Immunization Action Coalition and the Hepatitis B Coalition

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Issue Number 377            April 7, 2003

CONTENTS OF THIS ISSUE

  1. Neuropathologists write in "Pediatrics" that a link between thimerosal and autism is improbable
  2. Paul Offit's and Charles Hackett's "Pediatrics" article concludes that studies fail to show that vaccines cause chronic diseases
  3. CDC notifies readers about ACIP recommendations for additional exclusion criteria for smallpox vaccination program
  4. New: Immunization Action Coalition launches "HEP EXPRESS" electronic newsletter
  5. FDA approves preservative-free diphtheria and tetanus toxoids adsorbed (DT) for pediatric use
  6. Immunization coalitions to see lots of activity in upcoming weeks
  7. Dr. Carlo Urbani, communicable disease expert, dies of SARS
  8. CDC publishes an update of smallpox vaccine adverse events surveillance
  9. CDC publishes supplemental Recommendations for Using Smallpox Vaccine in a Pre-Event Vaccination Program
  10. CDC report describes hepatitis C virus transmission to organ and tissue recipients of antibody-negative donor
  11. Turn to CDC and WHO Internet sites for current SARS information

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April 7, 2003
NEUROPATHOLOGISTS WRITE IN "PEDIATRICS" THAT A LINK BETWEEN THIMEROSAL AND AUTISM IS IMPROBABLE

"Thimerosal and Autism?" appeared as a commentary article in the March issue of "Pediatrics." It is written by two neuropathologists, Karin B. Nelson, MD, of the National Institute of Neurological Disorders and Stroke, and Margaret L. Bauman, MD, of Harvard Medical School.

After reviewing the scientific literature, the authors conclude a link between thimerosal exposure and the development of autism is improbable. The article, which clearly demonstrates that the characteristics of mercury toxicity and autism are so dissimilar that it would be difficult to confuse  them, will be useful to physicians in allaying parents' concerns about thimerosal content in vaccines.

Following are the article's two concluding paragraphs:

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Mercury poisoning and autism both affect the central nervous system but the specific sites of involvement in brain and the brain cell types affected are different in the two disorders as evidenced  clinically and by neuropathology. Mercury also injures the peripheral nervous system and other organs that are not affected in autism. Nonspecific symptoms such as anxiety, depression, and irrational fears may occur both in mercury poisoning and in children with autism, but overall the clinical picture of mercurism--from any known form, dose, duration, or age of exposure--does not mimic that of autism. No case history has been encountered in which the differential diagnosis of these 2 disorders was a problem. Most important, no evidence yet brought forward indicates that children exposed to vaccines containing mercurials, or mercurials via any other route of exposure, have more autism than children with less or no such exposure.

Continuing vigilance is necessary regarding the safety of vaccines, as is open-minded evaluation of new evidence. However, such evidence must be of sufficient scientific rigor to provide a responsible basis for decisions that influence the safety of children. When information is incomplete, as it is at present for thimerosal-autism questions, a balancing must be made of risks posed by vaccine constituents and the benefits of disease prevention achieved by keeping immunizations widely available. On the basis of current evidence, we consider it improbable that thimerosal and autism are linked.

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Most articles in "Pediatrics" are available only to subscribers. We commend the editor of "Pediatrics" for making this important article available to the broad health care community on the Internet. To access a camera-ready (PDF) copy of the complete article from the "Pediatrics" website, go to: http://www.pediatrics.org/cgi/reprint/111/3/674.pdf

Physicians will be interested in referring parents to Jane Brody's synopsis of the "Pediatrics" article, "Vaccines and Autism, Beyond the Fear Factor." To access it from the "New York Times" website, go to: http://www.nytimes.com/pages/health Scroll down the right-hand column, and click on "More Personal Health Columns."
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April 7, 2003
PAUL OFFIT'S AND CHARLES HACKETT'S "PEDIATRICS" ARTICLE CONCLUDES THAT STUDIES FAIL TO SHOW THAT VACCINES CAUSE CHRONIC DISEASES

"Addressing Parents' Concerns: Do Vaccines Cause Allergic or Autoimmune Diseases?" concludes  that epidemiologic studies fail to show that vaccines cause chronic disease. The article appears in the March issue of "Pediatrics." It is written by Paul A. Offit, MD, of Children's Hospital of Philadelphia, the University of Pennsylvania School of Medicine, and the Wistar Institute of Anatomy and Biology, Philadelphia, and Charles J. Hackett, PhD, of the National Institutes of Allergy and Infectious Diseases. The abstract is reprinted below in its entirety.

