Issue
Number 401
July 28, 2003
CONTENTS OF THIS ISSUE
- New: National Immunization Program publishes "Influenza
Vaccine Bulletin #2" for influenza season 2003-04
- New: July issue of "Immunization Works!" electronic newsletter
available online
- FDA approves supplement to Infanrix license, allowing
providers to give it as a fifth consecutive DTaP dose
- JAMA article links autism to accelerated brain growth in the
first year of life
- IAC continually updates its web page on the hepatitis B
vaccine birth dose
- New: Children's Vaccine Program at PATH posts free vaccine
advocacy tools online
- 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
- "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
- "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
- "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
- "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:
- "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
- "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:
- "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
- "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.
- "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.
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