# Presentation: 063898

## National Immunization 
Program (NIP) Overview

Stephen L. Cochi, MD, MPH
Acting Director, National Immunization ProgramCenters for Disease Control and Prevention
National Vaccine Advisory Committee
June 2004

**Program (NIP) Overview**
**Stephen L. Cochi, MD, MPH**
**Acting Director, National Immunization Program****Centers for Disease Control and Prevention**
**National Vaccine Advisory Committee**
**June 2004**

## Successes- 2004 - 

## Expansion of Hepatitis A Vaccine Recommendations

*Source:*
- Anthony Fiore
- Division of Viral Hepatitis
- National Center for Infectious Diseases

**Notes:**

Good afternoon. I will start by saying that I will disappoint those of you who expected to see an unveiling of new recommendations today. We don’t in fact have any new recommendations in the pipeline. I don’t know where this title came from.  But I think I can work with it, just by adding a single punctuation mark. 

## Incremental Implementation of Routine Hepatitis A Vaccination of Children

**1996 - Children living in “high rate” communities**
**American Indian, Alaska Native, selected Hispanic, migrant, and religious communities**
**1999- Children living in states/ communities with consistently elevated rates during “baseline period” (1987-1997)**
**All children nationwide (?)**

**Notes:**
In 1996, vaccination was recommended for children living in high rate communities, including those listed here. When programs were started in these communities, they were often very successful. But we saw little impact of this policy on overall US rates because these groups accounted for a small proportion of cases nationwide.  

## Number of Years Reported Incidence of Hepatitis A Exceeded 10 Cases per 100,000, by County, 1987-1997

**Notes:**
Now, we knew that hepatitis A incidence was highest in certain regions of the country. In this county map, regions whose rates usually exceeded the national incidence rate over an 11 year period, referred to as the baseline period, are in red, orange or yellow. These areas accounted for a majority of cases nationwide during that time.

## 1999 ACIP Recommendations for Statewide Routine Hepatitis A Vaccination of Children*

**Rate **_**>**_** 20/100,000**
**Recommended**

**Rate 10-20/100,000**
**Considered**

**Rate < 10/100,000**
**Not statewide**

- * Based on average incidence rate during baseline period (1987-1997)

**1999 ACIP Recommendations for Statewide Routine Hepatitis A Vaccination of Children***

**Notes:**
Routine vaccination was recommended for children living in states shown in red on this slide, and the ACIP suggested that routine vaccination be considered for children living in states shown in yellow. During the baseline period of 1987-1997, before the recommendations were made, about two thirds of all hepatitis A cases were reported from residents of these states, even though these states are home to < one third of the US population.  No statewide routine vaccination was recommended for children living in the rest of the country. 

## Hepatitis A Vaccine Coverage (>1 dose) Among 24-35 Month Old Children, National Immunization Survey, United States, Jan-Jun 2003*

- Source: L Barker, NIP. Provisional data, 2003 NIS

**Coverage range among ****11 states: 5-74%**

**Coverage range among****6 states: 0-30%**

**Hepatitis A Vaccine Coverage (>1 dose) Among ****24-35 Month Old Children, National Immunization Survey, United States, Jan-Jun 2003***

**% Received **_**>**_**1 Dose Hepatitis A Vaccine**

**Notes:**
If we want to demonstrate that vaccination is playing a large role in this changing epidemiology of hepatitis A, we need coverage data to show that vaccination programs are being implemented.  For most vaccines, the National Immunization Survey is used to estimate coverage. However, this survey measures coverage among 19-35 month olds, and the hepatitis A vaccine is only licensed for children 24 months and older. Despite this limitation, questions about this vaccine were for the first time, on the 2003 survey. The results, limited to children 24 to 35 months old, are shown here. Overall, 44% living in the 11 states where vaccination is recommended had received 1 or more doses of vaccine, shown in red. Coverage was 26% in this age group in the 6 states where the recommendations is to consider vaccination. As expected coverage is low in states without a recommendation, in gray. The overall US coverage was 15% in this age group. 

## Hepatitis A Incidence, United States, 1980-2002

- Source Wasley, DVH, CDC. Unpublished NNDSS data

**Hepatitis A Incidence, ****United States, 1980-2002**

**Notes:**
So what has happened with hepatitis A incidence?  Here I have indicated the date of vaccine licensure Click and the date when the ACIP click made the statewide vaccination recommendations. As you can see, incidence has been falling; Since 1999 incidence has remained below recorded historic lows. 

## 1987-97 Average Incidence by County

**1987-97 Average ****Incidence by County**

** **_**>**_** 20**

**10 - 19**

**    ****5 - 9**

**    ****0 - 4**

_**Rate per 100,000**_

**2002 Incidence ****by County**

**Notes:**
This decline has been particularly remarkable in areas of the United States that suffered through a high incidence for many years, mainly the Western areas. Here are two county maps of the U.S. - one you have seen before, on the upper left, that shows counties with a consistently high incidence over an 11 year span in red and orange. Now on the lower right, the same color schemes, from the 2002 NNDSS data. You can see that very few counties are red or orange – in fact most counties, even in the West, are now white indicating an incidence <4 per 100,000.

