VPD: Policy, Practice, Preparedness Conference An inside View of ACIP Vaccine Recommendations Larry K, Pickering, MD, FAAP, FIDSA July 23, 2012 National Center for Immunization & Respiratory Diseases Office of the Director FINANCIAL DISCLOSURE: 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 discussed in this presentation. 2 Objectives 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 societies To highlight the GRADE process now used by ACIP To summarize key issues facing the ACIP 3 1
Diseases Prevented by Vaccination* 1986 (8) 2012 (17) Diphtheria Diphtheria Hepatitis A Tetanus Tetanus Hepatitis B Pertussis Pertussis Human papillomavirus Polio (OPV) Polio (IPV) Influenza Measles Measles Meningococcal disease Mumps Mumps Pneumococcal disease Rubella Rubella Rotavirus Hib disease Hib disease Varicella Zoster * Vaccines in routine immunization schedule in the U.S. 4 Advisory Committee on Immunization Practices Background - Origins and Role ACIP was established in 1964 by the Surgeon General of US Public Health Service ACIP designated by the FACA as a Federal Advisory Committee in 1972 Role: 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 Practices VFC 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 6 2
Advisory Committee on Immunization Practices VFC Program Eligible children (through 18 years of age): Medicaid eligible Uninsured American Indian/Alaska Native Underinsured VFC is a federal entitlement program - current cost is ~$3 billion annually http://www.cdc.gov/vaccines/programs/vfc/default.htm http://www.cdc.gov/vaccines/programs/vfc/providers/acip-whatis.htm 7 ACIP recommended statute; 8 Development of vaccine recommendations and policies 9 3
Structure of the Advisory Committee on Immunization Practices Members 15 Liaison organizations 30 Ex officio Members 8 Reports to CDC Director Meetings per year 3 (Webcast) Vaccine Recommendations All ages http://www.cdc.gov/vaccines/recs/acip/ Ann Intern Med 2009; 150:45-49 10 Advisory Committee on Immunization Practices Structure 15 voting members including chairperson (non-government) - 4 year terms - ACIP steering committee nominates, HHS selects - One consumer representative - Members screened for conflicts of interest 11 Advisory Committee on Immunization Practices Structure 8 ex officio members representing other government agencies that are involved in immunization (non-voting) 30 liaison organizations representatives of professional societies and organizations responsible for vaccine development and immunization programs (non-voting) Behind the scenes: ACIP Work Groups 12 4
CDC Approval Process Following an ACIP Vaccine Recommendation Brief Recommendation Full Recommendation ( ACIP Statement ) Published in MMWR Weekly as a Policy Note within 2 months of an ACIP vote Provisional recommendations are posted on ACIP website within 3 weeks 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 Final recommendations are published in MMWR Recommendations & Reports within 6-8 months of an ACIP vote MMWR 2012: 61(25);468-470 Mmwr article 14 Expertise of ACIP Members Infectious diseases Immunology Virology and bacteriology Pediatrics including adolescent medicine Internal medicine Family medicine Nursing Public health, preventive medicine Vaccine research and policy Consumer concerns Economics, cost-effectiveness GRADE Process 15 5
Liaison Organizations* Members attend and participate in every ACIP meeting Members serve on ACIP work groups Five organizations assist with development and publication of immunization schedules All 30 liaison organizations support ACIP recommendations *non-voting 16 Immunization Policy Recommending Bodies Advisory Committee on Immunization Practices American Academy of Pediatrics Committee on Infectious Diseases American Academy of Family Physicians American College of Physicians American College of Obstetricians and Gynecologists 18 ACIP Work Groups Gather, analyze and prepare information for presentation to ACIP Develop draft policies/options for review/vote by full ACIP Work by teleconference throughout the year, and before/during ACIP meetings 19 6
ACIP 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 including Immunization Safety Office, ex officio members, liaison representatives, invited consultants Task oriented WGs are disbanded when work complete; new WGs formed as required 20 ACIP Work Groups (WG) July 2012 PERMANENT WG TASK ORIENTED WG Adult Immunization General Recommendations Harmonized Schedule Influenza Hepatitis Vaccines Human Papillomavirus Vaccines Meningococcal Vaccines Pertussis-containing Vaccines Pneumococcal Vaccines Herpes Zoster (Shingles) Vaccine Japanese Encephalitis Vaccine MMR Vaccine 21 22 7
