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ACIP Meeting Minutes DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR DISEASE CONTROL AND PREVENTION Advisory Committee on Immunization Practices February 21-22, 2007 Atlanta, Georgia Record of the Proceedings DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR DISEASE CONTROL AND PREVENTION ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES February 21-22, 2007 Atlanta, Georgia C O N T E N T S February 21, 2007 WELCOME AND INTRODUCTION………………………………………………………..1 HEPATITIS A POSTEXPOSURE PROPHYLAXIS ………………………………………..2 Introduction: Dr. Bell........................... ……………………………………………....2 Study Results: Dr. Victor........................ …………………………………………….2 ROTAVIRUS VACCINE …………………………………………………………………...12 General Update: Dr. Parashar......................................................................................13 Disease Burden: Dr. Payne........................ ………………………………………….14 VAERS: Ms. Haber.....................................................................................................15 Data Interpretation: Dr. Patel................... …………………………………………...16 THIMEROSAL: REVIEWING THE EVIDENCE ………………………………………….21 Dr. Lieberman VACCINE SUPPLY………………………………………………………………………….28 Dr. Wallace INFLUENZA…………………………………………………………………………………32 Update: Dr. Allos..........................................................................................................33 Information: Dr. Fiore...................................................................................................34 Vote...............................................................................................................................43 VFC Resolution: Dr. Calugar....................................................................................... 44 Pandemic Vaccine Prioritization: Dr. Schwartz...........................................................45 FluMist Safety Data: Dr. Walker.................. ………………………………………...49 PUBLIC COMMENT...............................................................................................................41 February 22, 2007 UNFINISHED BUSINESS Dr. Abramson..................................... ………………………………………………..55 ii DIPHTHERIA, TETANUS, PERTUSSIS, Hib, PENTACEL Dr. Joyce........................................ ………………………………………………….59 IMMUNIZATION SAFETY OFFICE SURVEILLANCE UPDATES Dr. Davis........................................ ………………………………………………….60 Dr. Iskander..................................................................................................................64 HUMAN PAPILLOMAVIRUS VACCINE Introduction: Dr. Gilsdorf....................... ……………………………………………68 Quadrivalent HPV Vaccine: Dr. Barr............... ……………………………………...69 Bivalent HPV Vaccine: Dr. Dubin............. ………………………………………….73 Working Group Update: Dr. Markowitz.....................................................................79 AGENCY UPDATES..............................................................................................................85 CLOSING SESSION ATTACHMENTS: PARTICIPANTS …………………………………………………………………….88 ACRONYMS…………………………………………………………………………93 iii DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR DISEASE CONTROL AND PREVENTION ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES February 21-22, 2007 Atlanta, Georgia Minutes of the Meeting The Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) National Center for Immunization and Respiratory Diseases (NCIRD) [proposed] convened a meeting of the Advisory Committee on Immunization Practices (ACIP). The meeting was held on February 21-22, 2007 at CDC’s Global Communications Center, Building 19, in Atlanta, Georgia. The list of participants is appended to the minutes as Attachment 1. [Note: the list of participants only includes persons who introduced themselves for the record, presented, made public comments, or registered prior to the meeting.] INTRODUCTION At 8:11, Dr. Abramson welcomed everyone to the February 2007 ACIP meeting. Dr. Pickering introduced several international visitors, including Dr. Eibhlin Connolly and Dr. Jim Kiely from the Department of Health and Children in Dublin, Ireland, as well as Dr. Keiko Taya, Infectious Diseases Surveillance Center in Wakayama City, Japan, and Dr. Takehiro Togashi from Sapporo City University, Japan. He also introduced new representatives of ACIP liaison organizations. Dr. Tamara Lewis, American Health Insurance Plans replaces Dr. Andrea Gelzer. Dr. Stanley Grogg represents a new liaison organization: the American Osteopathic Association. Dr. Vesta Richardson from the National Immunization Council of Child Health Program in Mexico replaces Dr. Romeo Rodriquez. Dr. Harry Keyserling represents the Society for Healthcare Epidemiology of America. Dr. Geoff Evans (HRSA) was unable to attend the meeting, so Dr. Jevaji attended on Dr. Evans’ behalf. Dr. David Kimberlin from the American Academy of Pediatrics was also unable to attend. Dr. Patricia Whitley-Williams from the National Medical Association also sent her regrets. Dr. Pickering noted that slide presentations would be posted on the ACIP Web site one to two weeks after the meeting. The ACIP home page is located at www.cdc.gov/nip/acip and is updated at frequent intervals to include meeting agendas, meeting minutes and presentations, ACIP recommendations, and other information related to immunization and ACIP activity. Dr. Pickering confirmed that there was a quorum of ACIP members present and explained that the ACIP charter gives the Executive Secretary or his or her designee the authority to temporarily designate the ex officio members as voting members if necessary. This would occur in the event that there are fewer than eight ACIP members available or who cannot vote because of conflicts of interest. The ex officio members will be formally requested to vote when necessary. If this occurs, they will be asked to express and disclose any potential 1 conflicts of interest. The goal in appointing members to the ACIP is to achieve the greatest level of expertise while minimizing the potential for actual or perceived conflicts of interest. The conflict of interest provisions state that members agree to forego participation in certain activities related to vaccines during their tenure on the committee. CDC has issued limited conflict of interest waivers for certain other interests that potentially enhance a member's expertise while serving on the committee. Members who conduct vaccine clinical trials or serve on data safety monitoring boards may serve as consultants to present to the committee on matters related to those vaccines. However, they are prohibited from participating in the deliberations or votes of the committee on issues related to those vaccines. Regarding other vaccines of an affected company, a member may participate in all discussions with the proviso that he or she abstains on all votes related to the vaccines of that company. All ACIP members must state their conflicts when they vote for a VFC resolution. ACIP members who may have a potential financial conflict of interest should make it known by disclosing all of their vaccine-related financial interests and work. Dr. Abramson asked ACIP members to state any conflicts of interest. Dr. Carol Baker stated she had a conflict with Novartis Vaccines. Dr. Janet Gilsdorf stated she was an independent safety monitor on an NIH-sponsored influenza trial, for which she receives no compensation. Dr. John Treanor said his group was involved in clinical trails of influenza or pneumococcal vaccines for sanofi, Protein Sciences, Wyeth, Novartis and Merck. Dr. Lieberman stated that he was involved in clinical trials with Merck and MedImmune. Dr. Abramson stated that he served on a Data Safety Monitoring Board for an NIH-sponsored study of the use of oseltamivir in infants, and he received no compensation for this study. HEPATITIS A POSTEXPOSURE PROPHYLAXIS Dr. Beth Bell, National Center for HIV, Hepatitis, STD and TB Prevention (NCHHSTP), CDC Dr. John Victor, PhD., Department of Epidemiology, School of Public Health, University of Michigan Dr. Bell explained the current ACIP recommendation with respect to hepatitis A post- exposure prophylaxis calls for a single dose of IG as soon as possible but within two weeks of exposure; if hepatitis A vaccine also is recommended, it can be administered simultaneously with IG. The statement does address the question of the use of hepatitis A vaccine alone, saying results of an appropriately designed clinical trial comparing the post-exposure efficacy of vaccine with that of IG are needed to determine if hepatitis A vaccine without IG can be recommended. With this question in mind, about five years ago a trial was funded to compare the efficacy of hepatitis A vaccine to IG after exposure to hepatitis A virus, through a cooperative agreement with the University of Michigan’s School of Public Health. Dr. John Victor presented the results of that study. As background, he showed post-exposure efficacy estimates for IG from the published literature. Most of the studies were done before the advent of serologic tests. For the most part, these efficacy estimates were quite high and support the notion that IG is at least 85 percent effective for post-exposure prophylaxis. 2 Unlike most pre-exposure trials, in a post-exposure study potential participants must be ascertained within a relatively short time period after exposure, which is logistically difficult. Identification of cases and their contacts for potential post-exposure prophylaxis requires
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