acip – developing vaccine recommendations and policy in the...

ACIP – Developing Vaccine Recommendations and Policy in the US

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VPD: Policy, Practice, Preparedness Conference

An inside View of ACIPV i R d ti

Larry K, Pickering, MD, FAAP, FIDSAJuly 23, 2012

National Center for Immunization & Respiratory DiseasesOffice of the Director

Vaccine Recommendations

FINANCIAL DISCLOSURE:FINANCIAL DISCLOSURE:Larry K. Pickering, M.D., F.A.A.P.Larry K. Pickering, M.D., F.A.A.P.

In the past 12 months, I have not had a financial interest or other relationship with manufacturer(s) of product(s) or provider(s) of service(s) that will be p ( ) ( )discussed in this presentation.

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ObjectivesObjectives

To discuss responsibilities, structure, and function of the ACIP To review the process of immunization policy development in the U.S.To summarize interactions with professional organization and societiesTo highlight the GRADE process now used by ACIPTo summarize key issues facing the ACIP

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Diseases Prevented by Diseases Prevented by Vaccination*Vaccination*

1986 (8) 2012 (17)Diphtheria Diphtheria Hepatitis ATetanus Tetanus Hepatitis BPertussis Pertussis Human papillomavirusPertussis Pertussis Human papillomavirusPolio (OPV) Polio (IPV) InfluenzaMeasles Measles Meningococcal diseaseMumps Mumps Pneumococcal diseaseRubella Rubella RotavirusHib disease Hib disease Varicella

Zoster

* Vaccines in routine immunization schedule in the U.S. 4

Advisory Committee on Immunization PracticesAdvisory Committee on Immunization PracticesBackground Background -- Origins and RoleOrigins and Role

ACIP was established in 1964 by the Surgeon General of US Public Health ServiceACIP designated by the FACA as a Federal Advisory Committee in 1972Role: provide advice and guidance to the CDCRole: provide advice and guidance to the CDC Director, and the Secretary of HHS on most effective means to prevent vaccine-preventable diseases in the civilian population in the U.S.- Vaccines and related agents* - FDA-licensed vaccines (and unlicensed

vaccines if warranted) * antisera, IG, antiviral agents 5

Advisory Committee on Immunization PracticesAdvisory Committee on Immunization PracticesVFC ProgramVFC Program

Vaccines for Children (VFC) Program –established in August 1993, operational since October 1994- Unique statutory authority gives ACIP authority to determine vaccines provided in the VFC Program

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Advisory Committee on Immunization PracticesAdvisory Committee on Immunization PracticesVFC ProgramVFC Program

Eligible children (through 18 years of age):• Medicaid eligible• Uninsured• American Indian/Alaska Native

VFC is a federal entitlement program - current cost is ~$3 billion annually

http://www.cdc.gov/vaccines/programs/vfc/default.htmhttp://www.cdc.gov/vaccines/programs/vfc/providers/acip-whatis.htm

• American Indian/Alaska Native• Underinsured

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ACIP recommendedstatute;

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Development of vaccine recommendations and policies

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Structure of the Structure of the Advisory Committee on Immunization PracticesAdvisory Committee on Immunization Practices

Members 15Liaison organizations 30Ex officio Members 8

http://www.cdc.gov/vaccines/recs/acip/Ann Intern Med 2009; 150:45-49

Ex officio Members 8Reports to CDC DirectorMeetings per year 3 (Webcast)Vaccine Recommendations All ages

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Advisory Committee on Immunization PracticesAdvisory Committee on Immunization PracticesStructureStructure

15 voting members including chairperson (non-government)- 4 year terms- ACIP steering committee nominates- ACIP steering committee nominates, HHS selects

- One consumer representative- Members screened for conflicts of interest

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Advisory Committee on Immunization PracticesAdvisory Committee on Immunization PracticesStructureStructure

8 ex officio members – representing other government agencies that are involved in immunization (non-voting)30 liaison organizations – representatives30 liaison organizations – representatives of professional societies and organizations responsible for vaccine development and immunization programs (non-voting)Behind the scenes: ACIP Work Groups

