2009-2010 Seasonal and Pandemic Influenza Vaccine Update


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2009-2010 Seasonal and Pandemic Influenza Vaccine Update

  1. 1. 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
  2. 2. Objectives <ul><li>Seasonal vaccine </li></ul><ul><ul><li>One dose, LAIV (nasal spray) or TIV (injection) </li></ul></ul><ul><ul><li>Will arrive in clinics first </li></ul></ul><ul><ul><li>~115 million doses for the season </li></ul></ul><ul><li>Pandemic vaccine </li></ul><ul><ul><li>Expected 2 doses, at least 3 weeks apart </li></ul></ul><ul><ul><li>LAIV or TIV </li></ul></ul><ul><ul><li>Could start shipping by mid-late October </li></ul></ul><ul><ul><li>Up to 600 million doses, if demand exists </li></ul></ul>
  3. 3. 2009-2010 Seasonal Influenza Vaccine <ul><li>an A/Brisbane/59/2007 (H1N1)-like virus </li></ul><ul><li>an A/Brisbane/10/2007 (H3N2)-like virus </li></ul><ul><li>a B/Brisbane/60/2008-like virus (new) </li></ul><ul><li>Production on schedule: </li></ul><ul><li>Majority of doses distributed by the end of October (though distribution likely to continue into December) </li></ul>
  4. 4. Seasonal Influenza Vaccination Advice <ul><li>Critical importance of seasonal vaccine is undiminished by pandemic virus </li></ul><ul><li>Seasonal strains more likely to kill elderly </li></ul><ul><li>Seasonal strain drug resistance </li></ul><ul><ul><li>Seasonal H1N1 resistant to oseltamivir </li></ul></ul><ul><ul><li>Seasonal H3N2 resistant to adamantanes (M2 blockers) </li></ul></ul><ul><li>Seasonal viruses continue to circulate in Southern Hemisphere season </li></ul><ul><li>Opportunities for genetic recombination </li></ul>
  5. 5. Seasonal Influenza Vaccination Advice <ul><li>Vaccinate as soon as supplies permit </li></ul><ul><ul><li>Protection will not wane through season </li></ul></ul><ul><ul><li>Get inventory out of the way before pandemic vaccine arrives </li></ul></ul><ul><ul><li>Easier to attribute cause of adverse events if not co-administered with pandemic vaccine </li></ul></ul><ul><ul><li>Use opportunity to educate about pandemic influenza and forthcoming vaccine </li></ul></ul><ul><ul><li>Treat both pandemic and seasonal vaccine as important and essential for safe patient care </li></ul></ul>
  6. 6. Pandemic H1N1 Virus <ul><li>Circulating through the summer </li></ul><ul><li>Expected to increase when school resumes </li></ul><ul><li>An early fall wave 2 is likely </li></ul><ul><li>Vaccine distribution expected by mid-late October (after disease prevalent) </li></ul><ul><li>Clinical trials beginning </li></ul>
  7. 7. Pandemic Vaccine Manufacturers <ul><li>Novartis (45.7%) </li></ul><ul><ul><li>- Also manufactures MF59 adjuvant for potential pre-formulation with vaccine </li></ul></ul><ul><li>Sanofi Pasteur (26.4%) </li></ul><ul><li>CSL (18.7%) </li></ul><ul><li>MedImmune (5.8%) </li></ul><ul><li>GSK (3.4%) </li></ul><ul><ul><li>- Also manufactures ASO3 adjuvant in a separate vial for potential mixing at the place of administration </li></ul></ul>
  8. 8. Vaccine products (general) <ul><li>Unadjuvanted multidose vials * </li></ul><ul><li>Unadjuvanted p-free pre-loaded syringes † </li></ul><ul><li>Nasal sprayers (live attenuated) † </li></ul><ul><li>Potentially </li></ul><ul><li>Multidose vials pre-formulated with adjuvant </li></ul><ul><li>Multidose vials formulated for adjuvant to be mixed at the place of administration (separate antigen and adjuvant vials) </li></ul>* All multidose vials will contain thimerosal preservative † Up to 20% of vaccine may be p-free pediatric formulation
  9. 9. Vaccine ancillary supplies: provided with the vaccine <ul><li>Needle/syringe units for multidose vials </li></ul><ul><li>Sharps containers </li></ul><ul><li>Alcohol pads </li></ul><ul><li>Mixing syringes if adjuvanted vaccine is used </li></ul>
  10. 10. Emergency Use Authorization: Maybe, Maybe Not <ul><li>“… use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency …” </li></ul><ul><ul><li>- 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 </li></ul></ul><ul><ul><li>- Adjuvanted vaccines, if used (for the 2009-10 flu season), will be administered under an EUA </li></ul></ul>
  11. 11. Vaccine purchase, allocation, and distribution <ul><li>Vaccine procured and purchased by US government </li></ul><ul><li>Vaccine will be allocated across states proportional to population </li></ul><ul><li>Vaccine will be sent to state-designated receiving sites: mix of local health departments and private settings </li></ul>
