Advisory committee on immunization practices




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CENTERS FOR DISEASE CONTROL AND PREVENTION


NATIONAL IMMUNIZATION PROGRAM


RECORD OF THE MEETING OF THE


ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES


October 26-27, 2005


Meeting held at the Atlanta Marriott Century Center Hotel

Atlanta, Georgia


This report is 78 pages long.


Acronyms used in this report

A.A.F.P. - American Academy of Family Practitioners

A.A.P. - American Academy of Pediatrics

A.C.H.A. - American College Health Association

A.C.I.P. - Advisory Committee on Immunization Practices

A.M.A. - American Medical Association

A.P.E.R.T. - Acellular Pertussis Efficacy Randomized Trial

C.D.C. - Centers for Disease Control and Prevention

C.E. - Cost Effectiveness

C.I.N. - Cervical Intraepithelial Neoplasia

C.I.S.A. - Clinical Immunization Safety Assessment Network

C.M.I. - Cell-Mediated Immunity

C.N.S. - Central Nervous System

C.O.I.D. - Committee on Infectious Disease (A.A.P.)

C.O.P.D. - Chronic Obstructive Pulmonary Disease

D.A.L.Y.S. - Dollars-Per-Life-Year Saved

D.H.H.S. - Department of Health and Human Services

D.S.M.B. - Data Safety Monitoring Board

D.T.a.P. - Diphtheria, Tetanus, Acellular Pertussis (vaccine)

D.T.w.P. - Diphtheria, Tetanus, Wholecell Pertussis (vaccine)

D.T.P. - Diphtheria, Tetanus, Pertussis

E.D. - Emergency Department

E.L.I.S.A. - Enzyme-Linked Immunosorbent Assay

E.L.S. - Extensive Limb Swelling

F.D.A. - Food and Drug Administration

G.B.S. - Guillain-Barré Syndrome

G.I. - Gastrointestinal

G.M.C. - Granulocyte Macrophage Colony

G.M.T. - Geometric Mean Titer

G.p. - Glycoprotein

G.S.K. - GlaxoSmithKline

H.A.V. - Hepatitis A Virus

H.B.s.A.g. - Hepatitis B Surface Antigen

H.B.V. - Hepatitis B Virus (Vaccine)

H.I.V./AIDS - Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome

H.P.V. - Human Papillomavirus

H.Z. - Herpes Zoster

H.Z.O. - Ophthalmic Herpes Zoster

I.A.C. - Immunization Action Coalition

I.g. - Immune Globulin (I.g.A, class A; I.g.G, class G)

I.G.I.V. - Immune Globulin Intravenous

I.S.O. - Immunization Safety Office

I.D. - Intradermal

I.D.U. - Intravenous Drug User

I.M. - Intramuscular

I.N.D. - Investigational New Drug

I.O.M. - Institute of Medicine

L.A.I.V. - Live Attenuated Influenza Vaccine

L.A.I.V.C. - Live Attenuated Influenza Vaccine - Cold (adapted)

