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Hep Express Issue

Issue Number 37, November 4, 2005
 
Contents of this Issue
1. ACIP recommends hepatitis A vaccine for all children
2. FDA approves Havrix hepatitis A vaccine for use in children as young as age 12 months
3. New: CDC issues Adult Immunization Schedule for October 2005–September 2006
4. CDC adds web section on viral hepatitis transmission in ambulatory care settings
5. Detailed agenda for National Viral Hepatitis Prevention Conference available online
6. CDC discontinuing online hepatitis C training module
7. MMWR notifies readers about FDA's approval of VAQTA hepatitis A vaccine for children 1 year and older
8. The October 2005 issue of Vaccinate Adults is in the mail and on the Web
9. Updated: IAC revises two professional-education pieces related to viral hepatitis
10. National blood-borne pathogen conference to be held October 2006 in Chicago; abstracts due November 18
11. B Informed Patient Conference notes posted

ABBREVIATIONS: ACIP, Advisory Committee on Immunization Practices; CDC, Centers for Disease Control and Prevention; DVH, Division of Viral Hepatitis; HAV, hepatitis A virus; HBV, hepatitis B virus; HCV, hepatitis C virus; IAC, Immunization Action Coalition; IDU, injection drug user; MMWR, Morbidity and Mortality Weekly Report; MSM, men who have sex with men; STD, sexually transmitted disease; VIS, Vaccine Information Statement; WHO, World Health Organization.
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November 4, 2005
ACIP RECOMMENDS HEPATITIS A VACCINE FOR ALL CHILDREN

[The following is cross posted from the Immunization Action Coalition's "IAC EXPRESS" electronic newsletter, 10/31/05.]

At the October 26-27 ACIP meeting, ACIP members voted that all children be vaccinated against hepatitis A virus infection. On October 28, CDC issued a press release announcing the decision. Portions of the press release are reprinted below.

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For immediate release
October 28, 2005

CDC'S ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES EXPANDS HEPATITIS A VACCINATION FOR CHILDREN; the recommendation for vaccination of children between 1-2 years of age will be integrated into the routine childhood vaccination schedule

An advisory committee to the Centers for Disease Control and Prevention (CDC) has recommended that all children in the United States receive hepatitis A vaccine. The previous recommendation of the Advisory Committee on Immunization Practices (ACIP), in 1999, called for vaccinations in states with the highest rates of hepatitis A.

About two-thirds of cases are now reported from states in which hepatitis A vaccination of children was not recommended. The ACIP recommendation is for children to receive the first dose of a two-dose series of hepatitis A vaccine between 1 and 2 years of age and that the vaccine be integrated into the routine childhood vaccination schedule. . . .

"Routine vaccination of children is the most effective way to reduce the incidence of hepatitis A," said Dr. Steve Cochi, acting director of CDC's National Immunization Program. "This recommendation is an important step toward the total elimination of the transmission of hepatitis A virus in the United States. . . ."

In 1999, the ACIP recommended routine hepatitis A vaccination for children living in 11 states with the highest rates of hepatitis A. During the period before vaccine was available, the average incidence of hepatitis A in these states (Alaska, Arizona, California, Idaho, Nevada, New Mexico, Oklahoma, Oregon, South Dakota, Utah, and Washington) had been at least 20 cases per 100,000 people, about twice the national average. In 1999, the ACIP also recommended that vaccination be considered in an additional six states (Arkansas, Colorado, Missouri, Montana, Texas, and Wyoming) where the average incidence had been at least 10 but less than 20 cases per 100,000 people. During the period before vaccine was available, each year about two-thirds of all hepatitis A cases nationwide were reported in these 17 states.

The ACIP continues to recommend hepatitis A vaccination for travelers to countries with a high prevalence of hepatitis A, men who have sex with men, illegal drug users, and persons with chronic liver disease.

Recommendations of the ACIP become recommendations of CDC once they are accepted by the director of CDC and the Secretary of Health and Human Services and are published in the Morbidity and Mortality Weekly Report.

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To read the press release online, go to:
http://www.cdc.gov/od/oc/media/pressrel/r051028.htm
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November 4, 2005
FDA APPROVES HAVRIX HEPATITIS A VACCINE FOR USE IN CHILDREN AS YOUNG AS AGE 12 MONTHS

[The following is cross posted from the Immunization Action Coalition's "IAC EXPRESS" electronic newsletter, 10/24/05.]

