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2009-2010 Seasonal and Pandemic Influenza Vaccine Update
Kelly L. Moore, MD, MPHMedical Director, Immunization Program
TN Department of HealthTennessee 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
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/public
ations/infection_control/en/index.html.
• 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 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