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Advisory Committee on Immunization Practices (ACIP) DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR DISEASE CONTROL AND PREVENTION Advisory Committee on Immunization Practices (ACIP) Summary Report October 21, 2015 Atlanta, Georgia This document has been archived for historical purposes. (11/1/2015) Advisory Committee on Immunization Practices (ACIP) Summary Report October 21, 2015 Table of Contents Page Agenda 4-6 Acronyms 7-10 Welcome and Introductions 11-16 Agency Updates Centers for Disease Control and Prevention (CDC) Center for Medicare and Medicaid Services (CMS) Department of Defense (DoD) Department of Veteran’s Affairs (DVA) 16-19 Food and Drug Administration (FDA) Heath Resources and Services Administration (HRSA) Indian Health Services (I HS) National Institutes of Health (NIH) National Vaccine Advisory Committee (NVAC) National Vaccine Program Office (NVPO) Child and Adolescent Immunization Schedule Introduction 19-24 2016 Child and Adolescent Immunization Schedule Adult Immunization Schedule Introduction Erratum in 2015 Adult Immunization Schedule 24-29 2016 Adult Immunization Schedule Meningococcal Vaccine Introduction 30-40 Serogroup C Outbreak among Men Who Have Sex with Men (MSM), Chicago 2015 Influenza Introduction Epidemiology and Surveillance Update Cost-Effectiveness of High-Dose Versus Standard-Dose Inactivated Influenza Vaccine in Adults Aged 40-55 65 and Older Adjuvanted Trivalent Influenza Vaccine Vaccine Supply 55-58 Human Papillomavirus (HPV) Vaccines Introduction HPV Vaccine Coverage in the US, NIS-Teen 2014 Programmatic Strategies to Increase HPV Vaccine Coverage 58-77 Update on HPV Vaccine Safety Monitoring Impact of the HPV Vaccination Program HPV Vaccines Work Group Plans 2 This document has been archived for historical purposes. (11/1/2015) Advisory Committee on Immunization Practices (ACIP) Summary Report October 21, 2015 Japanese Encephalitis (JE) Vaccine Introduction Change in JE Vaccine Distributor Immunogenicity in Older Adults 77-85 Co-Administration with Rabies Vaccine Alternative Dosing Schedule JE Vaccine Work Group Plans Combination Vaccines Introduction 85-91 Pediatric Hexavalent Vaccine (DTaP-IVP-Hib-HepB), Merck/Sanofi Cholera Vaccine Introduction 91-97 Cholera in US Travelers Ebola Vaccine Trial Update 97-104 Public Comment 106-108 Certification 109 Membership Roster 110-118 Appendix A: Public Comment Letter Received 119-122 3 This document has been archived for historical purposes. (11/1/2015) Advisory Committee on Immunization Practices (ACIP) Summary Report October 21, 2015 MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP) Centers for Disease Control and Prevention 1600 Clifton Road, NE, Tom Harkin Global Communications Center, Kent "Oz" Nelson Auditorium Atlanta, Georgia 30329 October 21, 2015 (1-day meeting) AGENDA ITEM PURPOSE PRESIDER/PRESENTER(s) Wednesday, October 21st 8:00 Welcome & Dr. Nancy Bennett (ACIP Chair) Introductions Dr. Ray Strikas (Acting ACIP Executive Secretary; CDC) 8:30 Agency Updates CDC, CMS, DoD, DVA, FDA, HRSA, IHS, NIH, Information CDC and ex officio members NVPO 8:45 Child and Adolescent Immunization Schedule Introduction Dr. Jose Romero (ACIP, WG Information, Chair) Discussion 2016 child and adolescent immunization Dr. Candice Robinson Vote schedule (CDC/NCIRD) 9:30 Adult Immunization Schedule Introduction Information Dr. Kathleen Harriman (ACIP, & Discussion WG Chair) Erratum in 2015 adult immunization Dr. David Kim (CDC/NCIRD) schedule 2016 adult immunization schedule update Vote 10:00 Break 10:30 Meningococcal Vaccines Introduction Information Dr. Lorry Rubin (ACIP, WG & Discussion Chair) Serogroup C outbreak among men who Dr. Sarah Kemble (Chicago have sex with men (MSM), Chicago, 2015 DPH) 11:15 Influenza Introduction Dr. Ruth Karron (ACIP, WG Chair) Epidemiology and surveillance Update Ms. Lynnette Brammer (CDC/NCIRD) Information Cost-effectiveness of high-dose versus Dr. Ayman Chit (Sanofi & Discussion standard-dose inactivated influenza vaccine Pasteur) in adults aged 65 years and older Adjuvanted trivalent influenza vaccine Dr. Kelly Lindert (NVS Influenza Vaccines) 4 This document has been archived for historical purposes. (11/1/2015) Advisory Committee on Immunization Practices (ACIP) Summary Report October 21, 2015 12:15 Vaccine Dr. Jeanne Santoli Supply (CDC/NCIRD) 12:20 Lunch 1:35 Human Papillomavirus (HPV) Vaccines Introduction Dr. Allison Kempe (ACIP, WG Chair) HPV vaccine coverage in the US, NIS-Teen Dr. Sarah Reagan-Steiner 2014 (CDC/NCIRD) Programmatic strategies to increase HPV vaccine coverage Information Dr. Robin Curtis (CDC/NCIRD) Update on HPV vaccine safety & Discussion Dr. Lakshmi Sukumaran, (CDC/NCEZID) Monitoring impact of the HPV vaccination Dr. Lauri Markowitz program (CDC/NCHHSTP) HPV Vaccines