M.B.P.H.L./M.B.L. - Massachusetts Biologics Public Health Laboratory

M.C.V. - Meningococcal Conjugate Vaccine

M.I.T.T. - Modified Intention To Treat

M.M.R.V. - Measles, Mumps, Rubella, Varicella

M.M.W.R. - Morbidity and Mortality Weekly Report

M.P.S.V. - Meningococcal Polysaccharide Vaccine

M.S.M. - Men Who Have Sex With Men

N.C.H.S. - National Center for Health Statistics

N.C.H.S.T.P. - National Center for H.I.V., S.T.D. and TB Prevention

N.C.I.D. - National Center for Infectious Disease

N.H.I.S. - National Health Interview Survey

N.I. - Neuraminidase Inhibitor

N.I.A.I.D. - National Institute for Allergy and Infectious Diseases

N.I.H. – National Institutes of Health

N.I.P. - National Immunization Program

N.I.S. – National Immunization Survey

N.N.D.S.S. - National Notifiable Disease Surveillance System

N.V.P.O. - National Vaccine Program Office

O.P.V. - Oral Poliovirus Vaccine

P.E.P. - Post-Exposure Prophylaxis

P.H.N. - Postherpetic Neuralgia

P.R.V. - Pentavalent Bovine-Human Rotavirus Vaccine

Q.A.L.Y. - Quality-Adjusted Life-Years

Q.A.L.Y.S. - Quality-Adjusted Life-Year Saved

R.E.S.T. - Rotavirus Efficacy and Safety Trial

R.T.I. - Research Triangle Institute

S.T.D. - Sexually Transmitted Disease

T.I.V. - Trivalent Influenza Vaccine

U.S.P.S.T.F. - U.S. Preventive Services Task Force

V.A.E.R.S. - Vaccine Adverse Event Reporting System

V.a.I.N. - Vaginal Intraepithelial Neoplasia

V.I.N. - Vulvar Intraepithelial Neoplasia

V.A.P.P. - Vaccine Associated Paralytic Polio

V.E. - Vaccine Efficacy

V.F.C. - Vaccines for Children (Program)

V.S.D. - Vaccine Safety Datalink

V.T.E.U. - Vaccine Treatment Evaluation Unit

V.Z.I.G. - Varicella Zoster Immune Globulin

V.Z.V. - Varicella Zoster Virus

W.H.O. - World Health Organization


Table of Contents

MINUTES OF THE MEETING

OPENING COMMENTS

AGENDA ITEMS

HEPATITIS

Hepatitis B Vaccine Recommendations for Adults

Hepatitis B Working Group Discussions

PUBLIC COMMENT

VARICELLA

Varicella Zoster Immune Globulin (V.Z.I.G.)

F.D.A. Update on V.Z.I.G. Status/New Product

Varicella Zoster Virus and P.E.P. Options

Issues Related to P.E.P. with V.Z.I.G. or I.G.I.V. Use

HEPATITIS A

Recommendations for Hepatitis A Vaccination of Children

Working Group Discussions/Economic Analyses

V.F.C. Resolution Vote

PERTUSSIS

A.C.I.P. Pertussis Vaccine (Tdap) Working Group

Efficacy/Safety of Tdap Use among Adults

Post-licensure Safety of Tdap and Td in Adults

Pertussis in Adults

Economics and Cost Effectiveness of Adult Pertussis Vaccination

Physician Perspectives on Tdap Administration to Adults

Working Group Recommendations on A.C.I.P. Decision for Tdap Use Among Adults

Public Comment

Proposed Recommendation

Tdap Use in Pregnancy

Possible Association of M.C.V.4 (Menactra®) with G.B.S.

Update on Isolation of Vaccine-Derived Polioviruses from Five Children in Minnesota

PUBLIC COMMENT

OCTOBER 27, 2005

V.F.C. VOTE ON HEPATITIS A VACCINE

UNIVERSAL INFLUENZA VACCINATION

HARMONIZED SCHEDULE

ROTAVIRUS

Cost Effectiveness of Rotavirus Vaccine

Rotavirus Vaccination Related To Other Selected Childhood Immunizations

Draft Recommendations for Pentavalent Bovine-Human Rotavirus (P.R.V.) Vaccine

MEASLES, MUMPS, RUBELLA and VARICELLA COMBINATION VACCINE

V.F.C. Resolution

HUMAN PAPILLOMAVIRUS VACCINE

Gardasil™ H.P.V. Vaccine

C.D.C. Survey of Sentinel Pediatricians on H.P.V. Vaccine Acceptability

REVISION TO THE 2002 A.C.I.P. GENERAL RECOMMENDATIONS

HERPES ZOSTER VACCINE

INFLUENZA

Vaccine Supply

Influenza Resistance to Antiviral Drugs

AVIAN INFLUENZA H5N1

Update on H5N1

Update on H5N1 Vaccine Clinical Trial

CLOSING COMMENTS

Attachment #1: Attendance


CENTERS FOR DISEASE CONTROL AND PREVENTION

NATIONAL IMMUNIZATION PROGRAM

ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES


MINUTES OF THE MEETING - OCTOBER 26-27, 2005


OCTOBER 26, 2005


A meeting of the Advisory Committee on Immunization Practices (A.C.I.P.) was convened by the Centers for Disease Control and Prevention’s (C.D.C.) National Immunization Program (N.I.P.) at the Atlanta Marriott Century Center Hotel in Atlanta, Georgia, on October 26-27, 2005. The meeting agenda was posted on C.D.C.’s Website. The meeting was convened at 8:38 a.m. by A.C.I.P. Chairman Dr. Jon Abramson, who welcomed all in attendance (see Attachment #1).


