20092010 Seasonal and Pandemic Influenza Vaccine Update

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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

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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

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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)

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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

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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

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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

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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

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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
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Vaccine ancillary supplies provided with the
vaccine

• Needle/syringe units for multidose vials
• Sharps containers
• Alcohol pads
• Mixing syringes if adjuvanted vaccine is used

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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

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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

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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)

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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
  personnel
• (because illness is distinctly uncommon in
  elderly, they will not be a priority)

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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
  signals.
• Active surveillance for Guillain Barre Syndrome
  through states in Emerging Infections Program
  (including TN).

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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

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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)

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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

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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)

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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

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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

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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

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Discussion

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

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Update on Infection Control

• Marion Kainer MD MPH
• Director, Hospital Infections Program,
• Tennessee Department of Health

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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

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• 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)

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Think H1N1 Just because it is not in the media,
it has NOT disappeared
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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

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Current TDH Guideline

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

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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)

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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)

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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

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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

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Aerosol-Generating Procedures (HICPAC 7/23/2009)

• Intubation
• Bronchoscopy
• Induced Sputum
• Open Suctioning
• CPR