Immunization Action Coalition and the Hepatitis B Coalition

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Issue Number 401            July 28, 2003

CONTENTS OF THIS ISSUE

  1. New: National Immunization Program publishes "Influenza Vaccine Bulletin #2" for influenza season 2003-04
  2. New: July issue of "Immunization Works!" electronic newsletter available online
  3. FDA approves supplement to Infanrix license, allowing providers to give it as a fifth consecutive DTaP dose
  4. JAMA article links autism to accelerated brain growth in the first year of life
  5. IAC continually updates its web page on the hepatitis B vaccine birth dose
  6. New: Children's Vaccine Program at PATH posts free vaccine advocacy tools online
  7. CDC reports on polio eradication efforts in Afghanistan and Pakistan

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July 28, 2003
NEW: NATIONAL IMMUNIZATION PROGRAM PUBLISHES "INFLUENZA VACCINE BULLETIN #2" FOR INFLUENZA SEASON 2003-04

On July 22, the National Immunization Program of the Centers for Diseases Control and Prevention (CDC) issued "Influenza Bulletin #2." It is reprinted below in its entirety.

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INFLUENZA VACCINE BULLETIN #2
Influenza Season 2003-04
July 22, 2003

The National Immunization Program (NIP) of the Centers for Disease Control and Prevention (CDC) publishes and distributes periodic bulletins to update partners about recent developments related to the  production, distribution, and administration of influenza vaccine. All recipients of this bulletin are encouraged to distribute each issue widely to colleagues, members and constituents.


INFLUENZA VACCINE SUPPLY AND PRODUCTION

The FDA approves FluMist

On June 17, 2003, the Food and Drug Administration (FDA) issued a license to MedImmune Inc. to produce FluMist, a live attenuated influenza vaccine administered intranasally. To view the package insert for this product, go to http://www.fda.gov/cber/label/inflmed061703LB.pdf

The Advisory Committee on Immunization Practices (ACIP) will publish recommendations for this new vaccine in the Morbidity and Mortality Weekly Report (MMWR) before the 2003-04 influenza vaccination season begins.

For other information on the approval of FluMist, go to
http://www.cdc.gov/nip/Flu/News.htm#flumist

Updated Projection for This Year's Influenza Vaccine Supply

The three influenza vaccine manufacturers licensed to produce for the U.S. market, Aventis Pasteur, Powderject Vaccines (which produces the Evans Vaccines brand), and MedImmune, project an aggregate  total of 86.5-93 million doses for 2003. This recent projection remains from 2 to 8.5 million doses below last  year's total production, yet still exceeds the estimated 79 million doses that were sold to end-users in 2002.

The AMA strongly supports influenza vaccination efforts

In a recent article published in the AMA/Federation News, AMA Executive Vice President and CEO Michael D. Maves, MD, affirmed the AMA's position on influenza vaccination. While addressing attendees at the  National Influenza Vaccine Summit in Chicago on May 20, 2003, he said, "We are committed to working with all of you to support mechanisms to increase influenza vaccine supply and vaccine demand among physicians, other providers and the public to reach the goals of Healthy People 2010."

Review the entire article for additional highlights at
http://www.ama-assn.org/ama/pub/article/2403-7702.html

INFLUENZA VACCINE DISTRIBUTION AND ADMINISTRATION

Possible relaxation of ACIP's tiered approach to vaccination this season

On June 18, the ACIP voted to relax the tiered approach to vaccination if, by late summer, vaccine production is proceeding satisfactorily.

If the National Immunization Program (NIP), in consultation with the FDA and the influenza vaccine manufacturer, decide to relax the tiered approach it made for 2003, an announcement will be published in the MMWR and in a subsequent issue of this bulletin. The CDC and FDA staff will collaborate to draft a  process by which such decisions can be made each year.

The VFC Program expands to cover influenza vaccine

The ACIP continues to encourage influenza vaccination for children 6-23 months and for household contacts and out-of-home caregivers of children under 2 years. The Vaccines For Children (VFC) Program has expanded to cover VFC-eligible children in these groups during the 2003-2004 season.

