure

Current TDH Guideline
  • Similar to WHO and Health Canada
  • http//www.who.int/csr/resources/publications/infe
  • For all patients with a febrile respiratory
    illness (FRI) (i.e., not just suspect or
    confirmed cases of H1N1)

Current TDH Guideline- All FRI
  • Practice good hand hygiene (patient and staff)
  • Practice good respiratory hygiene (patient and
  • Practice standard precautions (i.e., treat all
    body-fluids as potentially infectious, including
    stool wear gown, gloves and eye-protection if
    risk of splash)

Current TDH Guideline All FRI
  • Wear surgical mask if within 6 feet if
  • the patient is compliant (willing and able) with
    respiratory hygiene practices or
  • the patient has a weak or no cough
  • individuals who may have a weak cough are the
    frail elderly and pediatric patients.
  • Wear a N-95 respirator (fit-tested)
  • Eye-protection (face-shield or goggles)
  • Gown and gloves
  • IF conducting aerosol-generating medical
  • OR
  • WHEN the patient is coughing forcefully AND the
    patient is unable/unwilling to comply with
    respiratory hygiene (e.g., coughing patient who
    is unable or unwilling to wear a surgical mask)

Current TDH Guideline
  • Face-shields are preferred over goggles because
  • goggles may alter facial contours and impair the
    proper fit of N-95 respirators that were
    fit-tested without wearing goggles
  • face-shields are easier to clean than goggles
  • Face-shields should cover the eyes and preferably
    extend over the chin

CDC Guidelines May Change
  • APIC/SHEA position statement
  • HICPAC voted for following recommendation to CDC
  • Standard precautions
  • Droplet precautions
  • N-95 Eye protection for aerosol-generating
  • Waiting for IOM report
  • (8/11 meeting report by 8/30)
  • September 1 possible guideline change

Aerosol-Generating Procedures (HICPAC 7/23/2009)
  • Intubation
  • Bronchoscopy
  • Induced Sputum
  • Open Suctioning
  • CPR
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