Work Group plans Dr. Lauri Markowitz (CDC/NCHHSTP) 2:35 Japanese Encephalitis (JE) Vaccine Introduction Dr. Lorry Rubin (ACIP, WG Chair) Change in JE vaccine distributor; Dr. Katrin Dubischar (Valneva) Information immunogenicity in older adults; co- & Discussion administration with rabies vaccine; alternative dosing schedule JE Vaccine Work Group plans Dr. Susan Hills (CDC/NCEZID) 3:25 Break 3:50 Combination Vaccine Introduction Dr. Art Reingold (ACIP, WG Information Chair) Pediatric hexavalent vaccine (DTaP-IPV-Hib- & Discussion Dr. Andrew Lee (Merck) HepB), Merck/Sanofi 4:35 Cholera Vaccine Introduction Information Dr. Art Reingold (ACIP, WG & Discussion Chair) Cholera in U.S. travelers Dr. Karen Wong (CDC/NCEZID) 5:10 Ebola Vaccine Trial Update Information Dr. Susan Goldstein, CDC Ebola Response Team 5:45 Public Comment 6:00 Adjourn 5 This document has been archived for historical purposes. (11/1/2015) Advisory Committee on Immunization Practices (ACIP) Summary Report October 21, 2015 Acronyms CDC Centers for Disease Control & Prevention CMS Centers for Medicare and Medicaid Services DoD Department of Defense DTaP-IPV-Hib- Diphtheria, tetanus, acellular pertussis, inactivated polio, Haemophilus influenzae type HepB B and hepatitis B DVA Department of Veterans Affairs FDA Food and Drug Administration GRADE Grading of Recommendations Assessment, Development and Evaluation HRSA Health Resources and Services Administration IHS Indian Health Service MSM Men who have sex with men NCHHSTP National Center for HIV, Hepatitis, STD and TB Prevention [of CDC/OID] NCIRD CDC National Center for Immunization & Respiratory Diseases [of CDC/OID] NCEZID National Center for Emerging and Zoonotic Diseases [of CDC/OID] NIH National Institutes of Health NIS National Immunization Survey NVPO National Vaccine Program Office VFC Vaccines for Children WG Work Group 6 This document has been archived for historical purposes. (11/1/2015) Advisory Committee on Immunization Practices (ACIP) Summary Report October 21, 2015 Acronyms Used in This Document AAFP American Academy of Family Physicians AAP American Academy of Pediatrics ACA Affordable Care Act ACIP Advisory Committee on Immunization Practices ACNM American College of Nurse Midwives ACOG American Congress of Obstetricians and Gynecologists ACP American College of Physicians ACS American Cancer Society AE Adverse Events AFIX Assessment, Feedback, Incentives, and eXchange AFP American Family Physicians aHCST Autologous Hematopoietic Stem Cell Transplant AMA American Medical Association ANA American Nurses Association APA Academic Pediatric Association APD Adequate Provider Data ASTHO Association of State and Territorial Health Officials aTIV Adjuvanted Trivalent Inactivated Influenza Viral Vaccine BARDA Biomedical Advanced Research and Development Authority BIO Biotechnology Industry Organization BLA Biologics License Application CBER Center for Biologics Evaluation and Research CBO Community-Based Organization CCH Center for Community Health (URMC) CDC Centers for Disease Control and Prevention CDPH Chicago Department of Public Health ChAd3-EBO Z Chimpanzee Adenovirus 3-Based Vaccine CICP Countermeasures Injury Compensation Program CID Clinical Infectious Diseases CIN Cervical Intraepithelial Neoplasia CISA Project Clinical Immunization Safety Assessment Project CMS Center for Medicare and Medicaid COI Conflict of Interest COID Committee on Infectious Disease, AAP COMAHS College of Medicine and Allied Health Sciences CRPS Complex Regional Pain Syndrome CSF Cerebrospinal Fluid CSTE Council of State and Territorial Epidemiologists CTSI Clinical & Translational Science Institute (URMC) CVD Cardiovascular Disease DC District of Columbia DCPC Division of Cancer Prevention and Control DM Diabetes Mellitus DNA deoxyribonucleic acid DoD Department of Defense DSMB Data Safety Monitoring Board DVA Department of Veterans Affairs EBR Evidence-Based Recommendations ED Emergency Department EHR Electronic Health Record EIP Emerging Infections Program 7 This document has been archived for historical purposes. (11/1/2015) Advisory Committee on Immunization Practices (ACIP) Summary Report October 21, 2015 EIS Epidemic Intelligence Service EMA European Medicines Agency ENT Ear, Nose, and Throat Epi-X Epidemic Information Exchange ETEC Enterotoxigenic E. coli EU European Union EVD Ebola Virus Disease FDA Food and Drug Administration FHA Filamentous Hemagglutinin FLU VE Influenza Vaccine Effectiveness Network FOA Funding Opportunity Announcement FY Fiscal Year GBS Guillain-Barré Syndrome GDPH Georgia Department of Public Health GEVIT Global Ebola Vaccine Implementation Team GMC Geometric Mean Concentrations GMT Geometric Mean Titers GRADE Grading of Recommendation Assessment, Development and Evaluation
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