   INFLUENZA VACCINE COMMUNICATIONS AND RESOURCES

The Vaccine Information Statement for inactivated influenza vaccine is located at
http://www.cdc.gov/nip/publications/VIS/vis-flu.pdf

A separate Vaccine Information Statement for FluMist vaccine will be distributed and posted on the NIP web site in the near future.

An article in the January 8, 2003, Journal of the American Medical Association (JAMA) by William Thompson and colleagues revisits prior estimates of influenza-associated deaths. New analyses of data suggest that, over the past two decades, substantially more influenza-associated deaths occurred among persons over 65 than was previously estimated. Between 1990 and 1999, an average of about 36,000 influenza-associated deaths occurred annually, a substantial increase over the previous estimated average of 20,000.

In the April 3, 2003 issue of the New England Journal of Medicine (NEJM), Kristin Nichol and colleagues address the benefit of influenza vaccination in reducing the risk of cardiovascular hospitalizations among the elderly during influenza season.

Review web site updates, reference details on influenza vaccination and access free promotional materials at http://www.cdc.gov/nip/flu on CDC's website.

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To access a camera-ready (PDF) version of the bulletin from the Immunization Action Coalition website, go to: http://www.immunize.org/cdc/flubul703.pdf
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July 28, 2003
NEW: JULY ISSUE OF "IMMUNIZATION WORKS!" ELECTRONIC NEWSLETTER AVAILABLE ONLINE

"Immunization Works!" a monthly email newsletter published by the Centers for Disease Control and Prevention, offers members of the immunization community information about current topics. Some of the information in the July issue has already appeared in previous issues of "IAC EXPRESS." Following is the text of four articles we have not covered.

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REMINDER SYSTEMS UNDER HIPAA: The Health Insurance Portability & Accountability Act (HIPAA) of 1996, required adoption of Federal privacy protection for individually identifiable health information. As a result of this law, the question has arisen whether physicians' offices or pharmacists can leave messages for patients at their home answering machine or with a family member to remind them of appointments or to mail appointment or prescription refill reminders.

The answer is yes. Information for immunization reminders may be provided either by phone or postcard. Professional judgment should be used to disclose the least amount of information possible to achieve the  intended purpose. The exception is in instances where a patient requests that the information be provided in a confidential manner, such as by alternative means or at an alternative address. These requests must be accommodated. For the full question and answers regarding privacy under HIPAA refer to www.hhs.gov/ocr/hipaa/privacy.html

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PKIDS LAUNCHES INFECTIOUS DISEASE WORKSHOP: The national nonprofit organization PKIDs (Parents of Kids with Infectious Diseases) has created an infectious disease workshop that teaches  individuals of all ages how to prevent infections in all walks of life. The workshop emphasizes preventive methods such as immunizations and standard precautions. PKIDs free on-line workshop is targeted with information and activities for any age. It is a train-the-trainer program offered free of charge to parents, teachers, health educators, coaches, and day care providers. PKIDs can be downloaded or printed for free  from www.pkids.org/idw.htm or can be purchased on CD-ROM for $30 plus shipping and handling by calling (360) 695-0293 or e-mailing pkids@pkids.org

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INCREASING ADULT VACCINATION RATES: WHATWORKS: WhatWorks, a CD-ROM program, offers primary care providers strategies they can use to increase immunization rates among their adult patients. Continuing education credits for completing this computer-based, interactive program has been extended until January 31, 2004. The program is approved for 2 hours CME, 2.3 hours CNE and .2 hours CEU through CDC. Request a free copy of the program from CDC's immunization publications online order form at www.cdc.gov/nip/publications ["IAC EXPRESS" editor's note: The WhatWorks ordering number is 99-7300].

