2009-2010 Seasonal and Pandemic Influenza Vaccine Update
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2009-2010 Seasonal and Pandemic Influenza Vaccine Update






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2009-2010 Seasonal and Pandemic Influenza Vaccine Update 2009-2010 Seasonal and Pandemic Influenza Vaccine Update Presentation Transcript

  • 2009-2010 Seasonal and Pandemic Influenza Vaccine Update Kelly L. Moore, MD, MPH Medical Director, Immunization Program TN Department of Health Tennessee Hospital Association Webinar July 27, 2009
  • Objectives
    • 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 blockers)
    • 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 administration
  • 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 vaccine
    • 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 >6 m) and staff (all ages) in child care centers
    • Pregnant women, children 6m-4yrs, new parents and household contacts of children <6 m
    • Non-elderly adults (age <65) with medical conditions that increase risk of complications
    • Health care workers and emergency services personnel
    • (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.htm ) for signal detection
    • Network of MCOs representing ~3% of U.S. pop., the Vaccine Safety Datalink (VSD) to test signals.
    • 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 members
  • 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 Information/Shipment
    • 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 Information/Shipment
    • 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 (email/fax)
      • 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 valuable
  • 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 locations?
    • Much has yet to be decided - make plans practical and flexible
  • Discussion
    • Thank you!
    • Kelly Moore, MD, MPH
    • [email_address]
    • 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 H1N1)
    • 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 ordered)
  • 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/infection_control/en/index.html .
    • For a ll 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 staff)
    • 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 procedures
      • 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 procedures
    • 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