# Presentation: 713394

## Preview of the 2004-2005 Influenza Season:Programmatic Challenges and Opportunities

**Jeanne M. Santoli, MD, MPH**
**National Immunization Program**

## Overview

**Timeline**
**Challenges**
**New recommendation**
**Vaccine supply**
**Opportunities**
**Potential “spillover” benefits of expanded pediatric influenza immunization**
**Next steps**

## 2004-05 Timeline

**December 2003:****  ****	****“Pre-booking” for influenza vaccine ****	****	****	****began (non-CDC orders)**
**March-May 2004:****  ****	****Federal influenza vaccine contracts ****	****	****	****negotiated**
**May 2004:****  ****	****	****Federal immunization grantees ****	****	****	****	****began placing vaccine orders**
**August 2004:****	****ACIP to make assessment of need ****	****	****	****for tiered vaccination**
**September 2004:****	****Vaccine delivery and vaccination ****	****	****	****typically begin.   **
**March 2005:****  ****	****Vaccination season ends**

## Primary Changes/Updates to Influenza Recommendations

**Annual vaccination of healthy 6-23 mo children and close contacts of those aged 0-23 mo. **
**Inactivated vaccine preferred over LAIV for close contacts (includes HCWs) of  severely immunosuppresssed persons in the 7 days following vaccination.**
**Severely immunosuppressed persons should not administer LAIV.**
**2004-05 trivalent vaccine strains: **
**A/Fujian/411/2002 (H3N2)-like,                          **
**A/New Caledonia/20/99 (H1N1)-like, **
**B/Shanghai/361/2002-like**
**CDC and other agencies will assess vaccine supply during the manufacturing period and make recommendations in the summer about the need for tiered vaccination.  **

**Source:  CDC.  Prevention and Control of Influenza.  MMWR 2004; 53:1-40.  **

## Pediatric Influenza Vaccination—What is the Baseline?

**9-10% --**** children 1-6 years with asthma in 4 large HMOs during 1995-1996; 61% of unvaccinated children had a missed opportunity--visit between 9/1 and 12/31/95 ****(Kramarz, 2000)**
**7-9% --**** children 2-16 years with asthma who were enrollees in NY CHIP plan ****(Szilagyi, 2000)**
**31% --**** hospitalized children 6mo-18 years with high risk conditions ****(Poehling, 2001)**
**25% -- ****children with mod-severe asthma in an allergy/immunology clinic ****(Chung, 1998)**
**80% --**** children 6mo-18 years with cystic fibrosis (CF) at a CF center in Utah during 1997-98          ****(Marshall, 2002)**
**No national data exist**

## Feasibility Studies:  How Long Does it Take to Vaccinate?

**   ****Szilagyi, et al 2003****  Time and motion study of 92 influenza vaccinations during vaccine-only visits in 7 primary care practices in Rochester, NY during 2000-01 influenza season**
**Key findings**** **
**Influenza vaccination and total visit times had median values of 2 minutes and 14 minutes, respectively**
**80% patient time spent waiting (exam room + waiting areas)**
**Vaccinating 100 children would require 13 hours (4 half-day sessions), 12 hours of additional staff nurse time, and 10 minutes of physician/nurse practitioner exam time**
**Recommendations****  Consideration of influenza vaccination sessions, extended hours**

## Feasibility Studies:  Visits Needed

**Szilagyi, et al 2003****  Analysis of insurance claims from 3 influenza seasons (1998-2001) by 6-23 month olds in 5 managed care plans (commercial and Medicaid) in upstate NY**
**Assumption:  vaccination during Oct-Dec**
**Key findings****  **
**74% of children need  1 or more additional visit(s) if only well visits used**
**46% of children need 1 or more additional visit(s) if all visits are used**
**Longer vaccination seasons resulted in less children needing additional visits**
**Recommendations  ****Consideration of longer vaccination season, use of all visits for vaccination**

## Ongoing Intervention Studies, I

**Zimmerman, et al  ****Intervention study in 9 inner city health centers in Allegheny County, PA.  Provider education and technical assistance on determining eligible patients and implementing interventions**
**Key findings  **
** ****Influenza vaccine coverage (first dose) **
**Pre-intervention :  0-8%**
**Post-intervention :  15-49%**
**Coverage with other vaccines not adversely affected**

## Ongoing Intervention Studies, II

**Kempe, et al****  RCT trial of registry-based recall for influenza vaccination of healthy 6-21 month old children in 5 private practices in Denver during the 2003-04 influenza season**
**Influenza vaccine coverage among intervention groups ranged from 44-75%**
**As of 12/31/03**
**Intervention group:  60.4%**
**Control group:  55.9%**
**Intervention – control:  4.5% (p = 0.001)**
**Prior to publicity about epidemic**
**Intervention – control:  9.3% (p < 0.0001)**