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2003 Immunization Registry Conference: The 2003 Immunization Registry Conference is scheduled October 27-29, 2003, in Atlanta, Georgia. The conference will bring together a wide constituency of local,  state, federal, and private sector immunization registry partners to promote knowledge and information about the development and use of immunization registries. For additional information about the conference, please visit www.cdc.gov/nip/registry/irc

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To access the entire July issue from the website of the Immunization Action Coalition, go to: http://www.immunize.org/news.d/news703.htm
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July 21, 2003
FDA APPROVES SUPPLEMENT TO INFANRIX LICENSE, ALLOWING PROVIDERS TO GIVE IT AS A FIFTH CONSECUTIVE DTaP DOSE

On July 7, the Food and Drug Administration (FDA) approved a supplement to the license application for Infanrix, a combination diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP). The  approval allows providers to give the vaccine as a fifth consecutive DTaP dose of Infanrix to children age 4-6 years. Previously, the FDA had approved Infanrix for the DTaP three-dose primary series and the DTaP fourth dose, given during the second year of life.

Infanrix is produced by GlaxoSmithKline, Rixensart, Belgium. The company has U.S. headquarters in Research Triangle Park, NC, and Philadelphia, PA.

To access the approval letter from the FDA website, go to:
http://www.fda.gov/cber/approvltr/dtapgla070703L.htm

To access a camera-ready (PDF) version of the 26-page prescribing information (package insert) from the FDA website, go to:
http://www.fda.gov/cber/label/dtapgla070703LB.pdf
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July 28, 2003
JAMA ARTICLE LINKS AUTISM TO ACCELERATED BRAIN GROWTH IN THE FIRST YEAR OF LIFE

On July 16, the "Journal of the American Medical Association" (JAMA) published an article indicating that more than half of the children studied who had been diagnosed with autism spectrum disorder had abnormally accelerated brain growth during their first year or life. The authors suggest that such accelerated brain growth may be an early neurobiological indicator of risk for autism. The article, "Evidence of Brain Overgrowth in the First Year of Life in Autism," is available free of charge from the JAMA website. The abstract follows; the link to the complete article appears at the end of this article.

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ABSTRACT

Context: Autism most commonly appears by 2 to 3 years of life, at which time the brain is already abnormally large. This raises the possibility that brain overgrowth begins much earlier, perhaps before the first clinically noticeable behavioral symptoms.

Objectives: To determine whether pathological brain overgrowth precedes the first clinical signs of autism spectrum disorder (ASD) and whether the rate of overgrowth during the first year is related to neuroanatomical and clinical outcome in early childhood.

Design, Setting, and Participants: Head circumference (HC), body length, and body weight measurements during the first year were obtained from the medical records of 48 children with ASD aged 2 to 5 years who had participated in magnetic resonance imaging studies. Of these children, 15 (longitudinal group) had measurements at 4 periods during infancy: birth, 1 to 2 months, 3 to 5 months, and 6 to 14 months; and 33 (partial HC data group) had measurements at birth and 6 to 14 months (n = 7), and at birth only (n = 28).

Main Outcome Measures: Age-related changes in infants with ASD who had multiple-age measurements, and the relationship of these changes to brain anatomy and clinical and diagnostic outcome at 2 to 5 years were evaluated by using 2 nationally recognized normative databases: cross-sectional normative data from a national survey and longitudinal data of individual growth.

Results: Compared with normative data of healthy infants, birth HC in infants with ASD was significantly smaller (z = 0.66, probability less than .001); after birth, HC increased 1.67 SDs and mean HC was at the 84th percentile by 6 to 14 months. Birth HC was related to cerebellar gray matter volume at 2 to 5 years, although the excessive increase in HC between birth and 6 to 14 months was related to greater cerebral cortex volume at 2 to 5 years. Within the ASD group, every child with autistic disorder had a greater increase in HC between birth and 6 to 14 months (mean [SD], 2.19 [0.98]) than infants with pervasive developmental disorder-not otherwise specified (0.58 [0.35]). Only 6% of the individual healthy infants in the longitudinal data showed accelerated HC growth trajectories (greater than 2.0 SDs) from birth to 6 to 14 months; 59% of infants with autistic disorder showed these accelerated growth trajectories.

