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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
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
Hepatitis B Vaccine Recommendations for Adults
Hepatitis B Working Group Discussions
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
Recommendations for Hepatitis A Vaccination of Children
Working Group Discussions/Economic Analyses
V.F.C. Resolution Vote
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
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
OCTOBER 27, 2005
V.F.C. VOTE ON HEPATITIS A VACCINE
UNIVERSAL INFLUENZA VACCINATION
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
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 Resistance to Antiviral Drugs
AVIAN INFLUENZA H5N1
Update on H5N1
Update on H5N1 Vaccine Clinical Trial
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).
A.C.I.P. Executive Secretary Dr. Larry Pickering made several announcements:
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.
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 proposed recommendations were as follow:
Implementation recommendations were structured to take into account setting-specific vaccination strategies, to achieve high coverage among the persons for whom it is recommended.
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:
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.
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:
Identified challenges to the ultimate eradication of hepatitis B included:
Challenges to a universal recommendation were listed:
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.
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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