1 NVAC Washington, D.C. February 3, 2004

2 Agenda I.Overview of Influenza Vaccine Production and Development II.Vaccine Supply/Demand: Recent Trends III.Recommendations to Increase Influenza Vaccine Demand Influenza Vaccine Supply/Demand

3 Aventis Pasteur globally accounts for approximately 50% of world’s influenza vaccine supply Plant in Swiftwater (PA) manufactures 50% of the US influenza vaccine supply Additional manufacturing, filling and packaging (2006) is planned Cell culture work is progressing Aventis Pasteur shipped approximately 43 million doses in season I. Overview: Aventis Pasteur Influenza Vaccine Production

4 CDC provides seed virus to FDA Jan-May FDA provides strains to manufacturers Seed virus injected into fertilized chicken eggs Incubation for several days to allow virus to grow Eggs are opened and allantoic fluid is removed to harvest virus Multiple purification steps Virus is inactivated FDA test each strain for correct virus Jun-Aug Tested for purity and potency 3 strains are formulated into a single vaccine Vaccine is filled into vials/syringes Aug-Dec Product packaging Product is licensed by FDA one lot at a time Final product released by manufacturer Product distribution begins Production Follows Proven Multi-Step Process

5 Manufacturing Timeline Overview

6 Industry estimated capacity for upcoming year ( ): M doses of trivalent vaccine by first week of November* (depending on strain yield) Total vaccine available in the US has doubled in last 10 years to meet/exceed market demand Capacity could expand further, but demand drives supply Additional supply could be made available in late November/December * Based on corporate announcements Projected Supply for US Market

7 In 2002, insufficient demand resulted in manufacturers discarding 12 million doses intended for US market Vaccine orders in 2003 were down significantly, indicating demand would be less than in the prior season Production based on pre-book vaccine orders plus “at risk” allowance In 2003, early influenza outbreaks created unanticipated vaccine demand after production was finalized. II. Vaccine Supply/Demand Environment: Recent Trends

8 Ample supply existed in Q3, 2003 (83-87M + doses) Unanticipated demand late November/December exhausted supplies Aventis Pasteur proactively notified CDC of late surge Worked with CDC to reserve/allocate vaccine to states Aventis Pasteur offered CDC remaining doses: - 100,000 additional doses of Fluzone® - 150,000 doses of Fluzone®, Pediatric P-Free Influenza Vaccine Season Summary

9 Pre-orders drive vaccine production ( ) -Demand drives supply over time Pediatric Recommendation (1 st season) Pre-Book Vaccine Orders for season began December 1 st, 2003 Planning early assists all stakeholders (Public and Private) -To increase immunization across all risk groups (HP2010) Preparing for Influenza Season

10 Aventis Pasteur US developed equitable allocation and distribution policy in coordination with public health and medical authorities In US, 85% of influenza vaccine doses sold, distributed and administered in private market Aventis Pasteur US provides nearly 70% of influenza vaccine that the public sector purchases Meeting Public/Private Demand

11 Source: Aventis Pasteur Estimates *Panama Strain Estimated million total doses Public - Private Demand The Influenza Vaccine Market is Increasingly a Private Purchase System *

12 Build upon existing system: Current private-public distribution system is efficient Promote provider and consumer education about influenza immunization recommendations Encourage health care providers to order vaccine early Develop innovative and sustainable initiatives to drive demand Urge Health Care workers to set an example for immunization Key Lessons on Influenza Vaccine Supply

13 Demand for influenza vaccine drives increased supply Steady, predictable annual increases in demand will ensure increased capacity to meet immunization goals. Key Lesson on Influenza Vaccine Supply

14 1.Best Practices: Promote strategies that providers can use as models for successful immunization campaigns 2.National Awareness/Educational Campaigns: Better coordinate public education and awareness campaigns to deliver core messages a)Correct misinformation about immunization b) Adult Immunization Coalitions: Provide funding for coalitions c) Year-Round Approach: Work with physicians and providers to ensure year-round immunization planning III. Aventis Pasteur Principles: Increasing Influenza Vaccine Demand to meet HP2010

15 3.Utilize synergy of HHS agencies: NVPO: Forge public/private partnerships CDC: Gather/publish immunization rates and enhance public confidence in vaccines CMS: Inform Medicaid/Medicare providers about importance of pre-ordering vaccine CMS: Publish timely reimbursement notice regarding fees FDA: Ensure public confidence in safety and efficacy III. Aventis Pasteur Principles: Increasing Influenza Vaccine Demand to meet HP2010

16 4.Extend Immunization Season 5.Increase immunization rates of health care professionals 6.Insurers/Managed Care: Agree to cover influenza; encourage pre-ordering; and educate at risk patients 7.Strategic Reserves: Ensure vaccine available in the event of unanticipated demand/outbreaks III. Aventis Pasteur Principles: Increasing Influenza Vaccine Demand to meet HP2010

17 Optimal solution to achieve HP 2010 goals and pandemic preparedness is to increase annual immunization rates Increased demand will drive increased supply Short Term: Aventis Pasteur plans under review to expand egg-based capacity Long Term: Aventis Pasteur is working on innovative cell culture approaches Strategic Reserves: Immediately begin planning for shared-risk reserves for surges if influenza vaccine is to be available for season Aventis Pasteur: Final Points