On October 17, FDA approved the use of GlaxoSmithKline's Havrix hepatitis A vaccine for persons ages 12 months and older. In the original licensure, the age indication was for persons ages two years and older.

To view the supplemental license approval information on the FDA website, go to:
http://www.fda.gov/cber/products/havgsk101705.htm

To read the prescribing information, go to:
http://www.fda.gov/cber/label/havgsk101705LB.pdf
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November 4, 2005
NEW: CDC ISSUES ADULT IMMUNIZATION SCHEDULE FOR OCTOBER 2005–SEPTEMBER 2006

[The following is cross posted from the Immunization Action Coalition's "IAC EXPRESS" electronic newsletter, 10/17/05.]

CDC published "Recommended Adult Immunization Schedule--United States, October 2005–September 2006" as an MMWR QuickGuide in the October 14 issue of MMWR. The article is reprinted below in its entirety, excluding references and two figures.

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Changes in the Schedule for October 2005-September 2006

The 2005–2006 schedule differs from the previous schedule as follows:

  • Vaccines listed on the age-based schedule (Figure 1) are displayed so that vaccines recommended for routine use can be differentiated from those recommended for adults with certain risk indicators (similar to the childhood immunization schedule). This is illustrated both by the color scheme and by the broken line.
     
  • The yellow bars ("For all persons in this group") and the green bars ("For persons lacking documentation of vaccination or evidence of disease") from the previous schedule have been merged into one yellow bar, which now reads, "For all persons in this category who meet the age requirements and who lack evidence of immunity (e.g., lack documentation of vaccination or have no evidence of prior infection)."
     
  • The purple bar has been changed from "For persons at risk (e.g., with medical/exposure indications)" to "Recommended if some other risk factor is present (e.g., on the basis of medical, occupational, lifestyle, or other indications)." The purple bar was added to the 50–64 years and >=65 years age-group columns for measles, mumps, rubella (MMR) vaccine.
     
  • The column, "Diabetes, heart disease, chronic pulmonary disease, or chronic liver disease including chronic alcoholism" has been transposed with the column, "Congenital immunodeficiency, leukemia, lymphoma, generalized malignancy, therapy with alkylating agents, antimetabolites, cerebrospinal fluid leaks, radiation, or large amounts of corticosteroids" on the medical/other indications schedule (Figure 2) so that contraindications for MMR and varicella vaccines are now side-by-side.
     
  • The row for varicella vaccine has been moved up on both figures (i.e., to immediately after MMR vaccine) because the vaccine is now universally recommended for certain age groups.
     
  • Meningococcal vaccine has been added to the medical/other indications schedule (Figure 2). The footnote has been revised to incorporate the recently published ACIP recommendations for this vaccine.
     
  • The tetanus and diphtheria footnote (#1) has been reworded.
     
  • The varicella footnote (#3) has been reworded in accordance with ACIP recommendations adopted in June 2005.
     
  • The influenza footnote (#4) has been revised to add the newest high-risk condition: neuromuscular conditions that compromise respiratory function.
     
  • A 10th footnote has been added regarding Haemophilus influenzae type b vaccination for populations at high risk (i.e., persons with asplenia, leukemia, and human immunodeficiency virus [HIV] infection).

The Adult Immunization Schedule is available in English at http://www.cdc.gov/nip/recs/adult-schedule.htm [IAC Express editor's note: The Spanish-language version will be available at a later date.] General information about adult immunization, including recommendations concerning vaccination of persons with HIV and other immunosuppressive conditions, is available from state and local health departments and from the National Immunization Program at http://www.cdc.gov/nip Vaccine information statements are available at http://www.cdc.gov/nip/publications/vis ACIP statements for each recommended vaccine can be viewed, downloaded, and printed from the National Immunization Program website at http://www.cdc.gov/nip/publications/acip-list.htm Instructions for reporting adverse events to the Vaccine Adverse Event Reporting System are available at http://www.vaers.hhs.gov or by telephone, (800) 822-7967.

