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Department of Health and Human Services Centers for Disease Control and Prevention DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR DISEASE CONTROL AND PREVENTION Advisory Committee on Immunization Practices (ACIP) Summary Report June 23-24, 2010 Atlanta, Georgia Advisory Committee on Immunization Practices (ACIP) Summary Report June 23-24, 2010 Table of Contents Page Agenda 4-5 Acronyms 6-8 Wednesday, June 23 Welcome and Introductions 9-14 Evidence-Based Recommendations Work Group Introduction: ACIP Implementation of an Explicit Evidence-Based Recommendations Format Professional Organization Perspectives on Development and Endorsement of Recommendations 14-45 GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) WHO’s Strategic Advisory Group of Experts (SAGE): Approach to Evidence-Based Framework Based on GRADE Meningococcal Vaccine Introduction Guillain-Barre Syndrome (GBS) After Receipt of Menactra 46-73 Update on Monitoring of GBS after Receipt of Meningococcal Conjugate Vaccines Meningococcal Conjugate Vaccines and BGS Update on Meningococcal Vaccination Programs Human Papillomavirus (HPV) Vaccines 73-75 HPV Vaccine Update Hepatitis Vaccines Update on Hepatitis Vaccines Work Group Trends in Acute Hepatitis B Virus (HBV) Disease 75-100 Hepatitis B Risk Among Persons With and Without Diabetes Mellitus Hepatitis B Vaccine Safety and Seroprotection Rates Among Persons with Diabetes Mellitus Preview of Proposed Recommendations; Request for Additional Information Pertussis Vaccines Update on Pertussis Vaccines Work Group Activities 100-109 Update on the Pertussis Vaccine Program 13-Valent Pneumococcal Conjugate Vaccine (PCV13) PCV13 VFC Correction 110 Vaccine Supply 111 Public Comments Day 1 112 2 Advisory Committee on Immunization Practices (ACIP) Summary Report June 23-24, 2010 Thursday, June 24 Agency Updates CDC Center for Medicare and Medicaid Services (CMS) Food and Drug Administration (FDA) Department of Defense (DoD) 112-115 Department of Veteran’s Affairs (DVA) Heath Resources and Services Administration (HRSA) Indian Health Services (I HS) National Vaccine Advisory Committee (NVAC) National Vaccine Program Office (NVPO) Influenza Vaccines Introduction 116-148 Influenza Season Update and Summary Influenza Vaccine Effectiveness Influenza Vaccine Work Group Update: Seasonal Doses for Children <9 Receiving No Prior 2009 H1N1 Monovalent 2009 Pandemic H1N1 Monovalent Vaccine Safety Studies Respiratory Syncytial Virus (RSV) Immunoprophylaxis Introduction Epidemiology of RSV Infections 149-157 History of RSV Immunoprophylaxis Summary Healthcare Reform 158-164 Implications for National Immunization Policy and Practice Rotavirus Vaccines 164-177 Update on Porcine Cirocovirus in Rotavirus Vaccines Public Comment Day 2 177-180 Certification 181 Participant Roster 182-188 3 Advisory Committee on Immunization Practices (ACIP) Summary Report June 23-24, 2010 MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) Centers for Disease Control and Prevention 1600 Clifton Road, NE, Tom Harkin Global Communications Center (Building 19), Atlanta, Georgia June 23-24, 2010 AGENDA ITEM PURPOSE PRESIDER/PRESENTER(s) Wednesday, June 23, 2010 8:00 Welcome & Introductions Dr. Carol Baker (Chair, ACIP) Dr. Larry Pickering (Executive Secretary, ACIP; CDC) 8:30 Evidence Based Recommendations Introduction: ACIP implementation of an explicit Information Dr. Jonathan Temte evidence-based recommendation format (ACIP, WG Chair) Professional organization perspectives on & AAFP: Dr. Doug Campos-Outcalt development and endorsement of recommendations AAP: Dr. Joseph Bocchini Discussion ACP: Dr. Gregory Poland GRADE (Grading of Recommendations, Assessment, Dr. Holger Schünemann Development and Evaluation) Information (McMaster University, Canada) WHO’s Strategic Advisory Group of Experts (SAGE): & Dr. Arthur Reingold (UC Berkeley approach to evidence-based recommendations Discussion SPH, SAGE Member) Pilot of explicit evidence-based framework based on Dr. Faruque Ahmed (CDC/NCIRD) GRADE 10 :45 Break 11:15 Meningococcal Vaccine Introduction Information Dr. Cody Meissner (ACIP, WG Chair) Guillain-Barré Syndrome (GBS) after receipt of Dr. Priscilla Velentgas Menactra & (Harvard Pilgrim) Update on monitoring of GBS after receipt of Mr. Eric Weintraub (CDC/NCEZID) meningococcal conjugate vaccines Discussion Meningococcal conjugate vaccines and GBS Vote Dr. Amanda Cohn (CDC/NCIRD) Update on meningococcal vaccination program Dr. Amanda Cohn (CDC/NCIRD) 12:30 Lunch 1:30 Human Papillomavirus (HPV) Vaccines HPV vaccine update Information Dr. Lauri Markowitz & (CDC/NCHHSTP) Discussion 1:45 Hepatitis Vaccines Update on Hepatitis Vaccines Work Group Information Dr. Mark Sawyer (ACIP, WG Chair) Trends in acute hepatitis B virus (HBV) disease Dr. Ruth Jiles (CDC/NCHHSTP) Hepatitis B risk among persons with and without & Dr. Dale Hu (CDC/NCHHSTP) diabetes mellitus Hepatitis B vaccine safety and seroprotection rates Discussion Dr. Philip Spradling (CDC/NCHHSTP) among persons with diabetes mellitus Preview of proposed recommendations; request for Dr. Trudy Murphy (CDC/NCHHSTP) additional information 4 Advisory Committee on Immunization Practices (ACIP) Summary Report June 23-24, 2010 3:30 Break 3:45 Pertussis Vaccines Update on Pertussis Vaccines Work Group activities Information Dr. Mark Sawyer (ACIP, WG Chair) Update on the Pertussis Vaccine Program & Dr. Jennifer Liang (CDC/NCIRD) Discussion 4:30 13-Valent Pneumococcal Conjugate Vaccine (PCV13) PCV13 VFC correction VFC vote Dr. Lance Rodewald (CDC/ NCIRD) 4:45 Vaccine Supply Update on vaccine supply Information Dr. Lance Rodewald (CDC/ NCIRD) Discussion 5:00 Public Comment 5:15 Adjourn Thursday, June 24, 2010 8:0 0 Agency Updates (CDC, CMS, DOD, DVA, FDA, HRSA, IHS, Informatio n ACIP Ex Officio Members NIH, NVAC, NVPO) 8:15 Influenza Vaccines Introduction Information Dr. Kathy Neuzil (ACIP, WG Chair) Influenza season update and summary & Dr. Tony Fiore (CDC/NCIRD) Influenza vaccine effectiveness Discussion Dr. David Shay (CDC/NCIRD) Influenza Vaccine Work Group update Dr. Anthony Fiore (CDC/NCIRD) Vote on number of doses of seasonal vaccine Information required for children age <9 years who received Discussion no prior 2009 H1N1 monovalent vaccine Vote VFC vote VFC Vote Dr. Lance Rodewald (CDC/NCIRD) 2009 pandemic H1N1 monovalent vaccine safety Information Dr. Frank DeStefano (ISO/NCEZID) studies & Dr. Tracy Lieu (Harvard Pilgrim) Discussion Dr. Hector Izurieta (CBER/FDA) 10:45 Break 11:00 Respiratory Syncytial Virus (RSV) Immunoprophylaxis Introduction Information Dr. Lance Chilton (ACIP, WG Chair) Epidemiology of RSV infections Information Dr. Gayle Fischer Langley & (CDC/NCIRD) History of RSV immunoprophylaxis Discussion Dr. Cody Meissner (ACIP Member) Summary Dr. Lance Chilton (ACIP, WG Chair) 12:15 Lunch 1:15 Health Care Reform and its Implications for National Information Attorney Sara Rosenbaum Immunization Policy and Practice (ACIP Member) 1:45 Rotavirus Vaccines Update on porcine circovirus in rotavirus vaccines Information Dr. Umesh Parashar (CDC/NCIRD) Dr. Margaret Cortese (CDC/NCIRD) Discussion Dr. Wellington Sun (FDA) Dr. Len Friedland (GSK) Ms. Kim Dezura (Merck) 3:15 Public Comment 5 Advisory Committee on Immunization Practices (ACIP) Summary Report June 23-24, 2010 3:30 Adjourn Acronyms AAFP American Academy of Family Physicians AAP American Academy of Pediatrics ABCs Active Bacterial Core surveillance system ACHA American College Health Association ACP American College of Physicians ACIP Advisory Committee on Immunization Practices AGREE Appraisal of Guidelines Research and Evaluation AIAB Adult Immunization Advisory Board of ACP AEs Adverse Events AHIP America’s Health Insurance Plans AHRQ Agency for Healthcare Research and Quality AMA American Medical Association ANA American Nurses Association AOA American Osteopathic Association ARRA American Recovery and Reinvestment Act ASTHO Association of State and Territorial Health Officials BLA Biologics License Application BRFSS Behavioral Risk Factor Surveillance System CBER Center for Biologics Evaluation and Research CDC Centers for Disease Control and Prevention CEAS Clinical Efficacy Assessment Subcommittee of ACP CER Comparative Effectiveness Research CIDP chronic inflammatory demyelinating polyneuropathy CLL childhood lymphoblastic leukemia CMS Centers for Medicare and Medicaid Services COGS Conference on Guideline Standardization COI Conflict of Interest COID Committee on Infectious Diseases of AAP COPD Chronic Obstructive Pulmonary Disease CSAPH Council on Science and Public Health of AMA CSTE Council of State and Territorial Epidemiologists CVD Cardiovascular Disease DHQP Division of Healthcare Quality Promotion DoD Department of Defense DSMB Data Safety Monitoring Board DVA Department of Veterans Affairs DVH Division of Viral Hepatitis (of NCIRD) EBV Epstein-Barr Virus EBRWG Evidence Based Recommendations Work Group’s EIP Emerging Infections Program EMR Electronic Medical Records FDA Food and Drug Administration GAVI Global Alliance for Vaccines and Immunisation GBS Guillain Barré Syndrome GMCs Geometric Mean Concentrations GMTs Geometric Mean Titers GRADE Grades of Recommendation Assessment, Development and Evaluation GSK GlaxoSmithKline 6 Advisory Committee on Immunization Practices (ACIP) Summary Report June 23-24, 2010 HGT Horizontal gene transfer HICPAC Healthcare Infection Control Practices Advisory Committee HepA Hepatitis A HepB Hepatitis B HHS Department of Health and Human Services Hib Haemophilus influenzae B HPV Human Papillomavirus HRSA Health
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