Conclusions: The clinical onset of autism appears to be preceded by 2 phases of brain growth abnormality: a reduced head size at birth and a sudden and excessive increase in head size between 1 to 2 months and 6 to 14 months. Abnormally accelerated rate of growth may serve as an early warning signal of risk for autism.

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To access the complete article from the JAMA website, go to:
http://jama.ama-assn.org/cgi/content/full/290/3/337

To access a camera-ready (PDF) version of the article, go to:
http://jama.ama-assn.org/cgi/reprint/290/3/337.pdf

To access a variety of journal articles and other resources on autism from the Immunization Action Coalition's "Autism Information" web page, go to:
http://www.immunize.org/safety/autism.htm
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July 28, 2003
IAC CONTINUALLY UPDATES ITS WEB PAGE ON THE HEPATITIS B VACCINE BIRTH DOSE

In the past several months, the Immunization Action Coalition (IAC) has added lots of new resources to its birth dose web page, titled "Give hepatitis B vaccine at birth to all babies." This web page now features more  than 50 resources divided into three sections: General Information, Recommendations, and Journal Articles. If you haven't looked at the birth dose web page recently, you might want to check out some of the newest resources, listed below.

In the General Information section, IAC is the source of the four documents that have been posted since the beginning of 2003. The four documents are

  1. "It's time to reaffirm the importance of the birth dose recommendation!" Written by IAC executive director Deborah L. Wexler, MD, this is an open letter to the Advisory Committee on Immunization Practices and three major health professional organizations.
     
    To access the camera-ready (PDF) version, go to:
    http://www.immunize.org/birthdose/importance.pdf
     
    To access the HTML version, go to:
    http://www.immunize.org/birthdose/importance.htm

     
  2. "States report hundreds of medical errors in perinatal hepatitis B prevention." Written by IAC's epidemiologist, Teresa A. Anderson, DDS, MPH, and executive director, Deborah L. Wexler, MD, this is a summary of the findings of case reports collected from state hepatitis coordinators across the nation.
     
    To access the camera-ready (PDF) version, go to:
    http://www.immunize.org/catg.d/p2062.pdf
     
    To access the HTML version, go to:
    http://www.immunize.org/catg.d/p2062.htm
     
  3. "Unprotected babies: Two more infants chronically infected with hepatitis B virus . . . the medical errors continue."
     
    To access the camera-ready (PDF) version, go to:
    http://www.immunize.org/catg.d/p2127.pdf
     
    To access the HTML version, go to:
    http://www.immunize.org/catg.d/p2127.htm

     
  4. "Hospitals and doctors sued for failing to protect newborns from hepatitis B transmission."
     
    To access the camera-ready (PDF) version, go to:
    http://www.immunize.org/catg.d/p2061.pdf
     
    To access the HTML version, go to:
    http://www.immunize.org/catg.d/p2061.htm

In the Recommendations section, all six resources are from 2003. The two most current ones follow:

  1. "Immunization of preterm and low birth weight infants," published in "Pediatrics," July 2003; written by Thomas N. Saari, MD, and the American Academy of Pediatrics' Committee on Infectious Diseases.
     
    To access a camera-ready (PDF) version of the complete article from the "Pediatrics" website, go to:
    http://pediatrics.aappublications.org/cgi/reprint/112/1/193.pdf
     
  2. "VFC support for a universal hepatitis B birth dose policy," published by the Centers for Disease Control and Prevention, June 2, 2003.
     
    To access a copy from the IAC website, go to:
    http://www.immunize.org/cdc/hepbmemo.pdf

In the Journal Articles section, six articles have been added in 2003. The three most current follow:

  1. "Impact of thimerosal controversy on hepatitis B vaccine coverage of infants born to women of unknown hepatitis B surface antigen status in Michigan," published in "Pediatrics," June 2003.
     
