1. Influenza Vaccine Supply and Distribution: An Overview of the 2004-2005 Season Jeanne M. Santoli, MD, MPH National Immunization Program

2. The Bad News

4. The Good News

5. Adult Influenza Vaccination Coverage September – December 2004 BRFSS, 2005* (n = 19,091) Populationn% 95% CI † Aged 18-64y, high-risk § Aged 18-64y, high-risk § 2,669 2,66928.0 ± 3.5 Aged ≥65y Aged ≥65y 4,747 4,74758.9 ± 2.9 Health-care workers Health-care workers with patient contact with patient contact 1,204 1,20442.6 ± 5.6 Priority adults ¶‡ 8,454 8,45443.1 ± 2.1 Nonpriority adults 10,637 8.3 8.3 ± 1.6 *Interviews conducted January 2-22, 2005 † Confidence interval § Asthma; other lung, heart, or kidney problems; diabetes, weakened immune system, anemia, or pregnancy ¶ Persons can be included in more than one priority group. ‡ Includes persons in households with children aged <6m.

6. Child Influenza Vaccination Coverage September – December 2004 BRFSS, 2005* (n = 4,424) Populationn % 95% CI † Aged 6-23m Aged 6-23m 403 40357.3 ± 9.0 Aged 2-17y, high-risk § Aged 2-17y, high-risk § 478 478 43.8 43.8 ± 10.0 Priority children 881 881 50.7 50.7 ± 6.7 Nonpriority children ¶ 3,543 12.4 12.4 ± 2.6 *Interviews conducted Jan 2-22 † Confidence interval § Asthma; other lung, heart, or kidney problems; diabetes, weakened immune system, anemia, or aspirin therapy. ¶ Includes persons in households with, and out-of-home care givers of, children aged <6m, and others with rare high-risk conditions.

7. Influenza Vaccine Supply 2004-05  With the announcement that Chiron would not be able to supply the US market – US licensed vaccine supply decreased by ~50% – More than 50% of the remaining supply of inactivated vaccine already distributed to approximately 34,000 customers – Distribution primarily by sanofi pasteur (formerly Aventis Pasteur), using partial shipments

8. Doses of sanofi pasteur TIV Distributed Before 10/5/04

9. One Approach to Allocating a Scarce Resource

10. Immediate Actions Taken  ACIP provided interim recommendations on October 5 identifying priority groups – Number of persons recommended for vaccination drops from 188 million to 98 million  Sanofi pasteur voluntarily ceased shipment of vaccine, began discussions with CDC  FDA authorized redistribution of influenza vaccine  State/local public health officials redistributed vaccine, identified sites for vaccination of high risk persons, reduced inappropriate use of vaccine, sub prioritized vaccine use as needed

11. Efforts to Augment Supply  Sanofi pasteur freed up additional doses by reaching out to large customers with outstanding orders and produced 2.6 million additional late season doses  MedImmune increased production from 1 million doses to 3 million doses  DHHS contacted several foreign manufacturers of influenza vaccine to inquire about obtaining vaccine to supplement US vaccine supply under an Investigational New Drug (IND) protocol

12. Tracking the Location of Vaccine  Detailed proprietary information about vaccine shipments – Sanofi pasteur provided vaccine shipment information – Vaccine distributors provided pre-booked orders and vaccine shipment information  Information on CDC’s Secure Data Network (SDN), accessible to state health officials or designees  SDN also used by states to place vaccine orders for their jurisdictions

13. Vaccine Distribution: An Iterative Process Objective: To distribute a scarce resource to the providers most likely to be able to reach priority patients. 1. Immediately identifiable orders 2. Apportioned vaccine doses 3. Late season strategies

14. Inactivated Vaccine Supply Status October 5, 2004 ~25 million doses ~33 million doses

15. Identifiable Orders  Allowed vaccine distribution to resume quickly  Included many public health orders placed with Chiron  Orders selected for full or partial filling included: – State/local public health departments – Long term care facilities/hospitals – VA/IHS/DoD – Providers who care for children (VFC orders, p-free orders, office-based pediatricians) – Community immunization providers/VNAA – Office-based primary care providers  Approximately 13 million doses distributed during October-early December

16. Inactivated Vaccine Supply Status Early November 2004 ~12 million doses ~46 million doses

17. State/Local Public Health Officials  Pivotal role – Relationships with providers, facilities (including licensing) – Emergency powers – Vaccine redistribution activities  Knowledgeable about local supply/demand situation  Best suited to identify and address gaps in vaccine distribution

18. Apportioned Vaccine Doses  ~3.5 million doses filled remaining identifiable public health orders  ~8.5 million doses apportioned across states according to unmet need formula  Formula developed collaboratively by state and local health officials and CDC – Based upon a state’s “share” of unmet national need – Unmet need = # of priority persons- total doses delivered  Three re-apportionments to redirect vaccine  States allocated vaccine across providers from November 9, 2004 to mid January 2005

19. Broadened Recommendations: December 2004  ACIP reviewed data about vaccine supply and coverage  Recommendations broadened to include those aged 50-64 and household contacts at discretion of state/local public health – Effective date: January 3, 2005  VFC resolution broadened to include household contacts – Effective date: Immediately

20. Inactivated Vaccine Supply Status Mid January 2005 ~3.5 million doses ~54.5 million doses

21. Late Season Strategies: Announced 1/27/2005  CDC encourages states to – Continue to target high risk individuals – Broaden administration of vaccine to make most effective use of existing supply  Stockpile strategy – Sanofi pasteur distributes doses with a return policy to minimize financial risk to providers  VFC transfer strategy – Limited amounts of VFC vaccine transferred to state health departments in jurisdictions in which the need for VFC vaccine among eligible children has been met

22. Vaccine Production and Distribution: How Does 2004 Compare with Prior Seasons? Year Doses Produced in millions Doses Distributed in millions (%) 199977.2 76.8 (99%) 200077.9 70.4 (90%) 200187.7 77.7 (89%) 200295.0 83.0 (87%) 200386.9 83.1 (96%) 200461.0 56.5 (93%) Data provided by vaccine manufacturers No data are available on how many doses of influenza vaccine are administered each year.

23. Lessons Learned  Collaboration/communication between and among private and public sector partners was critical – Public/private – Public/public – Private/private  Alignment of roles during a crisis with routine responsibilities and authorities maximized accomplishments  Real-time data supported management of the public health response  Evaluation activities enhanced decision-making  Optimal ways to ensure a reliable vaccine supply of influenza vaccine require additional thinking and analysis – Stockpile versus ability to expand production capabilities on short notice versus other options – Stabililizing/increasing demand for vaccination and extending the vaccination season – Increasing the number of licensed manufacturers to provide flexibility in the event of unexpected supply disruptions

24. Conclusions  When it comes to influenza, disease, supply, and demand for vaccination are highly unpredictable  This influenza season represented a difficult situation with a number of important positive outcomes – Relatively high vaccine coverage among priority groups – Evidence of successful targeting of vaccine – Forging and strengthening of alliances that will be valuable in the future  Timeliness of decision-making and implementation is critical—an opportunity for continued improvement  This year’s experience underscores the importance of planning for future seasons – Start early – Anticipate multiple scenarios – Involve key stakeholders

25. A Word of Thanks Any successes that can be claimed rest upon the shoulders of more individuals and groups than can be named – Individuals who stepped aside to save vaccine for persons in priority groups – Private providers – State/local public health officials – Sanofi pasteur – MedImmune – Vaccine distributors – FDA and other federal agencies