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IAC Express 2007 |
| Issue number 670: June 18, 2007 |
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Contents
of this Issue
Select a title to jump to the article. |
- FDA
approves revised label for RotaTeq; CDC provides information about the
change
- New: July
2007 issue of Vaccinate Women is on the IAC website
- IAC
introduces new pieces that answer patients' questions about tetanus,
rubella, polio, meningococcal, and rotavirus
- June
issue of CDC's Immunization Works electronic newsletter now available
online
- Current
Issues in Immunization net conference to focus on immunizations for
healthcare personnel--registration is limited
- Mark your
calendar: August 9 is the date for CDC's live satellite broadcast
"Immunization Update 2007"
- New VIS
translation: VIS for DTaP vaccine now available in Turkish
- Former
CDC director writes about changes in public health from 1993-1998
- HHS
awards two contracts to expand domestic influenza vaccine manufacturing
capacity
- WHO and
vaccine manufacturers to continue progress on plan to create global
stockpile of H5N1 avian influenza vaccine
- HHS
convenes leadership forum to help U.S. prepare for possible influenza
pandemic
- MMWR
notifies readers that WHO will update the recommended nomenclature for
wild-type rubella viruses
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| Abbreviations |
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AAFP, American Academy of Family Physicians; AAP,
American Academy of Pediatrics; ACIP, Advisory Committee on Immunization
Practices; AMA, American Medical Association; CDC, Centers for Disease
Control and Prevention; FDA, Food and Drug Administration; IAC, Immunization
Action Coalition; MMWR, Morbidity and Mortality Weekly Report; NCIRD,
National Center for Immunization and Respiratory Diseases; NIVS, National
Influenza Vaccine Summit; VIS, Vaccine Information Statement; VPD,
vaccine-preventable disease; WHO, World Health Organization. |
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Issue 670: June 18, 2007 |
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1. |
FDA approves revised label for RotaTeq; CDC provides information about the
change
On June 15, CDC posted information online related
to a change in label for RotaTeq rotavirus vaccine. The first four paragraphs
follow.
Important Information Regarding Kawasaki Disease
and RotaTeq Vaccine
The Food and Drug Administration (FDA) approved today a revised
label for RotaTeq, a rotavirus vaccine manufactured by Merck and
Co., Inc. (http://www.fda.gov/cber/products/rotateq.htm), to
include information on reports of Kawasaki disease occurring
before and after the vaccine's licensure in February 2006. FDA
has not made any changes to its indications for use of RotaTeq
nor has it issued new or revised warnings or precautions.
Likewise, the Centers for Disease Control and Prevention (CDC)
has not made any changes in its recommendations regarding the
use of RotaTeq. Healthcare providers and parents should remain
confident in using RotaTeq in infants.
The FDA reports that five cases of Kawasaki disease have been
identified in children less than 1 year of age who received the
RotaTeq vaccine during clinical trials conducted before the
vaccine was licensed. Three reports of Kawasaki disease were
detected following the vaccine's approval in February 2006
through routine monitoring using the Vaccine Adverse Event
Reporting System (VAERS). After learning about these Kawasaki
disease reports, CDC identified one additional unconfirmed case
through its Vaccine Safety Datalink (VSD) Project. The vaccine
label has been revised to notify healthcare providers and the
public about the reports of Kawasaki disease following RotaTeq
vaccination.
The number of Kawasaki disease reports does not exceed the
number of cases we expect to see based on the usual occurrence
of Kawasaki disease in children. There is not a known cause-and-effect relationship between receiving RotaTeq or any other
vaccine and the occurrence of Kawasaki disease.
The available data support the safety of the RotaTeq vaccine and
its effectiveness in preventing rotavirus infection, a common
cause of severe infant diarrhea and hospitalization. CDC and FDA
continue to monitor the safety of RotaTeq and all vaccines. . .
The text continues with seven key facts. To read the complete
article, go to:
http://www.cdc.gov/od/science/iso/concerns/kawasaki_disease_rotavirus.htm
To access the revised label information, go to:
http://www.fda.gov/cber/label/rotateqLB.pdf
To access information pertaining to the RotaTeq labeling
revision from FDA, go to:
http://www.fda.gov/cber/label/rotateqLBinfo.htm
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2. |
New: July 2007 issue of Vaccinate Women is on the IAC website
The July 2007 issue of Vaccinate Women is now
available on the
IAC website. Printed copies will soon be mailed to all members
of the American College of Obstetricians and Gynecologists
(ACOG), local and state health departments, and thousands of
other subscribers. This publication was supported by a
cooperative grant by the Division of Viral Hepatitis at the
Centers for Disease Control and Prevention.