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To access a web-text (HTML) version of the Adult Immunization Schedule, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5440-Immunizationa1.htm

To access a ready-to-print (PDF) version of it, go to:
http://www.cdc.gov/mmwr/PDF/wk/mm5440-Immunization.pdf

To receive a FREE electronic subscription to MMWR (which includes new ACIP statements), go to:
http://www.cdc.gov/mmwr/mmwrsubscribe.html
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November 4, 2005
CDC ADDS WEB SECTION ON VIRAL HEPATITIS TRANSMISSION IN AMBULATORY CARE SETTINGS

CDC's Division of Viral Hepatitis has created a new web section titled "Viral Hepatitis Transmission in Ambulatory Health Care Settings."

The introduction states: "The delivery of health care has the potential to transmit hepatitis B virus (HBV) and hepatitis C virus (HCV) to both healthcare workers (HCWs) and patients. Recently, four large outbreaks of HBV and HCV infections occurred in the United States among patients in ambulatory care facilities. All four outbreaks could have been prevented by adherence to basic principles of aseptic technique for the preparation and administration of parenteral medications. If you are a HCW involved in direct patient care, you must adhere to standard precautions and follow fundamental infection control principles, including safe injection practices and appropriate aseptic techniques."

Topics include injection safety, patient care equipment, work environment, hand hygiene and gloves, and administrative policy. Following the recommended infection control and safe injection practices should prevent patient-to-patient transmission of bloodborne pathogens, including HBV and HCV.

To access this new resource, go to:
http://www.cdc.gov/ncidod/diseases/hepatitis/spotlights/ambulatory.htm
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November 4, 2005
DETAILED AGENDA FOR NATIONAL VIRAL HEPATITIS PREVENTION CONFERENCE AVAILABLE ONLINE

A more detailed agenda for the National Viral Hepatitis Prevention Conference is now available online. Go to the conference website at http://www.nvhpc.com and click on "Conference Agenda." The document is in Microsoft Word format.

The conference is sponsored by CDC's Division of Viral Hepatitis, and will take place December 5–9, 2005, in Washington, DC.
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November 4, 2005
CDC DISCONTINUING ONLINE HEPATITIS C TRAINING MODULE

CDC's Division of Viral Hepatitis (DVH) is discontinuing the online hepatitis C module titled "Hepatitis C: What Clinicians and Other Health Professionals Need to Know."

To provide more current training on viral hepatitis, DVH has issued a cooperative agreement to the Seattle STD/HIV Prevention and Training Center of the University of Washington to develop a comprehensive online, interactive case-based training system. This training tool will cover core content in viral hepatitis, and will be available by early 2006. The DVH website (http://www.cdc.gov/hepatitis) will link to the new training curriculum when it becomes available.
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November 4, 2005
MMWR NOTIFIES READERS ABOUT FDA'S APPROVAL OF VAQTA HEPATITIS A VACCINE FOR CHILDREN 1 YEAR AND OLDER

[The following is cross posted from the Immunization Action Coalition's "IAC EXPRESS" electronic newsletter, 10/17/05.]

CDC published "Notice to Readers: FDA Approval of VAQTA (Hepatitis A Vaccine, Inactivated) for Children Aged [1 Year and Older]" in the October 14 issue of MMWR. The article is reprinted below in its entirety, with the exception of references.

***********************

On August 11, 2005, the Food and Drug Administration (FDA) approved an application of a pediatric/adolescent formulation of VAQTA (hepatitis A vaccine, inactivated) (Merck & Co., Whitehouse Station, New Jersey) for use among persons aged 12 months-18 years. Previously, the pediatric/adolescent formulation of VAQTA was approved for use in persons aged 2-18 years. The approved labeling change applies only to VAQTA and not to other licensed hepatitis A vaccines.

The formulation, dosage, and schedule for VAQTA have not changed. Each 0.5 mL dose of the pediatric/adolescent formulation of VAQTA contains approximately 25 units of formalin-inactivated hepatitis A virus antigen, adsorbed onto aluminum hydroxyphosphate sulfate, in 0.9% sodium chloride. The formulation does not contain a preservative.

VAQTA is now indicated for active immunization of persons aged 12 months [and older] to protect against disease caused by hepatitis A virus. The primary vaccination schedule is unchanged and consists of 2 doses, administered on a 0, 6-18 month schedule. The Advisory Committee on Immunization Practices (ACIP) has issued recommendations for hepatitis A vaccination.