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ABSTRACT. Anecdotal case reports and uncontrolled observational studies in the medical literature claim that vaccines cause chronic diseases such as asthma, multiple sclerosis, chronic arthritis, and diabetes. Several biological mechanisms have been proposed to explain how vaccines might cause allergic or autoimmune diseases. For example, allergic diseases might be caused by prevention of  early childhood infections (the "hygiene hypothesis"), causing a prolongation of immunoglobulin E-promoting T-helper cell type 2-type responses. However, vaccines do not prevent most common childhood infections, and large well-controlled epidemiologic studies do not support the hypothesis that  vaccines cause allergies. Autoimmune diseases might occur after immunization because proteins on microbial pathogens are similar to human proteins ("molecular mimicry") and could induce immune responses that damage human cells. However, wild-type viruses and bacteria are much better adapted to growth in humans than vaccines and much more likely to stimulate potentially damaging self-reactive  lymphocytes. Consistent with critical differences between natural infection and immunization, well-controlled epidemiologic studies do not support the hypothesis that vaccines cause autoimmunity.

Flaws in proposed biological mechanisms that explain how vaccines might cause chronic diseases are consistent with the findings of many well-controlled large epidemiologic studies that fail to show a causal relationship.

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Most articles in "Pediatrics" are available only to subscribers. We commend the editor of "Pediatrics" for making this important article available to the broad health care community on the Internet. To access a camera-ready (PDF) copy of the complete article from the "Pediatrics" website, go to: http://www.pediatrics.org/cgi/reprint/111/3/653.pdf
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April 7, 2003
CDC NOTIFIES READERS ABOUT ACIP RECOMMENDATIONS FOR ADDITIONAL EXCLUSION CRITERIA FOR SMALLPOX VACCINATION PROGRAM

The Centers for Disease Control and Prevention (CDC) published a Notice to Readers, "Supplemental Recommendations on Adverse Events Following Smallpox Vaccine in the Pre-Event Vaccination Program: Recommendations of the Advisory Committee on Immunization Practices [ACIP]" in the April 4 issue of the "Morbidity and Mortality Weekly Report" (MMWR). The opening paragraph and the three concluding paragraphs are reprinted below.

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[opening paragraph]
The Advisory Committee on Immunization Practices (ACIP) has issued recommendations previously for use of smallpox vaccine and supplemental recommendations for use of smallpox vaccine in the pre-event civilian vaccination program. On March 28, 2003, CDC reported cases of cardiac adverse events among persons vaccinated recently with smallpox vaccine. In response to these reports, ACIP held an emergency meeting on March 28 to make recommendations to CDC about medical screening of potential vaccinees and follow-up of persons with cardiovascular risk factors after vaccination. These recommendations supplement those previously issued by ACIP.

[concluding paragraphs]
These data are consistent with a causal relation between myocarditis/pericarditis and smallpox vaccination, but no causal association between the ischemic cardiac events and smallpox vaccination has been identified. In response to these reports, CDC issued a health advisory on March 26, recommending as a precautionary measure that persons with known cardiac disease not be  vaccinated as response team members in the pre-event smallpox vaccination program at this time. Persons receiving smallpox vaccine should be informed that myopericarditis is a potential complication of smallpox vaccination and that they should seek medical attention if they develop chest pain, shortness of breath, or other symptoms of cardiac disease within 2 weeks after vaccination.