You can view selected articles from the table of contents below
or download the entire issue from the Web.
To download a ready-to-print (PDF) version of the entire issue,
go to: http://www.immunize.org/vw/vw0707.pdf
The PDF file of
the entire issue is large. For tips on downloading and printing
PDF files, go to: http://www.immunize.org/nslt.d/tips.htm
To view the table of contents with links to individual articles,
go to: http://www.immunize.org/vw
The July issue includes several notable articles: Ask the
Experts, Summary of Recommendations for Adult Immunization, and
two professional-education pieces and three patient-screening
questionnaires on viral hepatitis. In addition, a new
professional-education piece presents links to vaccination
resources every practice should have, including links to
resources that help decide who needs to be vaccinated and how to
administer vaccines; all can be downloaded. The issue also
provides links to immunization schedules for patients of
different ages, all of which can be downloaded.
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3. |
IAC introduces new pieces that answer patients' questions about tetanus,
rubella, polio, meningococcal, and rotavirus
IAC recently developed ready-to-print versions of
some of the
CDC-reviewed Q&A material located on IAC's Vaccine Information
website (www.vaccineinformation.org). The website is intended
for the public, health professionals, and the media.
The newly formatted Q&As present information on the following
diseases and vaccines: tetanus, rubella, polio, meningococcal,
and rotavirus. In the next several weeks, IAC Express will
announce the availability of more ready-to-print Q&As on
additional vaccine-preventable diseases and vaccines.
Organized in an easy-to-follow Q&A format, these pieces can be
printed and handed out to patients to help educate them about
the seriousness of VPDs and the importance of vaccination. Links
to the new ready-to-print Q&As follow:
To access "Tetanus: Questions and Answers," go to:
http://www.immunize.org/catg.d/p4220.pdf
To access "Rubella: Questions and Answers," go to:
http://www.immunize.org/catg.d/p4218.pdf
To access "Polio: Questions and Answers," go to:
http://www.immunize.org/catg.d/p4215.pdf
To access "Meningococcal: Questions and Answers," go to:
http://www.immunize.org/catg.d/p4210.pdf
To access "Rotavirus: Questions and Answers, go to:
http://www.immunize.org/catg.d/p4217.pdf
In the June 4 and June 11 issues of IAC Express, we announced
newly formatted Q&As on the following diseases and vaccines:
mumps, pertussis, PPV, hepatitis A, hepatitis B, and measles.
Following are the direct links to them:
To access "Mumps: Questions and Answers," go to:
http://www.immunize.org/catg.d/p4211.pdf
To access "Pertussis: Questions and Answers," go to:
http://www.immunize.org/catg.d/p4212.pdf
To access "PPV: Questions and Answers," go to:
http://www.immunize.org/catg.d/p4213.pdf
To access "Hepatitis A: Questions and Answers," go to:
http://www.immunize.org/catg.d/p4204.pdf
To access "Hepatitis B: Questions and Answers," go to:
http://www.immunize.org/catg.d/p4205.pdf
To access "Measles: Questions and Answers," go to:
http://www.immunize.org/catg.d/p4209.pdf
To access IAC's online disease/vaccine Q&A material for patients
and parents, go to: http://www.vaccineinformation.org and click
on the pertinent link(s).
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4. |
June issue of CDC's Immunization Works electronic newsletter now available
online
The June issue of Immunization Works, a monthly
email newsletter
published by CDC, is available on the website of the National
Center for Immunization and Respiratory Diseases (NCIRD). The
newsletter offers members of the immunization community non-proprietary information about current topics. CDC encourages its
wide dissemination.
Some of the information in the June issue has already appeared
in previous issues of IAC Express. Following is the text of four
articles we have not covered.
FRONT PAGE NEWS
NCIRD LAUNCHES NEW WEBSITE: CDC's National Center for
Immunization and Respiratory Diseases (NCIRD) launched its new
vaccines and immunization website on June 11, 2007. The site,
http://www.cdc.gov/vaccines, replaced
http://www.cdc.gov/nip,
and features a new look, a new feel, and many more resources.
The website format, which was redesigned using web usability
testing, has changed to a topic-driven layout. This change in
format makes it easier for healthcare professionals, parents,
and immunization partners, to quickly find accurate vaccine and
immunization information. For partners that have a website that
currently links to the http://www.cdc.gov/nip website, all these
URLs should be changed. Please ACT NOW! To assist with this
task, submit a list of all the URLs that need to be changed
using an online request new URLs form (located at
http://www.cdc.gov/vaccines/about/contact/url-request-form.htm)
A list of all the new URL links will be provided.