OPENING COMMENTS


A.C.I.P. Executive Secretary Dr. Larry Pickering made several announcements:

  • He welcomed three distinguished visitors from China: Dr. Cui Gang, Director, Ministry of Health, Epidemiology Division; Dr. Liang Xiaogeng, Director, National Immunization Program of China; and Dr. Xu Aiqiang, Deputy Director, Shangdon Provincial Center for Disease Control.

  • Members newly appointed were Mr. Robert Beck, A.C.I.P. consumer representative, Dr. Harry Hull, Minnesota State Epidemiologist, and Dr. Dale Morse, New York State Department of Health (not present at this meeting).

  • New liaisons were: Dr. Keith Powell, American Academy of Pediatrics, and Dr. Patricia Whitley-Williams, National Medical Association

  • This was the last meeting for Dr. Richard Clover, who was thanked for his many years of service to the committee. During the meeting, Dr. Abramson also thanked Ms. Dee Gardner for her excellent work in coordinating the A.C.I.P. meetings.

  • The A.C.I.P. home page is http://www.cdc.gov/nip/acip ­­and the e-mail address is mailto:acip@cdc.gov

  • The 2006 A.C.I.P. meeting dates are February 21-22, June 26-27, and October 24-25.

  • A.C.I.P. Protocol: A quorum of A.C.I.P. members must be maintained to conduct committee business. In the absence of a quorum (eight members) qualified to vote, the A.C.I.P. charter allows the Executive Secretary to temporarily designate ex officio members as voting members. If voting, the ex officio members are asked to disclose any potential conflicts of interest. A.C.I.P. members with potential conflicts of interest are asked to disclose all vaccine-related work and financial interests, and to refrain from any discussion or vote that is related to such matters. When needed, however, limited waivers of such conflicts of interest can be granted to enable the members to provide their expertise to the Committee. Waivers may be issued, for example, to members who also conduct clinical vaccine trials, or who serve on a Data Safety Monitoring Board (D.S.M.B.). Those members may provide information to the committee and discuss other vaccines produced by the same company, but they may not participate in discussion on the vaccine involving their conflict, nor in any related votes.

  • Meeting time is reserved for public comment at scheduled intervals, but may also occur during open discussion if a speaker is recognized by the Chair and time permits.


The members and liaisons then introduced themselves (see Attachment #1). Those reporting potential conflicts of interest were Mr. Beck (awaiting a decision from the Office of General Counsel about stock), Dr. Gilsdorf (I.N.D. safety monitor for an N.I.H. vaccine trial, but not compensated), and Dr. John Treanor (clinical trials for laboratory studies underway or pending grant support, for: Alphavax, Protein Sciences, Merck, PowderMed, EpImmune, and I.D. Biomedical (which is being purchased by GlaxoSmithKline, or G.S.K.). Dr. Tracy Lieu had no conflicts but reported receiving research support from the C.D.C.


AGENDA ITEMS


HEPATITIS


Hepatitis B Vaccine Recommendations for Adults

Presenter: Dr. Eric Mast, N.C.I.D.


Overview: Background/rationale for adult hepatitis B virus (H.B.V.) vaccination strategies; proposed adult hepatitis B vaccine recommendations


Background. A.C.I.P. has recommended vaccination for adults at risk for H.B.V. infection since 1982, but implementation has been poor. Many health care settings do not vaccinate high risk adults and vaccine coverage among high risk adults is low. Clearly, new implementation strategies are needed.


