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June 2006 ACIP Meeting Minutes

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June 2006 ACIP Meeting Minutes DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR DISEASE CONTROL AND PREVENTION NATIONAL IMMUNIZATION PROGRAM Advisory Committee on Immunization Practices June 29-30, 2006 Atlanta, Georgia Record of the Proceedings This document has been archived for historical purposes. (7/1/2006) TABLE OF CONTENTS Page Attachment 1: List of Participants ...........................................................................................................A1.1 Attachment 2: Acronyms Used In This Report........................................................................................A2.1 Minutes of the Meeting.................................................................................................................................. 1 June 29, 2006 Opening Session .................................................................................................................................... 1 HUMAN PAPILLOMAVIRUS VACCINE................................................................................................. 2 Overview .......................................................................................................................................... 2 GARDASIL® Efficacy and Safety Data............................................................................................. 3 GARDASIL® Risk Management Plan............................................................................................... 7 GARDASIL® Post-Marketing Safety Surveillance............................................................................ 9 Potential Cost-Effectiveness of HPV Vaccination in the United States ......................................... 10 Public Comment Period ................................................................................................................. 12 Proposed Recommendations for the Quadrivalent HPV Vaccine.................................................. 16 ACIP Vote on the HPV Vaccine ..................................................................................................... 18 Proposed VFC Resolution ............................................................................................................. 21 ACIP Vote on the Proposed VFC Resolution ................................................................................ 21 VARICELLA VACCINE......................................................................................................................... 22 Update on Varicella Epidemiology ................................................................................................. 22 Immune Responses to One and Two Doses of Varicella Vaccine ................................................ 24 Projected Benefits and Costs of a Second Dose of Varicella Vaccine .......................................... 26 State Health Department Perspective on Varicella Outbreak Response ...................................... 27 Consideration of a Universal Two-Dose Recommendation for Varicella Immunization ................ 28 ACIP Vote on the Varicella Vaccination Policy .............................................................................. 33 Proposed VFC Resolution ............................................................................................................. 35 ACIP Vote on the Proposed VFC Resolution ................................................................................ 35 INFLUENZA VACCINE......................................................................................................................... 36 Next Steps in Decreasing Influenza-Associated Morbidity and Mortality Through Annual Vaccination .................................................................... 36 One Versus Two Doses of Trivalent Inactivated Influenza Vaccine in Influenza Vaccine-Naïve Children.................................................................................................. 39 Options for Children Who Were Not Fully Vaccinated Initially....................................................... 40 ACIP Vote on Options for Children Who Were Not Fully Vaccinated Initially................................ 41 Options for Tiered Use of TIV ........................................................................................................ 42 ACIP Vote on Options for Tiered Use of TIV ................................................................................. 44 ISO Update........................................................................................................................................... 45 Public Comment Period........................................................................................................................ 47 This document has been archived for historical purposes. (7/1/2006) TABLE OF CONTENTS Page June 30, 2006 Update on Menactra® Supply and Prioritization ................................................................................... 48 Tdap VACCINE IN PREGNANT WOMEN ........................................................................................... 49 Pertussis Workgroup Report.......................................................................................................... 50 Considerations for Tdap in Pregnant Women................................................................................ 50 Draft Recommendations for Tdap in Pregnant Women................................................................. 53 ACIP Vote on the Draft Recommendations for Tdap in Pregnant Women.................................... 55 Adult Immunization Schedule for October 2006-September 2007....................................................... 57 Update on Pneumococcal Vaccines..................................................................................................... 57 HERPES ZOSTER (SHINGLES) VACCINE ........................................................................................ 60 Evaluation of the Vaccine Cost-Effectiveness ............................................................................... 60 Projected Cost Effectiveness of Vaccinating the Elderly to Prevent Shingles............................... 63 Overview of the ZOSTAVAX® Storage, Handling and RMP .......................................................... 66 Considerations for Shingles Vaccine Recommendations in the United States ............................. 67 Childhood/Adolescent Immunization Schedule for 2007...................................................................... 70 Update on the Multi-State Mumps Outbreak in the United States ....................................................... 73 Update on the Rotavirus Vaccine......................................................................................................... 76 Ex- Officio Reports................................................................................................................................ 77 Public Comment Period........................................................................................................................ 78 Closing Session.................................................................................................................................... 79 This document has been archived for historical purposes. (7/1/2006) Page A1.1 ATTACHMENT 1 List of Participants ACIP Members Dr. Bruce Gellin Dr. Jon Abramson, Chair National Vaccine Program Office Dr. Ban Mishu Allos Mr. Robert Beck Dr. Andrea Gelzer Dr. Judith Campbell America’s Health Insurance Plans Dr. Reginald Finger Dr. Janet Gilsdorf Dr. Karen Goldenthal Dr. Harry Hull Food and Drug Administration Dr. Tracy Lieu Dr. Edgar Marcuse Dr. Samuel Katz Dr. Julia Morita Infectious Diseases Society of America Dr. Dale Morse Dr. Gregory Poland Dr. Clement Lewin Ms. Patricia Stinchfield Biotechnology Industry Organization Dr. John Treanor Dr. Robin Womeodu Dr. Cody Meissner American Academy of Pediatrics Designated Federal Official Dr. Larry Pickering Dr. Amy Middleman ACIP Executive Secretary Society for Adolescent Medicine Liaison and Ex- Officio Representatives Ms. Linda Murphy Dr. Carol Baker Centers for Medicare and Medicaid Services American Academy of Pediatrics Dr. Monica Naus Dr. Doug Campos-Outcalt Canadian National Advisory Committee on American Academy of Family Physicians Immunization Dr. James Cheek Dr. Kathleen Neuzil Indian Health Service American College of Physicians Dr. George Curlin Dr. Kristin Nichol [via conference call] National Institutes of Health Department of Veterans Affairs Dr. Geoffrey Evans Dr. Peter Paradiso Health Resources and Services Administration Pharmaceutical Research and Manufacturers of America Dr. Stephen Ford Department of Defense Dr. Keith Powell American Academy of Pediatrics Dr. Stephan Foster American Pharmacists Association Dr. Romeo Rodriquez National Immunization Council and Child Health Dr. Gary Freed Program, Mexico National Vaccine Advisory Committee Dr. William Schaffner Dr. Stanley Gall National Foundation for Infectious Diseases American College of Obstetricians and Gynecologists This document has been archived for historical purposes. (7/1/2006) Dr. Litjen Tan Dr. Hannah Jordan American Medical Association Dr. Pat Joyce Dr. Katrina Kretsinger Dr. Jonathan Temte Dr. Andrew Kroger American Academy of Family Physicians Dr. Derrick Lake Dr. Hershel Lawson Dr. James Turner Dr. Jessica Leung American College Health Association Dr. Susan Lett Ms. Nicole Liddon Dr. Patricia Whitley-Williams Dr. Suchita Lorick National Medical Association Dr. Susan Manning Dr. Mona
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