  12. 12. Vaccine planning assumptions : <ul><li>Vaccine available starting mid-October </li></ul><ul><li>Initial amount: 40, 80, or 160 million doses </li></ul><ul><li>distributed in the first month </li></ul><ul><li>Subsequent weekly production: 10, 20 or 30 million doses distributed </li></ul><ul><li>2 doses required (21 or 28 days apart) </li></ul>
  13. 13. Vaccine planning assumptions: probable target groups if early supplies are limited <ul><li>Students and staff (all ages) associated with schools (K-12) and children (age >6 m) and staff (all ages) in child care centers </li></ul><ul><li>Pregnant women, children 6m-4yrs, new parents and household contacts of children <6 m </li></ul><ul><li>Non-elderly adults (age <65) with medical conditions that increase risk of complications </li></ul><ul><li>Health care workers and emergency services personnel </li></ul><ul><li>(because illness is distinctly uncommon in elderly, they will not be a priority) </li></ul>
  14. 14. Monitoring vaccine safety <ul><li>Vaccine Adverse Event Reporting System (VAERS) (1-800-822-7967, http:// vaers.hhs.gov/contact.htm ) for signal detection </li></ul><ul><li>Network of MCOs representing ~3% of U.S. pop., the Vaccine Safety Datalink (VSD) to test signals. </li></ul><ul><li>Active surveillance for Guillain Barre Syndrome through states in Emerging Infections Program (including TN). </li></ul>
  15. 15. Monitoring vaccine effectiveness ( VE ) <ul><li>VE for prevention of PCR-confirmed medically attended influenza at 4 community-based sites </li></ul><ul><li>VE for prevention of influenza hospitalizations diagnosed by provider-ordered clinically available tests at 10 sites nationwide through the Emerging Infections Program (includes TN) </li></ul><ul><li>DoD will be assessing VE in active duty service members </li></ul>
  16. 16. Vaccine Delivery Model <ul><li>Public health-coordinated effort </li></ul><ul><li>Blends vaccination in public health-organized clinics and in the private sector (provider offices, workplaces, retail settings) </li></ul><ul><li>Tennessee will pre-register all non-public health facilities needing vaccine directly shipped (including all hospitals) </li></ul>
  17. 17. Tennessee Pre-Registration for Pandemic Vaccine Information/Shipment <ul><li>No cost, no obligation to order vaccine </li></ul><ul><li>Only for facilities considering providing vaccine </li></ul><ul><li>Includes hospitals, medical clinics, immunizing pharmacists, contract mass vaccinators </li></ul><ul><li>Expected to go live about August 5 </li></ul><ul><li>Updates emailed to registrants, including ordering instructions </li></ul>
  18. 18. Tennessee Pre-Registration for Pandemic Vaccine Information/Shipment <ul><li>2-step registration </li></ul><ul><ul><li>Register to use the Tennessee Web Immunization System (TWIS), “Registry” </li></ul></ul><ul><ul><li>Takes about 2 days to receive user id and password for TWIS </li></ul></ul><ul><ul><li>After log-on with user id / password, prompted to register for pandemic vaccine information </li></ul></ul><ul><ul><li>All registered providers will have full access to TWIS resources, including self-guided tutorial (renewal would be necessary in 1 year) </li></ul></ul>
  19. 19. TN Pre-Registration for Pandemic Vaccine, contd. <ul><li>Registration serves multiple purposes: </li></ul><ul><ul><li>Obtain contact information </li></ul></ul><ul><ul><ul><li>Authorized Immunization Provider </li></ul></ul></ul><ul><ul><ul><li>Primary Point of Contact (will receive MOA and ordering instructions </li></ul></ul></ul><ul><ul><ul><li>Shipping Contact (to receive shipments) </li></ul></ul></ul><ul><ul><li>Establish shipping record </li></ul></ul><ul><ul><li>Enable direct communication of new info (email/fax) </li></ul></ul><ul><ul><li>Gauge interest in the private sector </li></ul></ul><ul><ul><ul><li>Estimate number of healthcare staff, others the facility plans to vaccinate </li></ul></ul></ul>
  20. 20. Provider Registration <ul><li>Hospitals will need to register </li></ul><ul><li>Programming underway </li></ul><ul><li>Notice will come through THA once system is live (within 2 weeks) </li></ul><ul><li>Hospitals are priority vaccine recipients, will have to submit orders, follow reporting reqts. </li></ul><ul><ul><li>Weekly Survey Monkey questionnaire on total doses administered by age category, dose #1 or #2 </li></ul></ul><ul><ul><li>Not required to record doses in TWIS, but may be valuable </li></ul></ul>