The process to develop new recommendations began in October of 2004, with an overview presented to the A.C.I.P. Draft recommendations were posted for public comment on the Division of Viral Hepatitis (DVH) web site from January 28-March 4, 2005. The childhood statement was approved at the June 2005 A.C.I.P. meeting. Input has been received since the distributed of the February 2005 draft recommendations, from the A.C.I.P. and its Hepatitis Vaccine Working Group, from the public and from C.D.C. staff. An external consultation was also held in May to discuss implementation barriers in the public and private sectors and the strategies or experiences that could address them.


In response to this input, expanded implementation recommendations were developed. These provide guidance on setting-specific strategies to reach adults, including specific recommendations to address barriers. They also have guidance on vaccination in primary care settings, including option for age-based vaccination in situations where risk assessment is not feasible.


Information is also provided in the statement about hepatitis B surface antigen (H.B.s.A.g.) testing as a component of hepatitis B vaccination services. Racial-ethnic disparities in disease burden are discussed, as is the rationale for identification and management of H.B.s.A.g.-positive persons. A separate section provides the recommendations for hepatitis B serologic testing in routine immunization activities.


A Working Group was formed to prepare proposed A.C.I.P. adult hepatitis B vaccine recommendations. The Working Group will draft recommendations, propose funding (a draft proposal is in C.D.C. review), prepare program guidance, plan health education and communication strategies, and identify the data needed to evaluate implementation.


Data from 1990-2004 were charted on 1) U.S. cases of acute hepatitis B incidence by age group and race/ethnicity to age 20 years, and 2) 2002 vaccine coverage for all age groups, and reported acute hepatitis B incidence in 2004 by age and sex. Reported risk characteristics among U.S. adults with acute hepatitis B (2001-2003) included high risk behavior heterosexuals ( greater than 1 sex partner in prior 6 months, sexual contact with H.B.s.A.g.-positive person) (39 percent), men who have sex with men (M.S.M. ─ 25 percent), injection drug users (I.D.U. ─ 14 percent), and other exposures (household contact, institutionalization, hemodialysis, blood transfusion, occupational exposure) (7 percent). About 15 percent had no identified risk.


In primary care and specialty medical settings, the data indicate that risk-targeted vaccination is the most efficient delivery method because only approximately 15 to 20 percent of all adults report risk factors for infection that would make them a candidate for vaccination. Risk identification has also been recommended by the A.A.F.P., A.M.A., U.S.P.S.T.F. In addition to hepatitis B vaccination, many persons at risk for H.B.V. infection have other prevention needs (for example, screening for H.I.V. and S.T.D.s, or drug abuse treatment).


Of those who had acute hepatitis B from 2001 to 2004, 61 percent had prior opportunities for vaccination (in detention, or at S.T.D. or substance abuse clinics). Demonstration projects in high-risk settings have established the needed program components to successfully implement adult hepatitis B vaccination. They have also demonstrated the feasibility of delivery in S.T.D., H.I.V./AIDS and hepatitis prevention services, achieving a 75 percent to 85 percent first-dose acceptance rate. Funding for vaccine and administration was identified as the primary barrier to implementation in these settings.

The barriers to hepatitis B vaccination in primary care and specialty medical settings were identified and addressed in the implementation recommendations:

  • The lack of an adult vaccination infrastructure, with delivery mechanisms not yet well-established. Implementation: The public health and medical communities should educate providers about methods to implement and support hepatitis B vaccination services.

  • Lack of tracking systems. Implementation: Health departments were encouraged to implement adult immunization registries.

  • Lack of time and low priority for this vaccination is cited by providers, as well as limitations in providers’ ability to ascertain patient high risk behaviors. Implementation: Providers should be knowledgeable about hepatitis B and the need for vaccination. To educate them, the public health/medical communities should define the vaccination’s benefits. Implementation: use questionnaires or interviews by office staff to identify eligible persons and simplify the risk assessment, emphasizing risks for sexual transmission and percutaneous or mucosal blood exposures. If risk ascertainment is a barrier, alternative vaccination strategies can be used (for example, targeting age groups at highest risk).

  • Lack of awareness of the part of patients that they may need the vaccine, and fear of the stigma that comes from acknowledging risk behaviors. Implementation: Health departments and CBOs should increase awareness of the benefits of hepB vaccination, particularly among risk populations; providers should help patients assess their need for vaccination; acknowledgement of specific risk factor is not a requirement for vaccination.