Results from the study to lower the age indication for VAQTA indicated that 100% of 343 initially seronegative children aged 12-23 months who received 2 doses of VAQTA had seroconverted to antibody levels previously indicated to be protective. The study also indicated that VAQTA may be administered concomitantly with M-M-R II (measles, mumps, and rubella virus vaccine live). Insufficient data are available to evaluate the concomitant use of VAQTA with other routinely recommended childhood vaccines. According to the general recommendations of ACIP, inactivated vaccines generally do not interfere with the immune response to other inactivated or live vaccines.

In combined clinical trials reported as part of the labeling change application, 706 healthy children aged 12-23 months received 1 [or more] doses of VAQTA alone or in combination with other routinely recommended pediatric vaccines. The most commonly reported complaints after 1 or both doses of VAQTA were similar to those reported among older children. VAQTA is contraindicated in persons with known hypersensitivity to any component of the vaccine.

Additional information is available from the manufacturer's package insert and at telephone (800) 672-6372.

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To access a web-text (HTML) version of the complete article, go to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5440a7.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5440.pdf
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November 4, 2005
THE OCTOBER 2005 ISSUE OF VACCINATE ADULTS IS IN THE MAIL AND ON THE WEB

IAC recently mailed the latest issue of Vaccinate Adults (October 2005) to 130,000 adult medicine specialists and others who work in the field of immunization. Packed with immunization resources for health professionals and patients, the 12-page issue is well worth downloading. All articles and education pieces, except editorials, have been thoroughly reviewed by immunization and hepatitis experts at CDC.

HOW TO READ VACCINATE ADULTS ON THE WEB
You can view selected articles from the table of contents below or download the entire issue from the Web.

To view the table of contents with links to individual articles, go to: http://www.immunize.org/va

The PDF file of the entire issue, linked below, is 563,483 bytes. For tips on downloading and printing PDF files, go to: http://www.immunize.org/nslt.d/tips.htm

To download a ready-to-print (PDF) version of the October issue, go to: http://www.immunize.org/va/va16.pdf
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UPDATED: IAC REVISES TWO PROFESSIONAL-EDUCATION PIECES RELATED TO VIRAL HEPATITIS

The Immunization Action Coalition (IAC) has revised "Hepatitis A & B Vaccines. . . Be sure your patient gets the correct dose!" to reflect that FDA recently approved use of both hepatitis A vaccines in children as young as 12 months.

To obtain the document in ready-to-print (PDF) format, go to: http://www.immunize.org/catg.d/2081ab.pdf

To obtain it in web-text (HTML) format, go to: http://www.immunize.org/catg.d/2081ab.htm

Coleman I. Smith, MD, has updated a piece he wrote for IAC titled "Does your patient have chronic hepatitis B?" This piece answers questions often asked by physicians, and was revised to reflect newly licensed treatments.

To obtain the document in ready-to-print (PDF) format, go to: http://www.immunize.org/catg.d/p2162.pdf

To obtain it in web-text (HTML) format, go to http://www.immunize.org/nslt.d/n18/p2162.htm
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November 4, 2005
NATIONAL BLOOD-BORNE PATHOGEN CONFERENCE TO BE HELD OCTOBER 2006 IN CHICAGO; ABSTRACTS DUE NOVEMBER 18

The Community Health Center Foundation of Ohio and the American Liver Foundation will be presenting a conference about hepatitis C, HIV, and other blood-borne pathogens on October 26 and 27, 2006, in Chicago, IL.

"Blood Borne: A Silent Epidemic" will present the best practices in treatment, research, and patient empowerment from throughout the nation.

Abstracts are due by November 18, 2005. Go to http://www.commhealthcenter.org for information about abstract submission, conference agenda, and registration. You can also call(330) 315-3710, or email rachel.fox@commhealthcenter.org
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November 4, 2005
B INFORMED PATIENT CONFERENCE NOTES POSTED

The notes of the Hepatitis B Foundation's (HBF) 5th annual B Informed Patient Conference have been posted on the HBF website at http://www.hepb.org/patients/patient_conference2005.htm


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