# Presentation: 037902

## Influenza Vaccine Supply for 2004-05: The Challenge 

**Raymond A. Strikas, M.D.**
**Lance E. Rodewald, M.D.**
**Jeanne M. Santoli, M.D., M.P.H.**
**Stephen L. Cochi, M.D., M.P.H.**
**National Immunization Program, CDC**

## Influenza Program Plans Before October 5, 2004

**Season’s assets**
**Aggressive ACIP recommendations **
**Record number of doses**
**Enhanced interest in influenza**
**Season’s challenges**
**Using all doses produced**
**Fulfilling VFC entitlement**
**Coverage disparities**

## Inactivated Influenza Vaccine Distribution Practices

**Chiron**
**Through 7 distributors**
**Aventis Pasteur (AvP)**
**Approximately 85% direct to end-users**
**Partial shipments ******** all customers**

## Status of Inactivated Influenza Vaccine Distribution on October 4

**Chiron**
**Distribution on hold**
**Expected to provide nearly all projected  doses (46-48 million)**
**Anticipated date of approval to begin shipping:  October 5**
**Aventis Pasteur**
**Distribution on schedule**
**Almost all customers had some vaccine**

## TIV Status on October 5

**33 M AvP doses distributed**
**Providers of all types had vaccine**
**Those serving low risk individuals**
**Those serving high risk individuals**
**Over 30,000 providers had AvP vaccine**
**Zero Chiron doses distributed; Chiron announced that**
**Their license suspended for 3 months**
**No doses available for 2004-05**

## Expected Pattern of TIV Distribution On October 5

**Gap in distribution for customers who pre-booked orders with Chiron**
**Large scale geographic disparities unlikely since both companies served all regions**
**Extreme dichotomization of distribution most pronounced at local level**

## Immediate Steps Taken

**Aventis Pasteur (AvP) halted shipment of their remaining 22 M doses**
**ACIP met in emergency session to reduce the targeted groups**
**185 M overall ******** 98 M**
**20 M children ******** 9 M children**
**CDC and AvP began formulating an allocation plan for remaining inactivated influenza vaccine**

## Priority Groups For Influenza Vaccination, 2004-2005 (I)

**Children 6-23 months of age**
**Adults **_**>**_**65 years **
**Persons 2-64 years of age with underlying chronic medical conditions, including HIV/AIDS **
**Women who will be pregnant during influenza season **

***MMWR***** 2004;53(39);923-4**** **

## Residents of nursing homes and long-term care facilities 
Children 6 months-18 years of age on chronic aspirin therapy 
Healthcare workers with direct, hands-on, face-to-face patient contact
Household contacts and out-of-home caregivers of children aged <6 months
All groups deemed equal; no subprioritization by CDC, ACIP

**Children 6 months-18 years of age on chronic aspirin therapy **
**Healthcare workers with direct, hands-on, face-to-face patient contact**
**Household contacts and out-of-home caregivers of children aged <6 months**
**All groups deemed equal; no subprioritization by CDC, ACIP**

**Priority Groups For Influenza Vaccination, 2004-2005 (II)**

## Healthy* persons 5–49 years of age 
Household contacts of persons at increased risk of complications of influenza; for 2004-05, just those <6 months of age

Health care workers, including those who care for HIV/AIDS patients, if those patients are not in protective isolation

**Household contacts of persons at increased risk of complications of influenza; for 2004-05, just those <6 months of age**
**Health care workers, including those who care for HIV/AIDS patients, if those patients are not in protective isolation**

**Live Attenuated Influenza Vaccine (LAIV) Indications**

- * Persons who do not have medical conditions that increase risk of complications of influenza

## Public Health Challenge

**Allocate 22 M doses as well as possible to fill the critical distribution gaps**
**Facilitate community efforts**
**Redistribute vaccine**
**Identify providers for targeted individuals**
**Reduce inappropriate vaccination**
**Make effective use of LAIV**
**Identify any other sources of vaccine**

## Influenza Vaccine AllocationGoal and Approach

**Goal: Distribute a scarce resource to the providers most likely to be able to reach priority patients.**
**Two-phased approach**
**National level efforts to allocate vaccine quickly to providers serving priority groups (Phase I)**
**State and local public health efforts to guide allocation efforts later in the vaccination season based on information about unfilled orders, local supply, and number of priority persons  (Phase II)**

## Two-phased Approach

**Phase I:  Orders that were immediately identifiable on October 5, 2004**
** ****Phase II:  Orders that required identification and enumeration **
**Separation into two phases allowed resumption of shipping to begin reaching ACIP priority groups as quickly as possible**

## Orders Filled in Phase I (I)

**Approximately 13.5 million doses**
**Filled in total**
**Vaccines For Children (VFC) orders**
**Orders for preservative-free influenza vaccine from Aventis (young children)**
**Veterans Affairs/Indian Health Service orders placed via federal VA contract**
**Long term care facilities/hospitals ordering directly from Aventis**
**Aventis orders from pediatricians**