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CDC Approval Process Following an ACIP Vaccine Recommendation

Full Recommendation (“ACIP Statement”)Brief Recommendation

Provisionalrecommendations are posted on

ACIP website within 3 weeks of an ACIP vote

Final recommendations are published in MMWR

Recommendations & Reportswithin 6-8 months of an ACIP vote

Published in MMWR Weeklyas a Policy Note within 2 months of an ACIP vote

*All ACIP recommendations are not final until approved by the CDC director and published in MMWR.www.cdc.gov/vaccines/recs/acip

Mmwr article

MMWR 2012: 61(25);468-470

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Expertise of ACIP MembersExpertise of ACIP Members

Infectious diseasesImmunologyVirology and bacteriologyPediatrics including adolescent medicineInternal medicineFamily medicineFamily medicineNursingPublic health, preventive medicineVaccine research and policyConsumer concernsEconomics, cost-effectivenessGRADE Process

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Liaison Organizations*Liaison Organizations*

Members attend and participate in every ACIP meetingMembers serve on ACIP work groupsFive organizations assist withFive organizations assist with development and publication of immunization schedulesAll 30 liaison organizations support ACIP recommendations

*non-voting 16

Immunization Policy Recommending Bodies

Advisory Committee on Immunization Practices

American Academy of Pediatrics C itt I f ti DiCommittee on Infectious Diseases

American Academy of Family Physicians

American College of Physicians

American College of Obstetricians and Gynecologists 18

ACIP Work GroupsACIP Work Groups

Gather, analyze and prepare information for presentation to ACIPDevelop draft policies/options for review/vote by full ACIPWork by teleconference throughout the year, and before/during ACIP meetings

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ACIP Work GroupsACIP Work Groups

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

Other members: lead CDC staff, other CDC staff includingother CDC staff including Immunization Safety Office, ex officio members, liaison representatives, invited consultants

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

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ACIP Work Groups (WG) – July 2012

PERMANENT WG• Adult Immunization• General Recommendations• Harmonized Schedule• Influenza

• Hepatitis Vaccines• Human Papillomavirus Vaccines

TASK ORIENTEDWG

• Human Papillomavirus Vaccines• Meningococcal Vaccines• Pertussis-containing Vaccines• Pneumococcal Vaccines• Herpes Zoster (Shingles) Vaccine• Japanese Encephalitis Vaccine• MMR Vaccine

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Advisory Committee on Immunization PracticesAdvisory Committee on Immunization PracticesProcessProcess

3 meetings annually – February, June, and October. Each meeting is two daysAgenda items

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

- Finalized by ACIP Steering Committeey gFollow FACA* rules and procedures including meetings that are open to the public with time for public commentMeeting slides, live webcast archive, minutes posted on ACIP websiteRecommendations become final once approved by CDC Director and published in MMWR

* Federal Advisory Committee Act24

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

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

Evidence based recommendations –www.cdc.gov/vaccines/recs/acip/GRADE/table-refs.htm

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Evidence Based Evidence Based RecommendationsRecommendations

In October 2010 ACIP voted unanimously to adopt a methodology to assist in development of clear and uniform evidence assessment and reporting for future ACIP recommendationsSystem used: Grading of Recommendations, A t D l t d E l tiAssessment, Development and Evaluation (GRADE) frameworkGRADE was implemented for new recommendations beginning in October 2011- HPV vaccine in males- Hepatitis B vaccine in people with diabetes

mellitushttp://www.cdc.gov/vaccines/recs/acip/

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Institute of MedicineInstitute of MedicineEight standards for developing rigorous, trustworthy clinical practice guidelines• Establishing transparency• Management of conflict of interest• Guideline development group composition• Evidence based on systematic reviews

M h d f i h f d i• Method for rating strength of recommendations• Articulation of recommendations in a standardized

form• External review• Updating

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Ref: IOM. Clinical Practice Guidelines We Can Trust. March 23, 2011

The ACIP Process: Evidence Considered The ACIP Process: Evidence Considered in Immunization Policy Developmentin Immunization Policy Development

FDA licensed indications and scheduleDisease burden overall and in high risk groupsVaccine efficacy and effectivenessD t f t i l d ifiData on safety in general and specific groupsFeasibility in the context of existing recommendationsEquity in access to vaccine and good use of public funds (cost effectiveness)Recommendations of other groups (AAP, AAFP, ACP, ACOG) 28


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ACIP Recommendation CategoriesACIP Recommendation Categories

Category A recommendations are made for all persons in an age- or risk-factor-based group.

