1. Influenza Vaccine Supply 2005-06: Issues and Opportunities Raymond A. Strikas, M.D. National Immunization Program Coordinating Center for Infectious Diseases Centers for Disease Control and Prevention November 29, 2005

2. Planning for the 2005-2006 Influenza Season

3. Key Planning Stakeholders  DHHS (NVPO, CDC, FDA, CMS … )  State and local health officials  National Influenza Vaccine Summit  Influenza vaccine manufacturers

4. Supply-Based Scenarios 2005-06 Scenario Total doses LikelihoodActions Base63-71MModerate  Tough it out—no IND  Dual pre-book  Dual distribution  Prioritize vaccine Best >> 71M Most likely  Promote vaccine use Worst << 63M Unlikely  Prioritize vaccine  Activate insurance policy  Consider IND vaccine

5. Prioritization Recommendation Development  Last season, priorities developed in an emergency ACIP session  ACIP Influenza Working Group met in January to sub-prioritize for next season – Four work groups  Disease impact (Kathy Neuzil Lead)  Disease reduction from vaccination (Kristin Nichol Lead)  Herd Immunity (Arnold Monto Lead)  Economic aspects (Lisa Prosser Lead)  ACIP approved the sub-prioritization recommendations in February

6. ACIP Priority Groups for Influenza Vaccination, 2005-06 1a: <20 million persons  >65 years with medical conditions  Nursing home residents 1b: ~70 million persons  Persons 2-64 years with high risk conditions  Pregnant women  Persons without high risk conditions >65 years  Children 6-23 months old 1c: ~12 million persons  Health care workers  Close contacts to children <6 months of age 2: ~98 million persons  Contacts of all other high risk persons  Healthy persons 50-64 years 3: ~96 million persons  Healthy persons 2-49 years of age (everybody else)

7. Two-Tiered TIV Pre-Booking  Proposed by sanofi pasteur  Request # doses for targeted groups and total # of doses to purchase  Designed to allow public health considerations into vaccine sales

8. Vaccine Distribution  Predominant strategy has been multiple shipments of partial orders to all customers – Advantage: more vaccination early – Was important last season  When combined with two-tiered pre-booking, this strategy allows public health targeting into initial distribution – Initial distribution to targeted populations – May smooth distribution and allow targeted individuals first access to vaccine

9. Major Advances for the 2005- 06 Influenza Season  CMS – Significant increase in admin fee (> $18) – Requirement to offer vaccine to residents in LTCFs – Measurement of LTCF resident vaccination uptake (MDS)  FDA – Licensed GSK for U.S. influenza market – Worked with UK MHRA regarding Chiron’s remediation activities  CDC – Planning team meetings weekly – Pre-planned tiered approach to vaccination

10. 2005 Influenza Vaccination Season Timing Prioritization Until October 24, Followed by Open Vaccination, as Supplies Permit

11. Why start in a tiered system? Why October 24?  Programs need to plan clinics well in advance  Vaccine demand usually falls off after November, if not before  Balance competing priorities:  Offer vaccine to priority patients first  Try to use all vaccine available  Sufficient time to vaccinate priority patients and plan for vaccination of other patients

12. Influenza Vaccine Distribution, United States, 1999-2005

13. Influenza Vaccine Distribution, 2005-06  59 million doses distributed by Nov. 1  >80 million doses expected by Dec. 1  CDC received funds to purchase additional influenza vaccine doses for states to remedy shortfalls – 800,000 doses of inactivated vaccine from Chiron – 100,000 doses of nasal spray vaccine from MedImmune – Available in late November or early December  CDC VFC strategic reserve available in late December/early January – 3.5 million doses (sanofi) – 680,000 doses (Chiron) – 100,000 doses (MedImmune) – Use in non-VFC populations requires additional steps.

14. Problems with Vaccine Supply and Distribution - 1  Chiron projected 25m-30m doses’ production early in 2005, will produce <18 million  Orders for this vaccine were apparently solicited by distributors at the higher projections  Customers informed as early as late September that they would receive substantially less vaccine than ordered  Chiron’s vaccine distribution began in late October

15. Problems with Vaccine Supply and Distribution – 2  Many reports from physicians, community vaccinators, nursing homes, others of limited or cancelled orders  Some reports of delays with sanofi vaccine shipments  Concern about partial shipments being too small initially to permit clinic operations  Is demand for vaccine increased above expected levels?

16. Vaccine Supply Assessments  To understand better which providers, and to what extent, have been affected by supply problems, CDC and partners are surveying – Internists, pediatricians, family physicians (AAFP) – Local public health (NACCHO) – State and local immunization grantees – Community, occupational, and pharmacy vaccinators (National Influenza Vaccine Summit, American Pharmacists Association) – Hospitals (AHA) – Federally qualified health centers (NACHC, HRSA) – The public (Gallup)

17. Preliminary Results – Physicians’ and Pharmacists Surveys Pediatricians11/17/05 General Internists 11/17/05Pharmacists11/14/05 Response rate 132/283 (47%) 127/308 (41%) 252/3493 (7%) Ordered from sanofi 76%41%59% Ordered from distributor – Chiron or unknown 21%43%22% Received >40% order 76%60%68% Received >80% order 51%35%54% Referred patients to MD office, other clinic 50%68%100%

18. Preliminary Results – Federal Immunization Grantees’ Survey, 11/28/05  45/64 (70%) responded  25/43 (58%) ordered from sanofi (2 ordered no vaccine)  4/43 (9%) ordered from distributor – Chiron or unknown  42/43 (99%) received >40% order  39/43 (91%) received >80% order  All have received complaints about vaccine supply  36/45 (80%) addressing redistribution by sharing information and/or vaccine

19. Recommendations for Providers with Limited Vaccine, 11/18/05  If not already done, contact distributor, manufacturer, pharmacy or other entity from which you ordered vaccine to understand how many doses you will receive and when.  Target vaccine toward priority patients unless you have sufficient doses to broaden your vaccination efforts to non-priority patients.  Contact your local or state public health agency to see if they are aware of facilities or clinics that may be available to serve priority patients in your community or if you have influenza vaccine that you feel may go unused.  If you anticipate having vaccine in December, remind your patients that vaccination in December and beyond is still beneficial, especially since influenza activity usually does not peak in the U.S. until January or later.  Consider the nasal spray vaccine (FluMist) for patients (priority and non-priority) for whom this vaccine is indicated, healthy, non- pregnant persons aged 5-49.

20. Next Steps  Review surveys’ data once complete  Share with partners  National Influenza Vaccine Summit meeting Jan. 24-25, 2006  Develop recommendations for vaccine ordering, distribution for 2006

22. Questions?