ACIP recommends that persons be excluded from the pre-event smallpox vaccination program who have known underlying heart disease, with or without symptoms, or who have three or more known major cardiac risk factors (i.e., hypertension, diabetes, hypercholesterolemia, heart disease at age 50 years in a first-degree relative, and smoking). ACIP supported including these risk factors in prevaccination education materials so that potential vaccinees can evaluate their risk status, if they have concerns, with their personal physician before reporting for vaccination; at the vaccination clinic, verbal screening for known risk factors is recommended. In response to these recommendations, prevaccination screening forms and other materials have been revised; these materials have been provided to state health departments and are available at http://www.bt.cdc.gov/agent/smallpox.

ACIP did not recommend special medical follow-up for persons with cardiovascular risk factors who have been vaccinated. Persons with risk factors or known atherosclerotic coronary artery disease should be cared for by their physicians in accordance with standard guidelines for treatment and control of these conditions, such as those issued by the National Cholesterol Education Program Expert Panel and other expert groups.

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To obtain the complete text of the report online, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5213a5.htm

To obtain a camera-ready (PDF format) copy of the report, go to:
http://www.cdc.gov/mmwr/PDF/wk/mm5213.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.
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April 7, 2003
NEW: IMMUNIZATION ACTION COALITION LAUNCHES "HEP EXPRESS" ELECTRONIC NEWSLETTER

March 31 saw the publication of the first issue of "HEP EXPRESS," the latest Immunization Action Coalition (IAC) electronic newsletter. Intended for health and social service professionals involved in the prevention and treatment of viral hepatitis, "HEP EXPRESS" will be published at least once a month, as news develops.

"Right now, I foresee "HEP EXPRESS" augmenting the viral hepatitis information covered in "IAC EXPRESS," said managing editor Teresa A. Anderson, DDS, MPH. "Some information, particularly on hepatitis C, will be unique to "HEP EXPRESS."

"HEP EXPRESS" will include the following information on hepatitis A, B, and C: new resources for health professionals and patients, diagnosis and treatment updates, relevant recommendations from the Centers for Disease Control and Prevention and the National Institutes of Health, and links to other websites.

To sign up to have "HEP EXPRESS" delivered directly to your email box, go to:
http://www.hepprograms.org/hepexpress/signup.asp

To read the premiere issue, go to:
http://www.hepprograms.org/hepexpress/issue1.asp

To visit the "HEP EXPRESS" home page, go to:
http://www.hepprograms.org/hepexpress
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April 7, 2003
FDA APPROVES PRESERVATIVE-FREE DIPHTHERIA AND TETANUS TOXOIDS ADSORBED (DT) FOR PEDIATRIC USE

On January 29, the Food and Drug Administration (FDA) approved a supplement to the biologics license application for Diphtheria and Tetanus Toxoids Adsorbed (DT), for Pediatric Use, manufactured by Aventis Pasteur, to include the addition of a preservative-free, single-dose-vial presentation.

To review the product approval letter, go to:
http://www.fda.gov/cber/approvltr/diphave012903L.htm
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April 7, 2003
IMMUNIZATION COALITIONS TO SEE LOTS OF ACTIVITY IN UPCOMING WEEKS

This year, spring will give members of immunization coalitions lots of opportunities for networking and sharing resources and ideas--all with the aim of increasing immunization rates across the life span. Here are four activities coalition members are urged to participate in over the next two months.

NATIONAL INFANT IMMUNIZATION WEEK (NIIW)
If your coalition is involved with childhood immunization, you will want to participate in National Infant Immunization Week, scheduled for April 13-19. NIIW emphasizes immunizing infants against 11 vaccine-preventable diseases by the age of two.

More than 500 communities across the nation are expected to take part in this important week by planning community awareness and media events to promote infant immunizations to parents, care givers, health care providers, and the general community.

To help in planning community activities, the National Immunization Program's NIIW web pages offer ideas for creating an NIIW kickoff event. Sample public relations materials, posters, flyers, web-link icons, tri-fold brochures, and other resources are also available.

To access these materials, go to the NIIW web pages at
http://www.cdc.gov/nip/publications/niiw

IMMUNIZATION COALITION CONFERENCE
The Fifth National Immunization Coalition Conference will take place at the Westin Kierland Resort and Spa in Phoenix-Scottsdale, AZ, on May 28-30, 2003. The conference theme, "An Oasis of Ideas in Arizona," describes the goal of the meeting, which is to be a wellspring of information, resources, and skills-building sessions designed to refresh and "grow" immunization coalitions at every stage of development. It will offer sessions tailored to local, state, and national coalitions, and address childhood, adolescent, and adult immunization issues as they relate to coalition efforts.