## Approximately 13.5 million doses

Filled in part
Public health orders placed via federal, state or multi-state contracts
Doses ordered by the VNAA
Doses ordered by mass vaccinators
Doses ordered by the military
Doses ordered from Aventis by primary care providers/specialists

**Filled in part**
**Public health orders placed via federal, state or multi-state contracts**
**Doses ordered by the VNAA**
**Doses ordered by mass vaccinators**
**Doses ordered by the military**
**Doses ordered from Aventis by primary care providers/specialists**

**Orders Filled in Phase I (II)**

## Planning for Phase II Allocation:  National Activities (I)

**Canvassed orders placed with a Chiron distributor conducted collaboratively by CDC, AvP, and the Chiron distributors**
**Conducted long term care facility survey (CDC, Aventis, long term care partners) to better  understand the supply chain to these facilities**
**Brought together data collected by other groups, such as IHS facilities, federally qualified health centers, large dialysis organizations.  **

## Identify and reach out to distributors to participate in phase II vaccine distribution
Develop procedures for vaccine distribution in phase II 
Hold conference calls with stakeholders, including state/local public health officials, private providers, long term care facility partners, hospital partners, business groups, colleges, etc.
Use Flu Vaccine Finder:  Secure database of doses distributed available via the Internet to state health officers

**Develop procedures for vaccine distribution in phase II **
**Hold conference calls with stakeholders, including state/local public health officials, private providers, long term care facility partners, hospital partners, business groups, colleges, etc.**
**Use Flu Vaccine Finder:  Secure database of doses distributed available via the Internet to state health officers**

**Planning for Phase II Allocation:  National Activities (II)**

## Phase II Allocation

**Approximately 10.6 million p-containing doses, including 2.6 million “late season” vaccine (January 2005)**
**Began with shipment of remaining public health doses on federal, state, and multi-state contracts (approximately 3.4 million doses)**
**Includes state apportionment (7.2 million doses) to be allocated by states using the existing supply chain or purchased directly**
**Includes an additional 1.3 million preservative-free doses, also apportioned across states for allocation**

## Phase II Allocation Formula (I)

**Total number priority persons in a state:  estimated by census data, prevalence estimates for medical conditions **
**Number of doses already delivered to the state through phase 1, subtracted from the total number of doses needed for all priority persons = state’s estimated unmet need. **
**Add all estimates of states’ unmet needs to estimate  national unmet need. **
**A state’s allotment of doses will be determined by dividing that state’s unmet need estimate by the national unmet need estimate, then applying the percentage to 7.2 million doses**** **

## Example:  
State A has 100,000 priority persons
Has received 50,000 doses to date, then
Unmet need = 50,000 doses

If the national unmet need is 50,000,000 doses, then 50,000/50,000,000 = 0.001.

State A’s unmet need represents 0.1% of the national unmet need.  State A would thus be allocated 8,500 doses (0.001 x 8,500,000).  

**State A has 100,000 priority persons**
**Has received 50,000 doses to date, then**
**Unmet need = 50,000 doses**
**If the national unmet need is 50,000,000 doses, then 50,000/50,000,000 = 0.001.**
**State A’s unmet need represents 0.1% of the national unmet need.  State A would thus be allocated 8,500 doses (0.001 x 8,500,000).  **

**Phase II Allocation Formula (II)**

## Timeline (I)

**Shipping resumed in the second week of October and is anticipated to continue through December 19, again in January**
**Shipment of Phase I orders completed in the last week of October; shipment of Phase II orders began during the first week of November  and will continue through January.**

## Timeline (II)

**Total weekly shipments of ~ 3 million doses**
**All large orders are filled with partial shipments**
**Late season vaccination (through January) will be necessary**

## If you don’t yet have vaccine ...

**Let the state or local health department know you need vaccine and how much; check their websites which may contain guidance, or permit you to inform them**
**State or local health departments will inform providers if they **
**will receive public purchased vaccine, **
**are to purchase allocated vaccine, or**
**should send patients to other sites for vaccination**

## Other Influenza Vaccines

**MedImmune – approximately 3 million FluMist****®**** doses to be available; can be used in two priority groups but isn’t limited to those individuals**
**Vaccine from other countries may be available as early as mid-December**
**FDA and CDC are exploring the options**

## Monitoring

**BRFSS weekly surveys for vaccine coverage**
**Vaccine safety through VAERS**
**Disease surveillance systems**

## Slide 26

## How Can Vaccine Shortages Be Prevented?

**Expansion of vaccine strategic reserves**
**Add new manufacturers; financial incentives for manufacturers?**
**National campaign to emphasize benefits/value of vaccines**
**Maintenance/strengthening of liability protections**
**Increased support for regulatory agencies**
**Streamline regulatory process**