global vaccines 202x: access, equity, ethics 2-4 may 2011 the franklin institute science museum

CVEP Symposium:

Global Vaccines 202X: Access, Equity, Ethics2-4 May 2011

The Franklin Institute Science Museum. Philadelphia, USA


The Franklin Institute Science MuseumPhiladelphia, USA

Advisory Committee on Immunization Practices (ACIP) to the Center for Disease Control and Prevention

Carol J. Baker, M.D., ACIP Chair

Professor Pediatrics, Molecular Virology and Microbiology, Baylor College of Medicine

Houston, TX

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BackgroundBackground

Established in 1964 Role: to provide advice and guidance to the CDC Director and

the Office of the Secretary of the Department of Health and Human Services on the most effective means to prevent vaccine-preventable diseases

Vaccines and related agents– (e.g., antisera, immune globulins, antiviral agents)

– FDA-licensed vaccines Federal Advisory Committee Act (FACA) 1972

– Mechanism to seek advice and recommendations of U.S. citizens in Federal Government’s decision- making process

– Provide relevant and objective advice

– Meetings open to the public; all committee documents available for public inspection; public comment each meeting

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StructureStructure

15 voting members: (non-government)– 4 year terms

– ACIP steering committee nominates, Secretary of DHHS selects

– One consumer representative

– Members screened for conflicts of interest

8 ex officio members: representing government agencies involved in immunization (non-voting)

30 liaison members: representatives of professional societies and organizations responsible for vaccine development & immunization programs (non-voting)

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Conflicts of Interest

Extensive financial disclosures before appointment as a member of ACIP with annual updating

Before each ACIP meeting, each voting member must disclose COI’s

Those with COI’s may not discuss or vote on vaccines related to manufacturer(s) of the recommendation being voted upon

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Expertise of ACIP MembersExpertise of ACIP Members

Infectious diseases

Immunology

Virology and bacteriology

Pediatrics including adolescent medicine

Internal and family medicine

Nursing

Public health, preventive medicine

Vaccine research and policy

Consumer concerns

Health economics, cost-effectiveness

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ACIP Support from the Centers for ACIP Support from the Centers for Disease Control and PreventionDisease Control and Prevention

Lead staff for each work group Subject matter experts for each work group Vaccine safety expertise Health Economic analysis expertise Evidence-based medicine expertise Funding

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ACIP Work Groups (WG)ACIP Work Groups (WG)

Gather, analyze and prepare information

Develop draft policies / options for review / vote by full ACIP

Work by teleconference throughout the year

WG is chaired by an ACIP member and must include at least 1 other ACIP member

Other members: lead CDC staff, other CDC staff including Immunization Safety Office, ex officio representatives, liaison members, AIM member and consultants

Task oriented WGs are disbanded when work complete; new WGs formed as required

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ACIP Work Groups (WG) - December 2010

PERMANENT WG

1 Adult Immunization2 General Recommendations3 Harmonized Schedule4 Influenza Vaccines

TASK ORIENTED WG

5 Evidenced Based Recommendations6 Hepatitis Vaccines7 Human Papillomavirus Vaccines8 Meningococcal Vaccines9 Pertussis Vaccines

10 Pneumococcal Vaccines11 Herpes-zoster (singles) Vaccine12 Rotavirus Vaccines13 Japanese Vaccines

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What is Considered in Decisions

Disease burden

Surveillance and epidemiology

Vaccine efficacy

Safety

Cost-effectiveness

Program impact

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Transparency

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ACIP:ACIP: ProcessProcess

3 2-day meetings annually: Feb., June, and Oct. Agenda items

– Topics solicited from ACIP members, liaisons, CDC staff and others using a standard format

– Finalized by ACIP Steering Committee

Follow FACA* rules and procedures: open to the public with time for public comment

Meeting slides and minutes: posted on website Recommendations: final once approved by CDC

Director and published in MMWR* Federal Advisory Committee Act

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Standardization of ACIP ProcessStandardization of ACIP Process

Guidance for pregnant and breastfeeding women – www.cdc.gov/vaccines/recs/ACIP/rec-vac-preg.htm

Economic analysis guidance - www.cdc.gov/vaccines/recs/ACIP/economic-studies.htm

Vaccine acronyms and abbreviations – http://www.cdc.gov/vaccines/about/terms/vacc-abbrev.htm

Evidence based medicine – (approved in October 2010)

Provisional recommendations – www.cdc.gov/vaccines/recs/provisional/default.htm

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http://www.cdc.gov/vaccines/recs/ACIP/economic-studies.htm

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Evidence-Based Evidence-Based RecommendationsRecommendations

Modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology approved by ACIP in October 2010

Clear separation between evidence grade and strength of recommendation

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ACIP Web Site

www.cdc.gov/vaccines/recs/acip

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Immunization Policy Recommending Bodies

ACIP

American Academy of Pediatrics Committee on Infectious Diseases

American Academy of Family Physicians

American College of Physicians

American College of Obstetricians and Gynecologists

http://www.healthjockey.com/images/acp-logo.jpg

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CDC Approval Process Following ACIP Vaccine Recommendation

An update is published in MMWR Weekly as a Policy Note within 2

months of an ACIP vote

Brief RecommendationBrief Recommendation

Final recommendations are published in MMWR

Recommendations & Reports within 6-8 months of an ACIP vote

*all provisional recommendations, final recommendations, and updates are posted on ACIP website: www.cdc.gov/vaccines/recs/acip

Full Recommendation (“ACIP Statement”)

Full Recommendation (“ACIP Statement”)

Provisionalrecommendations are posted on ACIP website within 3 weeks of

an ACIP vote

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U.S. Government Role in Purchasing U.S. Government Role in Purchasing Childhood VaccinesChildhood Vaccines

Vaccines for Children program (VFC)– Entitlement to certain vulnerable children through

18 years of age– 45% of young children eligible for VFC– Mandatory funding– Inclusion of vaccines in VFC is determined by the

ACIP

Section 317 vaccine funding– Discretionary– No restrictions on vaccine or population

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Section 317 Program

7%

Vaccines for Children Program

(VFC)43%State

Purchases3%

Other including Private Sector

47%

Pediatric Vaccines Recommended for Children Pediatric Vaccines Recommended for Children 0 through 6 Years of Age Doses Distributed by Funding 0 through 6 Years of Age Doses Distributed by Funding

Source Calendar Year 2007Source Calendar Year 2007

Source: Biologics Surveillance Data 2007. Represents a national summary of self-reported distribution data by the vaccine manufacturers. The data are an estimate of the annual national distribution and does not equal administration. Reported data may be incomplete and include

possible over-reporting or under-reporting of distribution data and may not reflect all vaccines or manufacturers.“Other” represents all purchases not on CDC contracts, including private, health insurance, and government purchases through other

mechanisms. Data do not include influenza vaccine doses.

Updated July 17, 2008

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ConclusionsConclusions Routine immunizations provide a great benefit

to infants, children, adolescents, and adults and to society

Immunization is a shared public / private responsibility

The ACIP is a well-functioning, well-respected FACA committee

Many challenges face ACIP and implementation of immunization programs in the U.S. including– financing– supply– acceptance

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Thank You!

global vaccines 202x: access, equity, ethics 2-4 may 2011 the franklin institute science museum

Documents

member of acip

acip memberother members

immunization practices

acip meeting

acip chairprofessor

voting member

immunization safety

usaadvisory committee