For a copy of the conference brochure, go to:
http://www.hsc.usf.edu/publichealth/conted/iz03.html

For questions about program or content, contact Debbie McCune Davis, Program Director, by phone at (602) 253-0090, ext. 234 or by email at tapi@aachc.org

IMMUNIZATION COALITION SUSTAINABILITY PROJECT
Created to identify effective immunization coalitions and communicate their success to others, the Immunization Coalition Sustainability Project (ICSP) will conduct a nationwide survey of state and local immunization coalitions in April.

Data gathered in the survey will be compiled into a catalog featuring the best practices and best materials developed by coalitions. The catalog will be distributed to immunization coalitions in ICSP's  nationwide database. ICSP's findings will be presented at the Centers for Disease Control and Prevention's National Immunization Conference in 2004.

To ensure your coalition is entered in the ICSP database and represented in the survey, sign up at
http://www.bakalianconsulting.com

For additional information, call Pat Bakalian at (831) 420-1935, or email her at pat@bakalianconsulting.com

"IZ COALITIONS" WEBSITE
Since launching its "IZ Coalitions" website in January 2002, the Immunization Action Coalition (IAC) has posted information from 122 immunization coalitions. The site includes data from coalitions at all levels (local, state, regional, national, and international) and of all types, vaccine-specific as well as age-specific (childhood, adult, senior).

This online database allows health professionals, parents, immunization advocates, and others to contact specific coalitions to find resources, share ideas, and form strategic partnerships. Searches can be done by name or geographic area.

Be sure your coalition is part of this powerful web-based networking tool by logging on and signing up today. If you're already signed up, and information about your coalition has changed recently, be sure to update your listing to help us keep the site current and accurate.

To search the "IZ Coalitions" site or add your coalition to it, go to:
http://www.izcoalitions.org
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April 7, 2003
DR. CARLO URBANI, COMMUNICABLE DISEASE EXPERT, DIES OF SARS

The World Health Organization issued a press release on March 29 about the death of Dr. Carlo Urbani. It is reprinted below in its entirety.

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29 March 2003
Geneva

Dr. Carlo Urbani, an expert on communicable diseases, died today of Severe Acute Respiratory Syndrome (SARS). Dr. Urbani worked in public health programs in Cambodia, Laos, and Viet Nam. He was based in Hanoi, Viet Nam. Dr. Urbani was 46.

Dr. Urbani was the first World Health Organization (WHO) officer to identify the outbreak of this new disease, in an American businessman who had been admitted to a hospital in Hanoi. Because of his early detection of SARS, global surveillance was heightened and many new cases have been identified and isolated before they infected hospital staff. In Hanoi, the SARS outbreak appears to be coming under control.

"Carlo was a wonderful human being and we are all devastated," said Pascale Brudon, the WHO Representative in Viet Nam. "He was very much a doctor, his first goal was to help people. Carlo was the one who very quickly saw that this was something very strange. When people became very concerned in the hospital, he was there every day, collecting samples, talking to the staff, and strengthening infection control procedures."

Dr. Urbani was married and the father of three children.

Dr. Urbani received his medical degree from the University of Ancona, Italy, and did post-graduate work in malaria and medical parasitology. He was an expert in the parasitic diseases of schoolchildren. He was also a president of Médecins Sans Frontieres-Italy.

"Carlo Urbani's death saddens us all deeply at WHO," said Dr. Gro Harlem Brundtland, WHO's Director-General. "His life reminds us again of our true work in public health. Today, we should all pause for a moment and remember the life of this outstanding physician."

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To access a copy of the press release from the WHO website, go to:
http://www.who.int/mediacentre/notes/2003/np6/en
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April 7, 2003
CDC PUBLISHES AN UPDATE OF SMALLPOX VACCINE ADVERSE EVENTS SURVEILLANCE

The Centers for Disease Control and Prevention (CDC) published "Update: Adverse Events Following Smallpox Vaccination—United States, 2003" in the April 4 issue of the "Morbidity and Mortality Weekly Report" (MMWR). The opening paragraph is reprinted below.