## Evaluation Questions 

**	****Nearly a dozen studies about influenza vaccination in children 6-23 mo are planned or underway to assess:**
**vaccine effectiveness and impact **
**vaccination coverage**
**location and timing of vaccination   **
**“****prevalence” of provider recommendation to parents **
**barriers faced by providers during the 2003-04 influenza season**
**parental reasons for declining vaccination**
**burden of hospital-acquired influenza infections among children**

## Vaccine Supply

**Estimation of demand for vaccine during 2004-05 influenza season are complicated by**
**Unknown impact of experiences during the 2003-04 influenza season**
**Variation in vaccine formulation preferences**
**Thimerosal**
**Reduced yield of preservative-free vaccine**

## Influenza Vaccine Doses Produced for the U.S. Market, 1999-2003*

| Year | Doses Produced (millions) | Doses Distributed (millions) |
| --- | --- | --- |
| 1999 | 77.2 | 76.8 |
| 2000 | 77.9 | 70.4 |
| 2001 | 87.7 | 77.7 |
| 2002 | 95.0 | 83.0 |
| 2003** | 86.9 | 83.1 |

***Data provided by vaccine manufacturers**
****Estimated; includes both inactivated and live vaccines**

**Notes:**
This table documents the total number of influenza vaccine doses produced and distributed in the United States since 1999.  CDC thanks our colleagues at the vaccine companies for working with us to provide these data in a regular and timely way.  You see that total production has exceeded 77 million doses each of these years, peaking at 95 million in 2002.  More importantly, the net doses distributed peaked last year at 83.1 million, just over the 83 million in 2002.  The 2003 doses included both inactivated and live attenuated vaccine.  As I will discuss, virtually all the inactivated vaccine was distributed last year, with the bulk of that not distributed being live attenuated vaccine.

## 2004-05 Federal Influenza Vaccine Contracts

| Manufacturer | Product name | Formulation | Dose price | Contract maximum |
| --- | --- | --- | --- | --- |
| Aventis Pasteur | Fluzone® | Preservative-free
(6-35 mo) | $10/0.25 mL dose
(single dose syringe) | 3 million doses |
| Aventis Pasteur | Fluzone®
 | Preservative-containing
(6+  months) | $6.80/0.5 mL dose 
(multi-dose vial) | 3 million doses |
| Chiron | Fluvirin® | Preservative-containing
(4 + years) | $7.54/0.5 mL dose
(multi-dose vial) | 750,000 doses |

## CDC actions 

**Pre-season **
**Develop estimates of grantee need**
**Monitor grantee orders**
**Hold orders for preservative-containing influenza vaccine with state dollars**
**Talk with manufacturers about modifying contract maximums**
**Develop allocation plan**
**During the season**
**Work with manufacturers and distributors to track supply on a weekly basis**

## Influenza Vaccine Stockpile

**VFC funds**
**$40 million dollars in the FY 2004 budget**
**$40 million dollars requested in the FY 2005 budget**
**Mix of inactivated vaccine products**
**Contracting process underway**
**NIP/NCID working to develop “release models” **

## Opportunity: Growing the Influenza Vaccine Market 

| Group | Population (millions)
     2001-02         2002-03 |  |
| --- | --- | --- |
| Adults > 65 y | 35.4 | 35.6 |
| Adults 50-64 y (excluding high risk persons) | 19.6 | 20.1 |
| High risk person 6 mo-64 y  | 39.2 | 39.7 |
| Pregnant women | 2 | 2 |
| Healthy children aged 6-23 m | 0 | 5.9 |
| Household contacts | 62.2 | 75.5 |
| Health care personnel < 65 y | 7 | 7 |
| Total target groups | 165.4 | 185.8 |

**Source:  James Singleton, NIP/CDC**

## Opportunity:  Changing the Culture

**Link with routine childhood immunization**
**Potential to address misperceptions of vaccine safety**
**Increased awareness of importance of parental vaccination to protect young children**

## Themes from the 2004 Influenza Summit (Atlanta, GA)

**Develop a crisis plan, including monitoring vaccine supply at levels lower than the manufacturer**
**Create year-long, coordinated approach to influenza communications**
**Continue efforts to improve influenza vaccine uptake for current risk groups and extend vaccination season when appropriate**
**Improve health care worker vaccination rates**
**Advocate for public/private funding for influenza vaccination, particularly for under/uninsured adults**
**Consider a broader concept of influenza prevention as part of Summit activities**
**Explore universal vaccination**

## Acknowledgements

**Carolyn Bridges**
**Rex Ellington**
**Marika Iwane**
**Dennis O’Mara**
**Donna Rickert**
**Lance Rodewald**
**Jim Singleton**
**Nicole Smith**
**Ray Strikas**
**Anjella Vargas-Rosales**
**Greg Wallace**
**Rick Zimmerman**