NCIRD is committed to providing the latest and most credible
immunization information. Be sure to bookmark
http://www.cdc.gov/vaccines and visit often as improvements and
innovations are ongoing. Please provide suggestions and feedback
about the new website via email to ncirdwebteam@cdc.gov
OTHER NEWS & SUMMARIES
CDC'S IMMUNIZATION STAFF WIN NATIONAL AWARDS:
Recently, staff
members from CDC's National Center for Immunization and
Respiratory Diseases (NCIRD) have been recognized through
national awards for their public health leadership and valued
contributions to public health research and practice. On March
19, CDC celebrated the ceremonial swearing-in of NCIRD's
director, Anne Schuchat, MD, as rear admiral in the Commissioned
Corps of the United States Public Health Service. As a flag
officer, Dr. Schuchat joins an elite group--there are only about
50 flag officers in the corps today. More information about Dr.
Schuchat's award can be found at
http://www.cdc.gov/news/2007/03/schuchat.html On May 7, NCIRD's
senior advisor, Larry Pickering, MD, was awarded the 2007
Pediatric Infectious Diseases Society's Distinguished Physician
Award for his contributions and accomplishments in pediatric
infectious disease. The award is given annually to a
pediatrician whose clinical work, research, and teachings have
been recognized both nationally and internationally over a long
period of time. More information about Dr. Pickering's award can
be found at http://www.cdc.gov/news/2007/05/pickering.html On
May 18, NCIRD's Elizabeth Zell was selected as a Fellow of the
American Statistical Association (ASA), the nation's preeminent
professional statistical society. This honor is bestowed on less
than half of one-percent of ASA members for their outstanding
professional contributions to and leadership in the field of
statistical science. More information about Ms. Zell's award can
be found at
http://www.amstat.org/pressroom/index.cfm?fuseaction=2007fellows
FINAL GUIDANCES FOR PANDEMIC AND SEASONAL INFLUENZA VACCINES:
The U.S. Food and Drug Administration (FDA) today [May 31]
issued final recommendations to increase the supply of safe and
effective influenza vaccines for both seasonal and pandemic use.
FDA's goal with the guidances is to outline the regulatory
pathways for the rapid development and approval of these
products. In March 2006, FDA issued two draft guidance documents
for public comment--one for seasonal influenza vaccines and
another for pandemic influenza vaccines. The draft documents
outline specific approaches for manufacturers to develop new
vaccines that are safe, pure, and potent. The final guidances
reflect public input, including vaccine companies and public
health officials. Both guidances recommend using recent
technologies such as cell culture and recombinant manufacturing
to enhance the development and evaluation of vaccines. They also
recommend adding substances that improve the immune response
from the vaccine (novel adjuvants). More information can be
found in FDA's press release at
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01645.html
MEETINGS, CONFERENCES & RESOURCES
LEARN ABOUT AVIAN INFLUENZA A (H5N1): A new three-day online
training course provides a standardized curriculum to state and
local public health responders about how to identify and control
human infections and illness associated with avian influenza A
(H5N1). The course, titled "CDC/CSTE Rapid Response Training:
The Role of Public Health in a Multi-Agency Response to Avian
Influenza in the United States," is the result of a partnership
between the Centers for Disease Control and Prevention (CDC) and
the Council of State and Territorial Epidemiologists (CSTE).
The course is available at http://www.cste.org/influenza/avian.asp
To access the complete June issue from CDC's Vaccines &
Immunizations website, go to:
http://www.cdc.gov/vaccines/news/newsltrs/imwrks/2007/200706.htm
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5. |
Current Issues in Immunization net conference to focus on immunizations for
healthcare personnel--registration is limited
[The following is cross posted from CDC's
Immunization Works
electronic newsletter, June 2007.]
UPCOMING IMMUNIZATION NET CONFERENCE: Please mark your calendars
for the next National Center for Immunization and Respiratory
Diseases (NCIRD) net conference, Current Issues in Immunization,
scheduled for July 12, 2007, from 12 noon to 1 pm Eastern Time
and titled Healthcare Personnel--What Immunizations are Advised?
The NCIRD Immunization Training Team will review vaccines
recommended for healthcare personnel who have direct patient
contact. Discussion will highlight current recommendations,
rationale for changes, and issues facing healthcare providers
when considering their personal immunizations. This is a
limited-entry event, so please register early to guarantee a
slot. To register, visit
http://www.cdc.gov/vaccines/ed/netconferences.htm
Please note: the October net conference will present travel
health issues including malaria.
