Issue Number
275 September
26, 2001
CONTENTS OF THIS ISSUE
- MMWR notifies readers of FDA-licensed hepatitis A and B
combination vaccine
- CDC educates parents and providers about reinstating the
birth dose of hepatitis B vaccine
- Get your campaign kit for National Adult Immunization
Awareness Week October 14-20
- Fifth edition of NCAI's "Resource Guide for Adult and
Adolescent Immunization" released
- "Communicating with Patients about Immunization" updates
from NNII ready to download
- Teleclinic on Tetanus Prophylaxis and Wound Management
rescheduled for October
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September 26, 2001
MMWR NOTIFIES READERS OF FDA-LICENSED HEPATITIS A AND B
COMBINATION VACCINE
The Centers for Disease Control and Prevention (CDC) published a Notice to Readers titled "FDA Approval for a
Combined Hepatitis A and B Vaccine" in the September 21, 2001, issue of the Morbidity and Mortality Weekly Report
(MMWR). The entire notice, excluding the three footnote references, reads as
follows:
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On May 11, 2001, the Food and Drug Administration (FDA) licensed a combined hepatitis A and B vaccine (Twinrix
[registered trademark]) for use in persons aged 18 years and older. Twinrix is manufactured and distributed by
GlaxoSmithKline Biologicals (Rixensart, Belgium), and is made of the antigenic
components used in Havrix and Engerix-B (GlaxoSmithKline). The antigenic components in
Twinrix have been used routinely in separate single antigen vaccines in the United States since 1995 and 1989 as
hepatitis A and B vaccines, respectively.
Vaccine Description
Each dose of Twinrix contains at least 720 enzyme-linked immunosorbent assays units of inactivated hepatitis A virus
and 20 mcg of recombinant hepatitis B surface antigen (HBsAg) protein, with 0.45 mg of aluminum in the
form of aluminum hydroxide and aluminum phosphate as adjuvants, 5.0 mg 2-phenoxyethanol as a preservative, and pH stabilizer in
normal saline. Trace amounts of thimerosal (<1 æg mercury), neomycin (less than or equal to 20
ng), formalin (less than or equal to 0.1 mg), and yeast protein (less than or
equal to 5%) also are present from the manufacturing process.
Indications and Usage
Twinrix is indicated for vaccination of persons aged 18 years or older against
hepatitis A and B. Any person in this age group having an indication for both
hepatitis A and B vaccination can be administered Twinrix, including patients
with chronic liver disease, users of illicit injectable drugs, men who have sex
with men, and persons with clotting factor disorders who receive therapeutic
blood products. For international travel, hepatitis A vaccine is recommended
for travelers to areas of high or intermediate hepatitis A endemicity; hepatitis
B vaccine is recommended for travelers to areas of high or intermediate hepatitis B endemicity who plan to stay for 6 months or
longer and have frequent close contact with the local population. Primary vaccination consists
of three doses, given on a 0-, 1-, and 6-month schedule, the same schedule as that used for single antigen hepatitis B vaccine.
Safety and Immunogenicity
Adverse experiences (AEs) were evaluated in clinical trials in which 6594 doses of Twinrix were administered to 2165
persons. Observed AEs generally were similar in type and frequency to those observed after vaccination with
monovalent hepatitis A and B vaccines. The frequency of AEs did not increase with subsequent doses of Twinrix. No
serious vaccine-related AEs were observed (GlaxoSmithKline Biologicals, unpublished data, 2001). Twinrix
is contraindicated in persons with known hypersensitivity to any component of
the vaccine.
Prelicensure clinical trials indicate that the immunogenicity of Twinrix is equivalent to that of the
single antigen hepatitis vaccines. Data from 11 clinical trials that included adults aged 17-70 years indicated, 1
month after completion of the three dose series, seroconversion for antibodies against
hepatitis A virus (anti-HAV titer greater than or equal to 20 mIU/mL or
33mIU/mL [Enzymun-Test, Boehringer Mannheim Immunodiagnostics, Mannheim, Germany]) were elicited in
99.9% of vaccinees, and protective antibodies against HBsAg (anti-HBs greater than or equal to 10 mIU/mL
[AUSAB, Abbott Laboratories, Abbott Park, Illinois]) were elicited in 98.5% of
vaccinees. One month after one dose of Twinrix, seroconversion to anti-HAV was seen in 93.8% of vaccinees
and protective anti-HBs concentrations in 30.8%. One month after the second dose, seroconversion to anti-HAV was
seen in 98.8% of vaccinees, and protective anti-HBs concentrations in 78.2%.
The efficacy of Twinrix is expected to be comparable with existing single antigen
hepatitis vaccines. The persistence of anti-HAV and anti-HBs following
Twinrix administration is similar to that following single antigen hepatitis A and
B vaccine administration at 4 years follow-up (GlaxoSmithKline Biologicals, unpublished data, 2001). Additional
information is available from the manufacturer's package insert and GlaxoSmithKline Vaccines, telephone
(800) 366-8900.
To view or print the MMWR notice with references, go to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5037a4.htm
To obtain a camera-ready (PDF format) copy of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5037.pdf
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September 26, 2001
CDC EDUCATES PARENTS AND PROVIDERS ABOUT REINSTATING THE BIRTH DOSE OF HEPATITIS B VACCINE
CDC provides information online for both the public and health professionals
about the importance of providing hepatitis B vaccinations at birth prior to
hospital discharge.