  • Unclear fiscal/reimbursement assurances, perhaps most important. There are little data on reimbursement mechanisms and many patients have no vaccination insurance coverage.


The proposed recommendations were as follow:

  • Hepatitis B vaccination is recommended for all unvaccinated adults at risk for H.B.V. infection and all adults seeking protection from H.B.V. infection. Acknowledgement of a specific risk factor is not a requirement for vaccination.

  • Unvaccinated adults at risk for H.B.V. infection are those at risk for sexual transmission (sexual partners of H.B.s.A.g.-positive persons, sexually-active persons not in a long term, mutually monogamous relationship (for example, greater than 1 partner in the prior 6 months), persons evaluated/treated for S.T.D.s (including H.I.V.), men who have sex with men, those at risk for transmission by percutaneous or mucosal exposure to blood, and others (for example, international travelers and persons with chronic liver disease).”


Implementation recommendations were structured to take into account setting-specific vaccination strategies, to achieve high coverage among the persons for whom it is recommended.

  • Hepatitis B vaccination is recommended for all adults in: S.T.D. and H.I.V. treatment facilities, H.I.V. testing facilities, drug abuse treatment and prevention facilities, correctional facilities, health care settings serving M.S.M., chronic hemodialysis facilities and end-stage renal disease programs, and institutions and nonresidential daycare facilities for developmentally disabled persons. Implementation: Assume all unvaccinated adults are at risk; implement standing orders to administer hepatitis B vaccine to unvaccinated adults as part of routine services; provide hepatitis B vaccine as a component of S.T.D., H.I.V./AIDS, and other viral hepatitis prevention services; and when feasible, provide Hepatitis B in outreach settings.

  • In primary-care and specialty medical settings hepatitis B vaccination is recommended for: all unvaccinated adults at risk for H.B.V. infection and all adults seeking protection from H.B.V. infection. Acknowledgment of a specific risk factor is not a requirement for vaccination. Implementation: Providers should help patients assess their need for vaccination by obtaining their risk history and emphasizing sexual transmission and percutaneous or mucosal exposure to blood. If ascertainment of H.B.V. infection risk is a barrier, providers are encouraged to use other vaccination strategies, such as offering hepatitis B to all unvaccinated adults in the age groups of highest infection risk (that is, less than 45 years).



H.B.s.A.g. screening as a component of immunization services can identify of H.B.s.A.g. positive persons and allow the prevention of transmission to others by vaccinating at-risk contacts. This also could reduce the risk of chronic liver disease in infected persons by providing medical management and antiviral therapy. The management of H.B.s.A.g.-positive persons can enhance vaccination strategies to eliminate H.B.V. transmission. H.B.s.A.g. testing for chronic infection should be undertaken for:

  • All persons born in countries with H.B.s.A.g. prevalence greater than 2 percent (for example, countries of Asia and Africa with high prevalence, Pacific Islands).

  • Other persons who should be tested for H.B.s.A.g. in the context of immunization services include pregnant women, persons testing positive for anti-HBc before vaccination, and non-responders to vaccination.

  • Those who are determined to be H.B.s.A.g.-positive should receive appropriate medical management and their susceptible household, sexual, or needle-sharing contacts should be identified and vaccinated.

  • Those who are tested as H.B.s.A.g.-negative require no further management unless hepatitis B vaccine is recommended.


Summary:

  • Adult hepatitis B rates have declined by greater than 70 percent since 1990. This decline is expected to continue with aging of vaccinated cohorts of infants, children and adolescents

  • Elimination of H.B.V. transmission can be accelerated by increasing vaccination coverage among at-risk adults, since approximately 85 percent of cases occur among persons with risk characteristics

  • The recommendations provide setting-specific implementation strategies to achieve high vaccination coverage among at risk adults and recommendations to overcome barriers to vaccination.


Hepatitis B Working Group Discussions

Presenter: Dr. Tracy Lieu, Chair


There was some controversy among Working Group members about making the adult recommendations age-based and universal. Most did not support the potential addition of universal vaccination of those aged 19 to 25 years, although a few did or were undecided. A permissive universal vaccination “where feasible” had little support. However, all the Working Group members supported risk-targeted vaccination.