"During January 24-March 28, 2003, smallpox vaccine was administered to 29,584 civilian health-care and public health workers in 54 jurisdictions as part of an effort to prepare the United States for a terrorist attack using smallpox virus. This report summarizes data on ten cases of cardiac adverse events reported among civilian vaccinees since the beginning of the smallpox vaccination program,  including three new cardiac adverse events reported to CDC from the Vaccine Adverse Event Reporting System (VAERS) during March 24-30. Fourteen cases of myocarditis and one fatal myocardial infarction have been reported among military personnel. This report summarizes data on the three new cases of cardiac adverse events, updates data on seven previously reported cases among civilian vaccinees, summarizes selected cases of cardiac adverse events among military vaccinees, and updates information on all adverse events reported in the civilian vaccination program as of March 30."

To obtain the complete text of the article online, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5213a4.htm

To obtain a camera-ready (PDF format) copy of this issue of MMWR, go to:
http://www.cdc.gov/mmwr/PDF/wk/mm5213.pdf
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April 7, 2003
CDC PUBLISHES SUPPLEMENTAL RECOMMENDATIONS FOR USING SMALLPOX VACCINE IN A PRE-EVENT VACCINATION PROGRAM

The Centers for Disease Control and Prevention (CDC) published "Recommendations for Using Smallpox Vaccine in a Pre-Event Vaccination Program: Supplemental Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Healthcare Infection Control Practices Advisory Committee (HICPAC)" in the April 4 issue of the "MMWR Recommendations and Reports" (MMWR). Originally published in the web-based "MMWR Dispatch," the report has not been available in hard-copy format until now.

The 16-page report includes information on preoutbreak vaccination of selected groups, vaccination method, contraindications, simultaneous administration of smallpox vaccine with other vaccines, and reporting and managing adverse events.

To obtain the complete text of the report online, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5207a1.htm

To obtain a camera-ready (PDF format) copy of the report, go to:
http://www.cdc.gov/mmwr/PDF/rr/rr5207.pdf
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April 7, 2003
CDC REPORT DESCRIBES HEPATITIS C VIRUS TRANSMISSION TO ORGAN AND TISSUE RECIPIENTS OF ANTIBODY-NEGATIVE DONOR

The Centers for Disease Control and Prevention (CDC) published "Hepatitis C Transmission from an Antibody-Negative Organ and Tissue Donor--United States, 2000-2002" in the April 4 issue of the "Morbidity and Mortality Weekly Report" (MMWR). Part of a summary made available to the press is reprinted below.

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This report describes HCV transmission to recipients of organs or tissues from a donor who had tested negative for HCV infection using a screening antibody test. A patient developed acute hepatitis C after receiving a tissue transplant from a donor. We performed an additional test on the donor's stored serum and detected the RNA of the virus. He was likely in an early phase of infection before the development of detectable antibodies. The donor was the source of HCV infection for 8 recipients of organs or tissues. Although HCV transmission from antibody-negative donors is likely uncommon, determining the frequency of such transmission will be important in evaluating whether additional prevention measures are warranted.

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To obtain the complete text of the report online, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5213a2.htm

To obtain a camera-ready (PDF format) copy of the report, go to:
http://www.cdc.gov/mmwr/PDF/wk/mm5213.pdf
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April 7, 2003
TURN TO CDC AND WHO INTERNET SITES FOR CURRENT SARS INFORMATION

As of April 5, there have been 2,416 reported cases of Severe Acute Respiratory Syndrome (SARS)  worldwide and 89 reported deaths. In recent weeks, the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) have issued health alerts and announcements about SARS.

In addition, each organization has posted extensive information about the disease. Health professionals are urged to keep themselves informed by visiting the CDC and WHO web pages.

To access the CDC SARS web pages, go to:
http://www.cdc.gov/ncidod/sars

To access the WHO SARS web pages, go to:
http://www.who.int/csr/sars/en

 

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 April 7, 2003