## Incidence of Hepatitis A by Statewide ACIP Recommendation Status, 1966-2002

**Incidence of Hepatitis A by Statewide ****ACIP Recommendation Status, 1966-2002**

**ACIP vaccine **
**recommendations**

**Notes:**
Here you see the incidence of hepatitis A over a long time period, since 1966, in the inset, to show you how consistently elevated rates were, over many years, in areas where vaccination was recommended. The gray area has been enlarged in the bottom graph. As you can see, rates in states where vaccine was recommended in 1999 have declined to about the same as the rate in states where no recommendation was made. States where vaccine was recommended or suggested accounted for approximately 2/3 of cases during that 11 year baseline period. In 2002 these states only accounted for 1/3 of cases. This represents a compelling ecologic correlation between where vaccine was given and where incidence fell most dramatically. Was this due to vaccination? 

## Hepatitis A Incidence by Race/Ethnicity, United States, 1990-2002

**Notes:**
Here is the incidence data once again, this time broken down by race and ethnicity. There was a very dramatic decline among American Indians and Alaskan Natives, who had an incidence so high in the early 1990’s that it cannot be shown on the main graph – you have to look at the inset. American Indians and Alaskan Natives rapidly achieved coverage levels over 50% among children, and the result was that the incidence declined to below that of the other racial and ethnic groups seen here. This has been a remarkable success story that is only now beginning to get out into the literature.
Note that Hispanic children have consistently had rates above those of their children – even now, the rate among Hispanic children is twice that of other children. But Hispanic children in 2003 have an incidence below the overall childhood incidence in 1998.

## ABCs as a Platform for Monitoring New Vaccines

**Source:**
**Elizabeth R. Zell**
**National Center for Infectious Diseases**
**Atlanta, Georgia**

## Active Bacterial Core Surveillance (ABCs)Emerging Infections Program Network

_**Areas**_
**OR (3 counties)**
**CA (1 county)**
**MN (7 counties)**
**GA (20 counties)**
**MD (6 counties)**
**CT (entire state)**
**NY (7 counties)**
**TN (10 counties)**
**CO (8 counties)**
**NM (entire state)**

- Established

- New

## Pneumococcal Conjugate Vaccine Introduction in the U.S.

| Feb 2000 | 7-valent vaccine (PrevnarTM) licensed |
| --- | --- |
| Summer &Fall 2000 | Recommendations for vaccine use
Government purchasing 
Rapid increase in use |
| Aug 2001 – May 2003 | Shortage |
| Feb 2004 | Another shortage! |

|  |
| --- |

## U.S. Recommendations for Use of Pneumococcal Conjugate Vaccine

**All children < 2 years**
**Children 2 - 4 years with chronic illness, immunocompromising conditions**
**Consider for all children 2-4 with ****priority to those**
**24-35 months**
**Alaska Native, American Indian, ****African American**
**Attending day care**

- Advisory Committee on Immunization Practices.  MMWR 2000

## Receipt of PCV7 Among Children 19-35 Months*, U.S, 2002-2003 

- *Children were born between August 1999 & November 2001
-   National Immunization Survey, Q3/2002-Q2/2003

**Number of Doses**

**Receipt of PCV7 Among Children ****19-35 Months*, U.S, 2002-2003 **

## Invasive Pneumococcal Disease Rates by Age and Year Children <5 Years, ABCs, 1998-2003

**<1 yr**

**2 yrs**

**3 yrs**

**4 yrs**

**1 yr**

**- 77% (<1 yr)**

**- 83% (1 yr)**

**- 64% (2 yr)**

_**2003 vs baseline**_

**- 60% (3 yr)**

**- 48% (4 yr)**

- Source:  ABCs (April 2004), Observed Rates
- Sites:  CA (SF co), CT, GA (20 co), MD (6 co), MN (7 co), NY (7 co), OR (3 co)
- 2003 data are preliminary

## Invasive Pneumococcal DiseaseBlack and White Children <5, 1998–2003

**Black**

**White**

- Source:  ABCs (April 2004), Observed Rates
- Sites:  CA (SF co), CT, GA (20 co), MD (6 co), MN (7 co), NY (7 co), OR (3 co)
- Healthy People 2010 target: 46 per 100 000

**Conjugate vaccine **

**2.9 X**

**2.0 X**

- 2003 data are preliminary

## Herd Effect Invasive Disease Rates for Vaccine Serotypes ABCs 1998/99 vs. 2003

| Age group | Cases/100,000 pop |  | % change (95% CI) |
| --- | --- | --- | --- |
|  | Baseline | 2003 |  |
| <2 mo | 30.5* | 14.4 | -53 (-80, +22) |
| 5-17  yrs | 2.5 | 1.2 | -51 (-66, -30) |

- Number of cases =8 in 1998, 14 in 1999 and 6 in 2003
- 2003 data are preliminary

