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Advisory Committee on Immunization Practices (ACIP) How it works and current discussions Mark H. Sawyer, MD Professor of Clinical Pediatrics UCSD School of Medicine Who makes the decisions about what vaccines are given? Federal Drug Administration (FDA) – Vaccines and Related Biologics Advisory Committee Centers for Disease Control (CDC) – Advisory Committee on Immunization Practices California State Department of Public Health Professional Associations – – – American Academy of Pediatrics (AAP) American Association of Family Physicians (AAFP) American College of Obstetrics and Gynecology (ACOG) – American College of Physicians (ACP) Who makes the decisions about what vaccines are given? Individual healthcare organizations – Hospitals – Managed care organizations – Preferred Provider Organizations (PPO) Individual Physicians in consultation with patients/parents ACIP Function Advisory to CDC and HHS regarding the appropriate selection and use of vaccines and related agents for control of vaccinepreventable diseases in the civilian population. Establish the list of vaccines for administration through the Vaccines for Children Program (VFC) ACIP Structure CDC Leadership from NCIRD Executive Secretary-Dr. Larry Pickering 15 voting members with broad expertise – Infectious Disease – Pediatrics – Family Practice/Internal Medicine – Public Health – Nursing – Community ACIP Structure-Liaison Members AAP AAFP ACP AMA ACOG SAM NMA ACHA AGS AHIP AOA APhA APTR SHEA HICPAC BIO PhRMA IHS DOD DVA HRSA CMS NIH FDA NVPO NACCHO NACI DOH, UK NICCHP, Mexico The Work of ACIP Three open meetings/year Published agenda Action items brought by Work Groups to address a specific vaccine or vaccine question Final recommendations must be approved by CDC/HHS Recommendations published in MMWR The Real Work of ACIP Workgroups assembled to deal with each issue facing ACIP Each WG is chaired by an ACIP member but has many non-ACIP members with expertise in the topic Workgroups meet regularly (usually monthly) by conference call Review all relevant data, published and unpublished on the topic Discuss the policy implications of potential recommendations Present options for full ACIP to vote on Considerations for Recommending a New Vaccine Burden and risk of disease in the community Effectiveness of the vaccine Safety of the vaccine Cost-benefit analysis Feasibility/Vaccine Availability Cost/reimbursement for providers Patient/parental preferences Current Topics Under Discussion at ACIP MMRV HPV for boys and older women PCV 13 Hepatitis A and B updates Pertussis Rabies General Recommendations MMRV Apparent approximately 2x-increased rate of febrile seizures with MMRV compared to MMR + V ACIP has already stated no preference between MMRV or MMR + V Current WG reviewing this policy HPV for boys and older women ACIP has heard presentations on potential impact of HPV on boys and preliminary clinical trial data Future presentations on final clinical trial results Review cost-benefit studies ACIP has heard cost-benefit studies of HPV in women over age 26 Coming soon-recommendations for boys and older women PCV 13 ACIP has heard several presentations on PCV13 clinical trials in children Future presentations on PCV13 clinical trials in adults Coming soon-updated PCV recommendations once PCV13 is licensed Hepatatis A and B Recently recommended Hep A vaccine for non-travelling close contacts of international adoptees Reviewing outbreaks of Hep B in adult long-term care facilities Will review current data on duration of Hep B immunity following infant immunization Will review data on duration of immunity for Hep A Pertussis Consolidate existing recommendations into one Clarify the interval between previous Td and Tdap Review new data being developed on use of Tdap in pregnant women Review data on need for antibiotic prophylaxis in immunized HCW pertussis contacts Rabies ACIP heard data supporting reducing the rabies vaccine series from 5 doses to 4 doses Coming soon: ? Change in recommendation for number of doses General Recommendations Ask Sandra Jo Hammer Questions?