For parents, CDC summarizes the rationale and importance of giving the first
hepatitis B vaccine dose at birth prior to hospital discharge. To view CDC's
parent education piece, "Get Your Baby the First Dose at Birth," go to: http://www.cdc.gov/ncidod/diseases/hepatitis/spotlights/birth_dose.htm
For health professionals, CDC has placed online two
PowerPoint presentations. The first is "Hepatitis B and You," which is designed for use in
educating women who test positive for the hepatitis B virus during pregnancy.
To view or print the presentation, go to: http://www.cdc.gov/ncidod/diseases/hepatitis/b/education/index.htm
The second is "Back to Basics: The Challenge of Reinstating Hepatitis B Vaccination at Birth," which emphasizes the
following points: (1) the availability of hepatitis B vaccines that do not contain thimerosal as a
preservative; (2) the rationale and importance of resuming the routine hospital
birth dose of hepatitis B vaccine for all infants; and (3) the importance of
screening all pregnant women for hepatitis B surface antigen (HBsAg). The faculty team that
created "Back to Basics" was headed by Philip Rosenthal, MD, Director of Pediatric Hepatology and Medical Director
of the Pediatric Liver Transplant Program at the University of California, San Francisco
Medical Center, San Francisco, CA. To view or print the presentation, go to:
http://www.cdc.gov/ncidod/diseases/hepatitis/b/basics/index.htm
For more viral hepatitis information, visit CDC's Division of Viral Hepatitis
website at: http://www.cdc.gov/hepatitis
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September 26, 2001
GET YOUR CAMPAIGN KIT FOR NATIONAL ADULT IMMUNIZATION AWARENESS WEEK OCTOBER 14-20
The National Coalition for Adult Immunization (NCAI), the National Foundation
for Infectious Diseases, and the National Partnership for Immunization have spearheaded this
annual event. This year's National Adult Immunization Awareness Week (NAIAW) theme is "Prevention for a Healthy
Future."
NAIAW's campaign kit offers updated fact sheets on adult and adolescent immunization and on vaccine-preventable
diseases along with many more materials and resources that will assist in promoting adult and adolescent
immunization. Organizations are encouraged to duplicate the materials included in the kit. All of the pages are perforated for
easy removal and duplication.
The cost is $10.00 per kit (prepaid only, shipping/handling included).
To order, mail payment to:
National Foundation for Infectious Diseases
4733 Bethesda Avenue, Suite 750
Bethesda, MD 20814-5228
Make checks payable to the National Foundation for
Infectious Diseases.
To download and print an order form at the NCAI website, go to: http://www.nfid.org/ncai/publications/naiaw-kit/
To contact NCAI, call (301) 656-0003, fax (301) 907-0878, or email ncai@nfid.org
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September 26, 2001
FIFTH EDITION OF NCAI's RESOURCE GUIDE FOR ADULT AND ADOLESCENT IMMUNIZATION RELEASED
The newly released "Resource Guide for Adult and Adolescent Immunization," 5th edition, is a catalog listing hundreds
of resource materials that address the broad issue of adult and adolescent immunization with emphasis on the 10
major vaccine-preventable diseases: diphtheria, hepatitis A and B, influenza,
measles, mumps, pneumococcal disease, rubella, tetanus, and varicella. Materials listed include
slides, videotapes, brochures, pamphlets, newsletters, posters, reports, teaching materials, and other promotional
tools.
This guide is available for $20.00 each (prepaid only, shipping/handling included) for one or two copies and
$17.00 each (prepaid only, shipping/handling included) for three or more copies.
To order, mail payment to:
National Foundation for Infectious Diseases
4733 Bethesda Avenue, Suite 750
Bethesda, MD 20814-5228
Make checks payable to the National Foundation for
Infectious Diseases.
To download and print an order form at the NCAI website, go to: http://secure.bnt.com/webresponse/nfid/guide01/
To contact NCAI, call (301) 656-0003, fax (301) 907-0878, or email ncai@nfid.org
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September 26, 2001
"COMMUNICATING WITH PATIENTS ABOUT IMMUNIZATION" UPDATES FROM NNII READY TO DOWNLOAD
Need to add the National Network for Immunization Information (NNII) resource, "Communicating with Patients
about Immunization," to your library? NNII's kit is the result of extensive research with parents, physicians,
nurses, immunization experts, and risk communication specialists. The 3-ring binder
contains over 100 pages of immunization materials that may be used as handouts. The
cost is $20. For more information call (877) 341-6644 or order online at: http://www.immunizationinfo.org
NNII recently has updated this resource kit for clinicians who already have it.
Updated resource pages can be downloaded free from the website. Follow this link to print
replacement pages in the orange section "Additional Resources" under the "Internet and Hotline Resources for
More Information" tab: http://www.immunizationinfo.org/PDFs/6_IREC.pdf
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September 26, 2001
TELECLINIC ON TETANUS PROPHYLAXIS AND WOUND MANAGEMENT RESCHEDULED FOR OCTOBER
The teleclinic "Tetanus Prophylaxis and Wound Management" has been rescheduled for the following two dates in
October:
- Monday, October 8, at 5:00 p.m. EDT
- Tuesday, October 9, at 7:00 p.m. EDT
The featured speaker is David Talan, MD, FACEP, FIDSA, from
the UCLA School of Medicine in Los Angeles, and the moderator is Erwin W. Gelfand,
MD, from the University of Colorado Health Sciences Center in Denver.
To preregister and receive materials for this program, please call Interactive
Communications at (800) 870-8376, or visit: http://www.interactiveteleclinics.com/teleclinic_2.shtml
For information about receiving Continuing Medical Education (CME) Credit or Nursing Contact Hours for this
teleclinic, go to: http://www.interactiveteleclinics.com/review/review_tc2.shtml
RealPlayer must be installed to view this teleclinic.
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