23 Advisory Committee on Immunization Practices Process 3 meetings annually February, June, and October. Each meeting is two days Agenda items - Topics solicited from ACIP members, liaisons, CDC staff and others using standard format - Finalized by ACIP Steering Committee Follow FACA* rules and procedures including meetings that are open to the public with time for public comment Meeting slides, live webcast archive, minutes posted on ACIP website Recommendations become final once approved by CDC Director and published in MMWR * Federal Advisory Committee 24 Act Standardization 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/economicstudies.htm Vaccine acronyms and abbreviations http://www.cdc.gov/vaccines/about/terms/vaccabbrev.htm Provisional recommendations www.cdc.gov/vaccines/recs/provisional/default.htm Evidence based recommendations www.cdc.gov/vaccines/recs/acip/grade/tablerefs.htm 25 8
Evidence Based Recommendations 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 recommendations System used: Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework GRADE was implemented for new recommendations beginning in October 2011 - HPV vaccine in males - Hepatitis B vaccine in people with diabetes mellitus 26 http://www.cdc.gov/vaccines/recs/acip/ Institute of Medicine Eight standards for developing rigorous, trustworthy clinical practice guidelines Establishing transparency Management of conflict of interest Guideline development group composition Evidence based on systematic reviews Method for rating strength of recommendations Articulation of recommendations in a standardized form External review Updating Ref: IOM. Clinical Practice Guidelines We Can Trust. March 23, 2011 27 The ACIP Process: Evidence Considered in Immunization Policy Development FDA licensed indications and schedule Disease burden overall and in high risk groups Vaccine efficacy and effectiveness Data on safety in general and specific groups Feasibility in the context of existing recommendations Equity in access to vaccine and good use of public funds (cost effectiveness) Recommendations of other groups (AAP, AAFP, ACP, ACOG) 28 9
ACIP Recommendation Categories Category A recommendations are made for all persons in an age- or risk-factorbased 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. 29 Body of Evidence is Categorized into Four Types (1) Randomized controlled trials (RCTs), or overwhelming evidence from observational studies. (2) RCTs with important limitations, or exceptionally 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 GRADE Full description and answers to frequently asked questions about GRADE http://www.cdc.gov/vaccines/recs/acip/grade/table-refs.htm Video: The GRADE Approach - An Introductory Workshop on Making Recommendations - Video part 1: Overview of the GRADE Approach and the Process Run 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. 31 10
32 GRADE Uptake World Health Organization CDC-ACIP Allergic Rhinitis in Asthma Guidelines (ARIA) American Thoracic Society American College of Physicians European Respiratory Society European Society of Thoracic Surgeons British Medical Journal Infectious 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 GIN Over 60 (major) organizations 33 Immunization Policy Product: Two 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 changed ACIP, AAFP, ACOG and ACP produce a harmonized adult immunization schedule Both schedules are updated annually and are published in February Display the complete schedule, with each vaccine in the context of the other vaccines 34 11
Recommended Immunization Schedules for People in the United States Pediatric and Adolescent 0 through 6 years of age 7 through 18 years of age Catch-up schedule for children - 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 36 37 12
The Fine Print 38 Recent ACIP Recommendations PCV13 use among immunocompromised adults 6/2012 Influenza vaccine recommendations 6/2012 Tdap in people 65 years of age and 2/2012 older HPV4 vaccine in males 10/2011 Child and adult schedules 10/2011 HBV in adults with diabetes mellitus 10/2011 39 40 13
Future Considerations Duration of protection of Tdap Use of PCV13 in adults Use of meningococcal vaccines in infants Use of zoster vaccine in adults beginning at 50 years of age New influenza vaccine preparations Mumps protection Vaccine hesitancy and pseudoscience 41 The End 42 14