# Presentation: 057603

**Notes:**
agenda

## Agenda

- Overview of Influenza Vaccine Production and Development
- Vaccine Supply/Demand: Recent Trends
- Recommendations to Increase Influenza Vaccine Demand

## 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 2003-2004 season

## Production Follows Proven Multi-Step Process

| 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**

## Manufacturing Timeline Overview

## Projected Supply for US Market

- 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**

## II. Vaccine Supply/Demand Environment: Recent Trends

- 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**

**Notes:**
In 2002, 95 million doses were manufactured for the US market.  Approximately 10-12 million were discarded by manufacturers and another 10 million were estimated to be discarded in the field. 

## 2003-2004 Season Summary 

- 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

**2003-2004 Season Summary**** **

**Notes:**
In December, AvP offered CDC additional doses

## Preparing for 2004-2005 Influenza Season 

- Pre-orders drive vaccine production (2004-2005)
- -Demand drives supply over time
- -2004-05 Pediatric Recommendation (1st season)
- Pre-Book Vaccine Orders for 2004-2005 season began December 1st, 2003
- Planning early assists all stakeholders (Public and Private)
- -To increase immunization across all risk groups (HP2010)

**Preparing for 2004-2005 Influenza Season**** **

## Meeting Public/Private Demand

- 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**

## The Influenza Vaccine Market is Increasingly a Private Purchase System

**Panama Strain*

- E**stimated 83-87 million total doses**

***Public - Private Demand***

**The Influenza Vaccine Market is Increasingly a Private Purchase System**

- *

- 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**

- 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**

## III. 	Aventis Pasteur Principles: Increasing Influenza Vaccine Demand to meet HP2010

- National Awareness/Educational Campaigns: Better coordinate public education and awareness campaigns to deliver core messages
- 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**

## III. 	Aventis Pasteur Principles: Increasing Influenza Vaccine Demand to meet HP2010

- 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**

## III. 	Aventis Pasteur Principles: Increasing Influenza Vaccine Demand to meet HP2010

- 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**

## Aventis Pasteur: Final Points

- 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 2004-2005 season

**Aventis Pasteur: Final Points**