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6. |
Mark your calendar: August 9 is the date for CDC's live satellite broadcast
"Immunization Update 2007"
The live satellite broadcast and webcast
"Immunization Update
2007" will provide up-to-date information on the rapidly
changing field of immunization. Anticipated topics include
influenza, rotavirus, varicella, and zoster vaccines; the safety
of thimerosal-containing vaccines; and other emerging vaccine
issues.
The 2.5-hour broadcast is scheduled for August 9 from 9AM to
11:30AM ET; it will be re-broadcast later in the day from 12
noon to 2:30PM ET. Both broadcasts will feature a live question-and-answer session in which participants nationwide can interact
with the course instructors on toll-free telephone lines.
Faculty. The course instructors include William L. Atkinson, MD,
MPH; Donna L. Weaver, MN, RN; and Andrew T. Kroger, MD, MPH. All
are with the CDC's National Center for Immunization and
Respiratory Diseases.
Audience. The program's intended audience includes physicians,
nurses, nurse practitioners, physician assistants, Department of
Defense paraprofessionals, pharmacists, health educators, and
their colleagues who either administer vaccines or set policy
for their offices, clinics, or communicable disease or infection
control programs. Private and public healthcare providers,
including pediatricians, family practice specialists, residents,
and medical and nursing students are encouraged to participate.
Registration. Registration is not required. HOWEVER, ONLINE
REGISTRATION IS REQUIRED TO RECEIVE CONTINUING EDUCATION
CREDITS. To register, go to: http://www2a.cdc.gov/phtnonline
Individual registration begins July 12.
Questions. For additional registration information, email
ce@cdc.gov or call (800) 418-7246. For additional program
information, send an email to nipinfo@cdc.gov
Webcast. The program will have a live webcast at
http://www2a.cdc.gov/PHTN/webcast/immup-2007
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7. |
New VIS translation: VIS for DTaP vaccine now available in Turkish
Dated 5/17/07, the current version of the VISs
for pediatric
diphtheria-tetanus-acellular pertussis (DTaP) vaccine is now
available on the IAC website in Turkish. IAC gratefully
acknowledges pediatrician Mustafa Kozanoglu, MD, and pediatric
hematologist Murat Serbest, MD, for the translation.
To obtain a ready-to-print (PDF) version of the VIS for DTaP
vaccine in Turkish, go to:
http://www.immunize.org/vis/tudtap01.pdf
To obtain it in English, go to:
http://www.immunize.org/vis/dtap01.pdf
For information about the use of VISs, and for VISs in more than
30 languages, visit IAC's VIS web section at
http://www.immunize.org/vis
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8. |
Former CDC director writes about changes in public health from 1993-1998
CDC published "CDC's 60th Anniversary: Director's
Perspective--David Satcher, MD, PhD" in the June 15 issue of MMWR. The years
1993-1998 saw the following progress in programs necessary to
protect the nation's health: first, CDC continued momentum in
several important programs; second, CDC's infrastructure was
strengthened in terms of resources, programs, and organization;
and third, CDC responded to the emerging epidemic of overweight
and obesity and the need to encourage healthy lifestyle choices.
The article cites many examples of activities that helped
fulfill these objectives. One specifically related to
immunization is the increase in childhood vaccination rates. The
related section of the article is reprinted below.
One of the most important challenges and opportunities facing
CDC in the mid-1990s was to increase vaccination rates among
children by the age of 2 years. In 1991, only slightly more than
50% of children were fully vaccinated by this age; the goal was
to dramatically increase that rate to 90% by the end of the
decade, and the 3-year goal was set at 75%. CDC was charged by
Congress with implementing the Vaccines for Children program, a
novel vaccine-financing approach introduced in 1994 that
included access to government-funded vaccines through private-sector providers in addition to traditional public clinics.
CDC's partnerships with the Congress of National Black Churches;
the Women, Infants, and Children program; the National Council
of La Raza; and the National Council of Churches USA were
particularly important in achieving vaccination goals. Likewise,
CDC worked with foundations, including the Annie E. Casey
Foundation, the Robert Wood Johnson Foundation, and the Task
Force for Child Survival and Development to develop vaccine
registries so that healthcare providers would know the
vaccination status of children who were being treated in their
offices. In cities where vaccination rates were especially low,
such as Detroit, Michigan (29%), CDC's partnership with the
mayor's office was critical. . . .
To access a web-text (HTML) version of the complete article, go
to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5623a3.htm
To access a ready-to-print (PDF) version of this issue of MMWR,
go to: http://www.cdc.gov/mmwr/PDF/wk/mm5623.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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9. |
HHS
awards two contracts to expand domestic influenza vaccine manufacturing capacity
On June 15 the Department of Health and Human
Services (HHS)
issued a press release titled "HHS Awards Two Contracts to
Expand Domestic Vaccine Manufacturing Capacity for a Potential
Influenza Pandemic." Portions of it are reprinted below.
