Update ofThe National Vaccine Plan

Bruce G. Gellin, M.D., M.P.H., and Raymond A. Strikas, MD

National Vaccine Program Office

Department of Health and Human Services

Presentation Outline• Statutory basis for the National Vaccine Program Office and

National Vaccine Plan

• Review of the National Vaccine Plan and areas for revision– Goals and objectives– Priorities

• Vision for a revised National Vaccine Plan

• Evolution of Immunization Issues since 1994

• Scope of the revision

• Process for revision

Statutory Basis for the National Vaccine Program*

• Title XXI Public Health Service Act (P.L. 99-660, Section 2102): National Vaccine Program Director [the Assistant Secretary of Health] shall coordinate and provide direction for

– Vaccine research– Vaccine development– Safety and efficacy testing of vaccines– Licensing of vaccine manufacturers and vaccines– Production and procurement of vaccines– Distribution and use of vaccines– Evaluating the need for and the effectiveness and adverse

effects of vaccines – Governmental and non-governmental activities– Funding of federal activities

*The National Vaccine Program Office monitors, coordinates, and provides leadership for the overall collaborative effort that is the Program.

Statutory Basis for the National Vaccine Program Office - 2

• Title XXI Public Health Service Act (P.L. 99-660, Section 2103):

– NVP Director shall prepare and issue a plan for the implementation of the responsibilities of the Director under section 2102.

– The plan shall establish priorities in [list in sec. 2102] and describe an optimal use of resources to carry out such priorities, and describe how each of the various departments and agencies will carry out their functions in consultation and coordination with

the Program and in conformity with such priorities.

1994 National Vaccine Plan Goals*

1. Develop new and improved vaccines

2. Ensure the optimal safety and effectiveness of vaccines and immunization

3. Better educate the public and members of the health professions on the benefits and risks of immunization

4. Achieve better use of existing vaccines to prevent disease, disability, and death

*Tab 7 in meeting notebook: Goals and Objectives

1994 National Vaccine Plan Priorities

• Childhood Immunization Initiative:

– Improving quality, quantity of vaccination delivery services

– Increasing community participation, education, partnerships

– Reducing vaccine cost

– Improving monitoring of disease and vaccination coverage

– Improving vaccines and vaccine use

1994 National Vaccine Plan Priorities - 2

• Vaccine Development– HIV vaccines– CDC Emerging Infections Plan– NIAID Blue Ribbon Panel

• Improve pertussis, measles vaccines• Combined vaccines• STD vaccines• Respiratory, enteric vaccines• New approaches for vaccine delivery• Vaccine safety

• Policy and Program Development– Pandemic Plan update– Address unmet needs

National Vaccine Plan Status

• Completed in 1994

• Reviewed at NVPO retreat – 1997– NVPO, agencies’ activities related to each Goal, Objective and

Strategy catalogued, reviewed

• No other formal evaluation performed– Evaluation may be difficult, given broad sweep of the Plan’s

Goals and Objectives. – Virtually all vaccine-related activities fit in it

• No revisions since publication

Vision for National Vaccine Plan Update

• 1/19/07: Charge from the Assistant Secretary for Health that the plan be updated “to reflect current priorities and potential future directions … will provide valuable input to me and to HHS in our consideration of forthcoming budget initiatives.”

• “The updated Plan should summarize current priorities for vaccine- and immunization-related research, development and use; contribute to efforts to prioritize the use of existing resources; and identify needs for new resources.”

• Complete the new Plan in early 2008 “so it can be used during deliberations of FY 2009 budget initiatives.”

Evolution of Immunization Issues since 1994

• Disease incidence changes

• New vaccines

• New schedules for children and adults

• Changes in vaccine coverage

• Implementation of immunization information systems (registries)

• Adolescent immunization focus

• Impact of bio-defense and pandemic preparedness activities

Comparison of 20th Century Annual Morbidity and Current Morbidity: Vaccine-Preventable Diseases

Disease20th Century

Annual Morbidity† (1994) 2005††

Percent Decrease to 2005

Smallpox 48,164 (0) 0 100%

Diphtheria 175,885 (2) 0 100%

Measles 503,282 (895) 66 > 99%

Mumps 152,209 (1322) 314 > 99%

Pertussis 147,271 (3290) 25,616 83%

Polio (paralytic) 16,316 (9*) 1* > 99%

Rubella 47,745 (209) 11 > 99%

Congenital Rubella Syndrome 823 (7) 1 > 99%

Tetanus 1,314 (29) 27 98%

Haemophilus influenzae 20,000 (329) 226** 99% †Source: CDC. MMWR April 2, 1999. 48: 242-264

† †Source: CDC. MMWR. August 18, 2006 / 55(32);880-893 *Vaccine-associated paralytic polio (VAPP)** Type b and unknown (< 5 years of age)