Risk-targeted strategy. The advantages of a risk-targeted strategy were that it:
1) targets those persons who comprise greater than 90 percent of those contracting hepatitis B, including approximately 40 percent of cases with no identified risk factor; 2) is consistent with existing recommendations for assessment of patient drug and sex behavior; 3) it reaches adults at risk in all age groups, 4) venues exist for program implementation, and 5) it is demonstrably feasible and cost-effective.

  • The disadvantages were that: 1) providers often do not inquire about behavioral risk factors, and 2) this approach does not reach all adults with no identified risk factors.


Universal vaccination. The potential addition of universal vaccination of 19 to 25 year-olds would essentially be a catch up strategy, since many of these would have been vaccinated against hepatitis B in the childhood schedule. The advantages of adding universal vaccination of 19 to 25 year-olds were that: 1) this could potentially reach more young adults, including those with no identified risk factor, 2) it could simplify vaccination decision making, 3) remove the stigma of having to disclose risk factors, and 4) spur the needed development of an infrastructure for adult vaccination.


However, the rationale against adding universal vaccination of 19 to 25 year-olds was that: 1) this would likely prevent few additional cases beyond risk-targeted vaccination; 2) greater than 90 percent of those contracting hepatitis B could be identified by a risk-targeted strategy; 3) the highest-risk persons may not seek primary care in these or any setting; 4) there was no evidence of feasibility to implement; 5) this approach would cost substantially more than risk-targeted vaccination; and 6) it may divert resources from risk-targeted efforts. This argument was found to be more compelling, particularly the last.


Three options were offered, with the first recommended by the Working Group:

  1. Risk-targeted strategy alone (recommended by Working Group).

  2. Risk-targeted strategy plus universal vaccination of 19 to 25 year-olds.

  3. Risk targeted strategy plus universal vaccination of 19 to 25 year-olds “when feasible.”


Discussion included:

  • Option A was supported by Drs. Morita and Gilsdorf as a better use of public health resources. They felt it premature to define the risk-based strategy as unsuccessful, as it has only been implemented for a few years. A universal recommendation would likely have less impact than a targeted one, and could divert limited resources from the highest risk groups.

  • Option B was supported by Dr. Allos, since greater than 50 percent of those with hepatitis B did not have the risk factor of more than one sexual partner in the last six months, and physicians most often screen M.S.M. and I.D.U.s. She also hoped for age-based recommendations to raise the flat reduction rates of the last six years. Option C was supported by Dr. Marcuse in order to convey clearly that universal hepatitis B vaccination of adults is desirable, although the A.C.I.P. should clarify its recommendation to “where feasible” as due to resource issues. Drs. Temte and Middleman agreed, since practices are already overloaded, addressing at least three problems per patient, and the clinics catering to the highest risk groups are chaotic and under funded. The risk-based strategy has not worked in the past among adolescents, who are fertile and also at highest risk (and uncomfortable disclosing it). Dr. Middleman suggested consideration of using an immunization platform for those aged 14 to 21, building on growing influenza vaccination interest and the imminent Tdap vaccine release. Dr. Tan expressed the A.M.A.’s support of that, but if not done, they would support universal vaccination.


Identified challenges to the ultimate eradication of hepatitis B included:

  • The need for additional strategies to achieve administration of the second and third doses for a full vaccination series. Providers are currently advised to track doses and use reminder systems to accomplish that. Immunization registries will also help.

  • One unaddressed failure of the risk-based strategy is the lack of funding to implement adult vaccination, something N.I.P. has struggled to fund for greater than 20 years. C.D.C. leadership has highly prioritized and planned an initiative to target risk groups, but has no funding as yet to do so. C.D.C. and other immunization partners need to state this as a problem.


Challenges to a universal recommendation were listed:

  • It may not be feasible to know who has been vaccinated if an age-based system is used. Most parents do not know their children’s vaccination schedule and many cannot produce records. Without the latter, vaccination of the entire cohort may be required.

  • Physicians’ safety net is already stretched thin. Being deprived of some “wiggle room” would leave them open to liability risk.