HHS Secretary Mike Leavitt today announced the award of two
contracts to expand the domestic influenza vaccine manufacturing
capacity that could be used in the event of a potential
influenza pandemic.
The department has awarded two cost-reimbursable contracts
totaling $132.5 million to sanofi pasteur and MedImmune over
five years to retrofit existing domestic vaccine manufacturing
facilities on a cost-sharing basis and to provide warm-base
operations for manufacturing pandemic influenza vaccines. . . .
To access the complete press release, go to:
http://www.hhs.gov/news/press/2007pres/06/pr20070614a.html
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10. |
WHO and vaccine manufacturers to continue progress on plan to create global
stockpile of H5N1 avian influenza vaccine
On June 13, WHO issued a statement titled "WHO
and Manufacturers
Move Ahead with Plans for H5N1 Influenza Global Vaccine
Stockpile." Portions of the statement are reprinted below.
The World Health Organization (WHO) today announced that it is
working with vaccine manufacturers to move ahead on plans to
create a global stockpile of vaccine for the H5N1 avian
influenza virus.
The announcement follows a request by the World Health Assembly
in May for WHO to establish an international stockpile of H5N1
vaccine.
Also on Wednesday, WHO welcomed the announcement by
GlaxoSmithKline that it will contribute to the H5N1 global
vaccine stockpile. Omninvest of Hungary, Baxter, and sanofi
pasteur have also indicated their willingness to make some of
their H5N1 vaccine available.
"This is another significant step towards creating a global
resource to help the world and especially to help developing
countries in case of a major outbreak of H5N1 avian influenza,"
said Dr. Margaret Chan, WHO Director-General. "WHO welcomes this
contribution from the vaccines industry and is also working with
countries to develop capacity for the production of influenza
vaccines. . . ."
To access the complete statement, go to:
http://www.who.int/mediacentre/news/statements/2007/s14/en/print.html
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11. |
HHS convenes leadership forum to help U.S. prepare for possible influenza
pandemic
On June 13, the Department of Health and Human
Services (HHS)
issued a press release titled "HHS Pandemic Leadership Forum
Mobilizes Employer, Faith-Based, Healthcare, And Civic Leaders:
America's leaders gather in Washington to help Americans prepare
for pandemic flu." Portions of the press release are reprinted
below.
The U.S. Department of Health and Human Services (HHS) today
assembled 100 influential leaders from the employer, faith-based, civic, and healthcare communities to participate in a
forum to help Americans become more prepared for an influenza
pandemic.
The Pandemic Influenza Leadership Forum is part of a new
national campaign sponsored by HHS to encourage people to
prepare for a possible pandemic. Using messages and materials
developed by HHS, leaders will provide the public with the
essential steps necessary for personal pandemic flu
preparedness. . . .
To access the complete press release, go to:
http://www.hhs.gov/news/press/2007pres/06/pr20070613a.html
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12. |
MMWR notifies readers that WHO will update the recommended nomenclature for
wild-type rubella viruses
CDC published "Notice to Readers: Update of
Recommended
Nomenclature for the Genetic Characteristics of Wild-Type
Rubella Viruses" in the June 15 issue of MMWR. A portion of the
notice is reprinted below.
The recommended nomenclature for wild-type rubella viruses is
being updated by the World Health Organization on June 15, 2007.
Wild-type rubella virus nomenclature was first published in 2005
to facilitate (1) communication among persons involved in
rubella control by establishing a standard naming convention for
rubella viruses and (2) virologic surveillance by defining
standard methods for the genetic characterization of these
viruses. Genetic characterizations of rubella viruses have
yielded data indicating that rubella is no longer endemic in the
United States and confirming epidemiologic information on the
source of imported cases. Results from genetic characterizations
of rubella viruses are periodically summarized in updates on the
global distribution of rubella virus genotypes. Genetic
characterization of rubella viruses is conducted by the World
Health Organization's measles and rubella laboratory network, a
network of approximately 700 laboratories worldwide, including
global specialized laboratories at the Health Protection Agency
in the United Kingdom, National Institute of Infectious Diseases
in Japan, and CDC in the United States. . . .
To access a web-text (HTML) version of the complete article, go
to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5623a4.htm
To access a ready-to-print (PDF) version of this issue of MMWR,
go to: http://www.cdc.gov/mmwr/PDF/wk/mm5623.pdf
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