## Invasive Pneumococcal Disease Rates in Adults by Age Group and Year – ABCs, 1998-2003

**65+ years**

**20-39 yrs**

**40-64 yrs**

**- 31%**

**- 20%**

**- 41%**

**2003 ****vs ****baseline**

- Source:  ABCs (April 2002), Observed Rates
- Sites:  CA (SF co), CT, GA (20 co), MD (6 co), MN (7 co), NY (7 co), OR (3 co)

- 2003 data are preliminary

## Challenges- 2004 - 

## Federal Contract Vaccine Prices For Vaccines Recommended Universally for Children, 1985 – 2004*

- Federal contract price shown for one year is an average that accounts for price changes within the year.
- An estimate is provided for 2004 since contract prices may change in August 2004
- As of April 14, 2004

**$45**

**$114**

**$472**

## Public Sector Vaccine Cost to Fully Vaccinate a Child

## Percent Increase of the Cost of Full Series vs. Percent Increase of Appropriation

- Percentage Calculations:  %  increases are cumulative using 1999 as the base year.

## Number of Children Who Could Potentially Receive Full Series with Section 317 Funds

## Pneumococcal Conjugate Vaccine (PCV) Two-Tier Policies, by State, United States*

**Pneumococcal Conjugate Vaccine (PCV) ****Two-Tier Policies, by State, ****United States***

**D.C.**

- *As of February 2003

- If all States implemented PCV and flu, the 2004 funding shortfall would be $55 Million

**States with a two-tiered PCV policy ****(19 states are not implementing PCV with 317 funds)**
**States without a two-tiered PCV policy**

## CustomersPeople Whose Health We Can Improve

**Coordinating Center for Health Information and Services**

**Business**

**Public Health Systems ****and Communities**

**Health Care **
**Delivery**

**Federal****Agencies**

**Education**

**National**
**Center for Health ****Marketing**

**National Center ****for**
**Public Health**
**Informatics**

**National Center for**
**Health Statistics**

**Coordinating Center **
**for Infectious Diseases**
**NCID, NCHSTP, NIP**

**Coordinating ****Center for ****Health Promotion**
**NCCDPHP, NCBDDD, ****Genomics**

**Coordinating ****Center for EIO **
**NCEH/ATSDR**
**NCIPC, NIOSH**

**Office ****of Global Health**

**Office of Terrorism**
**Preparedness & **
**Emergency Response**

**Office of Strategy ****and Innovation**

**Office of the Chief of **
**Science**

**Office of the Chief ****of Public**
**Health Improvement**

**Office of Human Capital ****and Professional ****Development**

**Customers****People Whose Health We Can Improve**

**Executive Leadership Team**

**Management Council**

**Executive Board**

**Partners**

**Alliances**

**Stakeholders**

**Office of the Chief ****Operating Officer**

**Office of the ****Chief of Staff**

**CDC Washington Office**

**Director**

**Channels**

**Notes:**
Surgical adverse events, including surgical site infections, are a public health problem and a patient safety issue. 
Most of them are preventable and their prevention is a public health intervention priority. 

## Health Protection Goals

**Health Promotion & Prevention of Disease, Injury, and Disability: **
**	****All people will achieve their optimal lifespan with the best possible quality of health in every stage of life. **
**Preparedness: **
**	****People in all communities will be protected from infectious, environmental, and terrorist threats.**

**Notes:**
In addition to the six strategic imperatives, we identified two overarching health protection goals.  The first is achieving health promotion and prevention of disease, injury and disability for all people in every stage of life.  The second is preparedness and protection for people everywhere from infectious, environmental and terrorist threats.

While we are goal driven, we recognize that science cannot be completely goal driven.  Science also needs to be creative and innovative.  There must be an entrepreneurial spirit.  We must support scientists as they identify new ideas and take risks.  That is essential to our success and we want to preserve and protect that capability.    

## Blue Ribbon Panel on Vaccine Safety – Objectives

**Review the structure, function, credibility, effectiveness, efficiency, and support of CDC’s vaccine safety program and assess how it can be maximized and sustained.**
**Review the intramural and extramural collaborative activities of the vaccine safety program and determine their effectiveness and efficiency.**

## Blue Ribbon Panel on Vaccine Safety – Objectives

**Determine the optimal organizational location for vaccine safety activities within the CDC to ensure scientific objectivity, transparency, and oversight while at the same time ensuring that program priorities are established appropriately and are relevant to the immunization program and stakeholder needs.**

*(continued)*

## Panel Composition - 1

**Non-government professional**
**organizations:**
**AMA**
**AAP**
**AAFP**
**AAHIP**
**PhRMA**
**Vanderbilt University School of Medicine**

## Panel Composition - 2

**Advocacy groups and/or other**
**professional groups:**
**Autism Society of America**
**Cure Autism Now**
**National Vaccine Information Center**
**Public Citizen’s Health Research Group**

## Panel Composition - 3

**Government Advisory Committees:**
**	****-****	****ACIP****	****	****	****-     ****	****NVAC**
**Government Agencies:**
**   ****-     FAA****	****	****	****-****	****FDA**
**   ****-****	****HHS/NVPO****	****-****	****HRSA**
**	****-****	****NTSB**