  • A universal H.B.V. vaccination may divert health departments’ limited vaccine supplies from the targeted groups.


Models. The A.C.H.A. has successfully produced a 65 percent to 66 percent uptake among college graduates. College health services should be added to the list of facilities proving vaccination services to all adults. Correctional facilities’ inmates are vaccinated in six or seven states, with an 80 percent to 85 percent acceptance and high third dose coverage.


Dr. Deborah Wexler, of the Immunization Action Coalition (I.A.C.) expressed their opinion that this recommendation is too complicated. She recommended a review of its feasibility by family physicians, health departments, internists and obstetricians. Risk-based vaccination historically has been difficult to implement. The I.A.C. suggested, at a minimum, a catch-up program so that 18 to 25 year-olds would automatically be screened upon visiting their physician. The recommendation also did not address the disproportionately high rate of hepatitis B in African-Americans.


Dr. Tan noted the A.C.I.P. recommendations’ weight with providers and insurance carriers. If A.C.I.P. offers encouragement rather than a recommendation of the vaccination, it likely will not be covered or well implemented.


PUBLIC COMMENT

Dr. Joel Engardio, of Stanford University’s Asian Liver Center, spoke as a patient advocate. There is chronic infection in older Americans, but his late partner, Dr. Mark Lin, was diagnosed with terminal liver cancer caused by chronic hepatitis B at only age 30. He was a non-drinker and did not use drugs. He was Asian-American; his mother was born in China. Hepatitis is the “silent killer of Asian-Americans” and one in ten are unaware of their chronic hepatitis B infection. Even Dr. Lin did not know the risk. Particularly in areas like San Francisco with large Asian populations, education about this epidemic is needed. The vaccine is simple to use, effective and available, and vaccination should be promoted.


Dr. Samuel So, of the USC Cancer Center, thought this issue important enough that he canceled his clinic hours to attend this meeting. The greatest health disparity between Americans and Asians is the prevalence of hepatitis B. Most physicians do not know about Asians’ 25 percent chance of dying from the sequelae of chronic hepatitis B infection. A vaccine has been available for the last 20 years that could prevent 80 percent of liver cancer in Asians, but their five-year survival rate is less than 10 percent. Testing to identify those chronically infected is also important because new antivirals can reduce the risk of liver cirrhosis and cancer. The A.C.I.P. recommendations have a great impact on choices made by physicians and health care plans. Dr. So urged A.C.I.P. to name Asian-Americans as a high risk group and to recommend H.B.s.A.g. testing of children and adults, appropriate treatment of those testing positive, and testing/vaccination of all their family members and partners. He additionally requested a section to address the need to educate health care providers about the importance of addressing this disease among Asian-Americans.


Ms. Marie Bresnahan is the vice president of programs for the American Liver Foundation and a member of the National Viral Hepatitis Roundtable, which comprises greater than 100 member organizations. Viral hepatitis patients have joined the Roundtable and have written a national strategy to eliminate hepatitis B. Because current strategies do not identify or reach those at risk and needing vaccination, the NVHR hoped the A.C.I.P. recommendations would be expanded. The ALF is also developing their policy statement. They asked to be involved in the process.


The proposed recommendation was risk targeted vaccination with an implementation recommendation to offer vaccination to all adults in selected settings, including S.T.D. clinics, drug-abuse treatment facilities, H.I.V.-testing sites, and correctional facilities. Primary care and specialty medical care settings should offer hepatitis B vaccine to adults in high-risk groups. If risk ascertainment is a barrier in primary care and specialty medical settings, alternative vaccination strategies can be used (for example, targeting age groups at highest risk). More discussion of screening for H.B.s.A.g. surface antigen status and the related criteria was requested. With new treatments, the benefits of screening are becoming more clear and further guidance will be needed.


Dr. Abramson conducted a straw poll of the committee members on the three options: Option A: Beck, Campbell, Finger, Gilsdorf, Hall, Lieu, Morita, Abramson

Option B: Allos

Option C: Marcuse, Womeodu


Dr. Lieu moved to adopt Option A as the A.C.I.P.’s recommendation. Dr. Marcuse seconded the motion.

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