Numbers in yellow indicate at or near record lows in 2005

Disease

Pre-Vaccine Era Estimated Annual

Morbidity †

(1994) 2005 EstimatedMorbidity † Percent

Decrease

Hepatitis A 117,333(115,000)

19,18384%

Hepatitis B (acute) 66,232(35,000)

15,35277%

Pneumococcus (invasive)

all ages 63,067 (2) 40,325 36%

< 5 years of age 16,069 (2) 4,400 73%

Varicella 4,085,120 (2) 817,024 80%

Comparison of Pre-Vaccine Era Estimated Annual Morbidity and Current Estimated Morbidity: Vaccine-

Preventable Diseases

† Unpublished CDC data, reported November 20062 as fpr pre-vaccine era

New Vaccine Indications since 1994*

• 1994 – typhoid Vi polysaccharide– Hib/CRM 197 conjugate– plague

• 1995 – varicella• 1996 - hepatitis A• 1998

– rhesus rotavirus– lyme disease

• 2000 – pneumococcal conjugate • 2003 – live attenuated influenza • 2005

– meningococcal conjugate – TdaP for adolescents and adults

• 2006– bovine rotavirus – zoster – human papillomavirus

*not all new vaccines licensed are represented

General Recommendations on Immunization, 1994

Recommended Adult Immunization Schedule, 2007,by Medical or Occupational Indication

Vaccine-Specific Coverage Rates Among Pre-school Aged Children

1967 to 2005

0

20

40

60

80

100

1967 1971 1975 1979 1983 1987 1991 1995 1999 2003

DTP(3+)†

MMR(1+)

Hib (3+) Varicella (1+)

† DTP(3+) is not a Healthy People 2010 objective. DTP(4) is used to assess Healthy People 2010 objectives.

Note: Children in the USIS and NHIS were 24-35 months of age. Children in the NIS were 19-35 months of age.

Source: USIS (1967-1985), NHIS (1991-1993) CDC, NCHS, and NIS (1994-December 2003), CDC, NIP and NCHS; No data from 1986-1990 due to cancellation of USIS because of budget reductions

2010 Target

Percent

Hep B (3+)

Polio (3+)PCV7 (3)+

Receipt of influenza vaccination during the previous 12 months by race/ethnicity among persons >65, 1989-2005, National Health

Interview Survey

0

10

20

30

40

50

60

70

80

90

100

1989

1991

1993

1995

1997

1999

2001

2003

2005

Per

cen

t V

acci

nat

ed

WhiteBlackHispanicHP 2010 goal

Healthy People 2010 Goal

Survey Year

0

10

20

30

40

50

60

70

80

90

100

1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

Perc

ent V

acci

nate

d

White (HR) Hispanic (HR)

Black (HR) 18-64 (not HR)

Healthy People 2010

Percentage of persons aged 18 – 64 years who reported receiving influenza vaccination during the preceding 12 months, by race/ethnicity and survey year – National Health Interview Survey, United States, 1989 – 2005

Immunization Information Systems(Registries)

• Outgrowth of 1993 Childhood Immunization Initiative

• NVAC initiative 1997 and reports in 1999, 2001, and 2007

• As of 12/31/05– 56% of children <6 yrs are participating in an IIS– 75% of public providers participating– 44% of private providers participating– Only one state had not worked to develop an IIS

Adolescent Immunization

• “Hot button” issues*:

– School and non-traditional venue vaccination

– School mandates/laws

– Informed consent

*G. Freed, NVAC, 6/6/06

Biodefense and Pandemic Preparedness

• Project BioShield: – a secure funding source for the purchase of critical medical

countermeasures, such as vaccines, therapeutics, and diagnostics;

– authorizes $5.6 billion over 10 years (not all for infectious disease threats, but includes anthrax, botulism, smallpox)

• Pandemic Preparedness: – 2004: $43 M to assure egg supply– 2004-05: $264 M for clade 1 influenza A/H5N1 vaccine– 2006: $1.2 B for cell-based vaccines,

antigen-sparing approaches– 2007 on: $ TBD for next generation vaccines,

new cell-based facilities, and retrofitting facilities

Other Continuing Challenges• Vaccine safety

• Vaccine financing

• International vaccine issues

• Vaccine Supply

• Achieving Adult Immunization Goals

• Influenza

Scope of National Vaccine Plan Revision

• Federal plan (comprehensive within the federal government)

• Address priorities for 2008-2010

• Include timelines and metrics, where feasible

• Begin with current priorities to develop goals and objectives

• Link to Healthy People 2010

Purposes of a Plan to Consider

• Define our path, or a roadmap

• Identify needs for resources

• Demonstrate that we have an important job, foster teambuilding

• Communicate to others what we do

Revision Process

• HHS interagency task force (at some point include non-HHS agencies: e.g., DoD, VA, USAID)

• Get agencies’ priorities for 2007-2010

• Assess whether to evaluate impact of 1994 plan, and how

• NVAC to review, comment

• Other stakeholders (how to engage?)

• Public engagement?