  21. 21. Pandemic Vaccine Planning <ul><li>Cannot predict when vaccine will arrive, size of initial shipments </li></ul><ul><li>Begin planning strategies </li></ul><ul><ul><li>Seasonal vaccine (Sept-Oct) </li></ul></ul><ul><ul><li>Pandemic #1 (Oct-Nov) </li></ul></ul><ul><ul><li>Pandemic #2 (3-4 weeks after #1) </li></ul></ul><ul><ul><li>Storage space ? Communications? Time and locations? </li></ul></ul><ul><li>Much has yet to be decided - make plans practical and flexible </li></ul>
  22. 22. Discussion <ul><li>Thank you! </li></ul><ul><li>Kelly Moore, MD, MPH </li></ul><ul><li>[email_address] </li></ul><ul><li>615-741-7247 </li></ul>
  23. 23. Update on Infection Control Marion Kainer MD MPH Director, Hospital Infections Program, Tennessee Department of Health
  24. 24. Recent Infection Control Breaches in TN <ul><li>Multiple instances of NO precautions (no PPE at all) taken by HCWs in looking after patients with fever and respiratory distress (later confirmed H1N1) </li></ul><ul><li>Intubation, bronchoscopy, open suctioning </li></ul><ul><li>Hundreds of HCWs exposed: PEP </li></ul><ul><ul><li>Some HCW infected, some severely ill </li></ul></ul><ul><ul><li>Infected HCWs went to work & exposed co-workers and patients </li></ul></ul>
  25. 25. <ul><li>H1N1 was considered in the differential diagnosis (specimen taken), but NOT communicated to IP or other staff </li></ul><ul><li>Patient NOT placed in isolation </li></ul><ul><li>Patient did NOT receive antivirals </li></ul><ul><li>One patient died </li></ul><ul><li>Improve communications (consider closing loop with laboratory notifying IP if H1N1 test is ordered) </li></ul>
  26. 26. Think H1N1: Just because it is not in the media, it has NOT disappeared
  27. 27. Current Published CDC Guidelines <ul><li>Respiratory etiquette </li></ul><ul><li>Hand Hygiene </li></ul><ul><li>N-95 respirators for all direct patient contact if suspected/confirmed H1N1 </li></ul><ul><li>Prefer negative pressure room if performing aerosol-generating procedure </li></ul>
  28. 28. Current TDH Guideline <ul><li>Similar to WHO and Health Canada: </li></ul><ul><li>http://www.who.int/csr/resources/publications/infection_control/en/index.html . </li></ul><ul><li>For a ll patients with a febrile respiratory illness (FRI) (i.e., not just suspect or confirmed cases of H1N1): </li></ul>
  29. 29. Current TDH Guideline- All FRI: <ul><li>Practice good hand hygiene (patient and staff) </li></ul><ul><li>Practice good respiratory hygiene (patient and staff) </li></ul><ul><li>Practice standard precautions (i.e., treat all body-fluids as potentially infectious, including stool; wear gown, gloves and eye-protection if risk of splash) </li></ul>
  30. 30. Current TDH Guideline: All FRI <ul><li>Wear surgical mask if within 6 feet if: </li></ul><ul><ul><li>the patient is compliant (willing and able) with respiratory hygiene practices or </li></ul></ul><ul><ul><li>the patient has a weak or no cough </li></ul></ul><ul><ul><ul><li>individuals who may have a weak cough are the frail elderly and pediatric patients. </li></ul></ul></ul><ul><li>Wear a N-95 respirator (fit-tested); </li></ul><ul><li>Eye-protection (face-shield or goggles); </li></ul><ul><li>Gown and gloves </li></ul><ul><ul><li>IF conducting aerosol-generating medical procedures </li></ul></ul><ul><ul><li>OR </li></ul></ul><ul><ul><li>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) </li></ul></ul>
  31. 31. Current TDH Guideline <ul><li>Face-shields are preferred over goggles because: </li></ul><ul><ul><li>goggles may alter facial contours and impair the proper fit of N-95 respirators that were fit-tested without wearing goggles </li></ul></ul><ul><ul><li>face-shields are easier to clean than goggles </li></ul></ul><ul><li>Face-shields should cover the eyes and preferably extend over the chin </li></ul>
  32. 32. CDC Guidelines May Change <ul><li>APIC/SHEA position statement </li></ul><ul><li>HICPAC voted for following recommendation to CDC: </li></ul><ul><ul><li>Standard precautions </li></ul></ul><ul><ul><li>Droplet precautions </li></ul></ul><ul><ul><li>N-95 + Eye protection for aerosol-generating procedures </li></ul></ul><ul><li>Waiting for IOM report </li></ul><ul><ul><li>(8/11 meeting; report by 8/30) </li></ul></ul><ul><li>September 1: possible guideline change </li></ul>
  33. 33. Aerosol-Generating Procedures (HICPAC: 7/23/2009) <ul><li>Intubation </li></ul><ul><li>Bronchoscopy </li></ul><ul><li>Induced Sputum </li></ul><ul><li>Open Suctioning </li></ul><ul><li>CPR </li></ul>