    To access the abstract from the "Pediatrics" website, go to:
    http://pediatrics.aappublications.org/cgi/content/abstract/111/6/e645
     
  2. "Hepatitis B surface antigen prevalence among pregnant women in urban areas: Implication for testing, reporting, and preventing perinatal transmission," published in "Pediatrics," May 2003.
     
    To access the abstract from the PubMed website, click here.
     
  3. "Vaccination and perinatal infection prevention practices among obstetricians-gynecologists," published in "Obstetrics and Gynecology," April 2003.
     
    To access the abstract from the PubMed website, click here.

You can stay up to date on hepatitis B birth dose information by visiting the IAC birth dose web page often at http://www.immunize.org/birthdose
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July 28, 2003
NEW: CHILDREN'S VACCINE PROGRAM AT PATH POSTS FREE VACCINE ADVOCACY TOOLS ONLINE

The Children's Vaccine Program (CVP) at PATH (Program for Appropriate Technology in Health) recently posted a PowerPoint slide show and a full-color paper on its website. Each makes a strong  case for the health and cost benefits of childhood immunization, the safety of vaccines, and the need for adequate immunization coverage on a global level. Following is a description and ordering information for each.

  • "Childhood Immunization: A Worthwhile Investment." Produced in 2003 by CVP in collaboration with the Global Alliance for Vaccines and Immunization. This 19-slide PowerPoint show is designed to be adapted for different situations. Presenters are encouraged to insert their organizational logo, add or subtract pages, substitute images, and/or revise the text to suit their needs.
     
    To access the PowerPoint presentation from the CVP website, go to: http://childrensvaccine.org/files/Case-for-Immunization.ppt
    You must have PowerPoint installed.
     
  • "The Case for Childhood Immunization." Produced in 2002 by CVP; text written by Mark Kane, MD, MPH, CVP Director, and Heidi Lasher, CVP Advocacy, Communications, and Training Specialist. This colorful 16-page, evidence-based paper is packed with information documenting the many benefits of fully immunizing children.
     
    To access a camera-ready (PDF) version of the paper from the CVP website, go to:
    http://childrensvaccine.org/files/CVP_Occ_Paper5.pdf
     
    To access a variety of information from the CVP home page, go to: http://www.childrensvaccine.org

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July 28, 2003
CDC REPORTS ON POLIO ERADICATION EFFORTS IN AFGHANISTAN AND PAKISTAN

The Centers for Disease Control and Prevention (CDC) published "Progress Toward Poliomyelitis Eradication--Afghanistan and Pakistan, January 2002-May 2003" in the July 25 issue of the "Morbidity  and Mortality Weekly Report" (MMWR). A summary made available to the press is reprinted below in its entirety.

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Since the World Health Assembly resolved in 1988 to eradicate poliomyelitis globally, the number of countries where polio is endemic decreased from 127 to only seven.

Despite significant progress in reducing the scope and genetic diversity of transmission, wild virus circulation continues in Pakistan and Afghanistan. This report summarizes the progress toward polio  eradication in these two countries during January 2002-May 2003, highlighting the progress made in strengthening the acute flaccid paralysis surveillance (AFP) system and the need for further improvements in the quality of the supplementary immunization activities.

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To obtain the complete text of the article online, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5229a3.htm

To obtain a camera-ready (PDF format) copy of this issue of MMWR, go to:
http://www.cdc.gov/mmwr/PDF/wk/mm5229.pdf

HOW TO OBTAIN A FREE ELECTRONIC SUBSCRIPTION TO THE MMWR:
To obtain a free electronic subscription to the "Morbidity and Mortality Weekly Report" (MMWR), visit CDC's MMWR website at: http://www.cdc.gov/mmwr Select "Free Subscription" from the menu at the left of the screen. Once you have submitted the required information, weekly issues of the MMWR and all new ACIP statements (published as MMWR's "Recommendations and Reports") will arrive automatically by email.

 

Immunization Action Coalition1573 Selby AvenueSt. Paul MN 55104
E-mail: admin@immunize.org Web: http://www.immunize.org/
Tel: (651) 647-9009Fax: (651) 647-9131

This page was updated on July 28, 2003