Category B recommendations are made for individual clinical decision making.

Evidence tables are used to summarize benefits and harms and strengths and limitations of the body of evidence.

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Body of Evidence is Categorized Body of Evidence is Categorized into Four Typesinto Four Types

(1) Randomized controlled trials (RCTs), or overwhelming evidence from observational studies.

(2) RCTs with important limitations, or ti ll t id fexceptionally strong evidence from

observational studies (OS).(3) RCTs with notable limitations or OS.(4) RCTs with several major limitations, OS

with important limitations or clinical experience and observations.

Vaccine 2011; 29:9171-76 30

CDC Resources for Learning More About CDC Resources for Learning More About GRADEGRADE

Full description and answers to frequently asked questions about GRADE http://www.cdc.gov/vaccines/recs/acip/GRADE/table-refs.htmVideo: The GRADE Approach - An Introductory Workshop on Making Recommendations

- Video part 1: Overview of the GRADE Approach and the Processp ppRun time: 88:07

- Video part 2: Assessing the Quality of Evidence Run time: 100:62

Slide presentations: - New Framework for Developing Evidence-Based Recommendations

by the ACIP

Publication: - Ahmed F et al. Methods for developing evidence-based

recommendations by the ACIP – Vaccine 2011;29(49):9171-9176.

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GRADE UptakeGRADE UptakeWorld Health OrganizationCDC-ACIPAllergic Rhinitis in Asthma Guidelines (ARIA) American Thoracic Society American College of PhysiciansEuropean Respiratory SocietyEuropean Society of Thoracic SurgeonsBritish Medical JournalInfectious Disease Society of America American College of Chest Physicians UpToDate® National Institutes of Health and Clinical Excellence (NICE)Scottish Intercollegiate Guideline Network (SIGN)Cochrane Collaboration Clinical Evidence Agency for Health Care Research and Quality (AHRQ)Partner of GINOver 60 (major) organizations

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Immunization Policy Product: Immunization Policy Product: Two Immunization SchedulesTwo Immunization Schedules

ACIP, AAP, and AAFP produce a “harmonized” childhood and adolescent immunization schedule- First harmonized in 1994- Before 1994, differing schedules existed- In 2007 format of childhood and adolescent schedule

changedchangedACIP, AAFP, ACOG and ACP produce a harmonized adult immunization scheduleBoth schedules are updated annually and are published in FebruaryDisplay the complete schedule, with each vaccine in the context of the other vaccines

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Recommended Immunization Schedules Recommended Immunization Schedules for People in the United Statesfor People in the United States

Pediatric and Adolescent• 0 through 6 years of age• 7 through 18 years of age• Catch-up schedule for childrenp

- 4 months through 6 years of age- 7 through 18 years of age

Adult• Age ranges• Medical and other indications

http://www.cdc.gov/vaccines/recs/schedules/default.htm 35

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The Fine PrintThe Fine Print

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Recent ACIP RecommendationsRecent ACIP Recommendations

PCV13 use among immunocompromised adults

6/2012

Influenza vaccine recommendations 6/2012

Tdap in people 65 years of age and 2/2012Tdap in people 65 years of age and older

2/2012

HPV4 vaccine in males 10/2011

Child and adult schedules 10/2011

HBV in adults with diabetes mellitus 10/201139

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Future ConsiderationsFuture Considerations

Duration of protection of TdapUse of PCV13 in adultsUse of meningococcal vaccines in infantsUse of zoster vaccine in adults beginningUse of zoster vaccine in adults beginning at 50 years of ageNew influenza vaccine preparationsMumps protectionVaccine hesitancy and pseudoscience

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The End

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