Issue
Number 601
May 30, 2006
CONTENTS OF THIS ISSUE
- New: FDA licenses
Zostavax, a vaccine to protect persons ages 60 years and older against
varicella-zoster virus (shingles)
- IAC develops standing orders for
administering child and adult vaccines and updates patient and
professional immunization pieces
- Correction: Inaccurate information
about government funding appeared in May 22 issue of IAC Express
- MMWR includes CDC's report on current
multistate mumps outbreak
- Save the date: CDC's Immunization
Update 2006 broadcast is scheduled for August 10
- Pandemic influenza: Possible
human-to-human transmission of avian influenza reported in Indonesia; CDC
releases May Pandemic Influenza Bulletin
- June 27 teleconference will recap news
from the June 22 National Influenza Vaccine Summit
- Video webcast of NFID's May 18 media
forum on evolving issues in the prevention and treatment of influenza
available online
- Attention school nurses: Give It a
Shot toolkit offers lots of time-saving resources for promoting teen
immunization
- May 24 issue of Hep Express
electronic newsletter now online
- Sixth Annual B Informed Patient
Conference returning to San Francisco June 10–11
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ABBREVIATIONS: AAFP, American Academy of Family Physicians; AAP, American
Academy of Pediatrics; ACIP, Advisory Committee on Immunization Practices;
CDC, Centers for Disease Control and Prevention; FDA, Food and Drug
Administration; IAC, Immunization Action Coalition; MMWR, Morbidity and
Mortality Weekly Report; NIP, National Immunization Program; VIS, Vaccine
Information Statement; VPD, vaccine-preventable disease; WHO, World Health
Organization.
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May 30, 2006
NEW: FDA LICENSES ZOSTAVAX, A VACCINE TO PROTECT PERSONS AGES 60 YEARS AND
OLDER AGAINST VARICELLA-ZOSTER VIRUS (SHINGLES)
On May 25, the Food and Drug Administration (FDA) approved Merck's Zostavax,
a lyophilized preparation of the Oka/Merck strain of live, attenuated
varicella-zoster virus (VZV). The vaccine is intended to be administered as
a single dose to persons ages 60 years and older for prevention of herpes
zoster (shingles).
On May 26, FDA issued a press release announcing the approval. It is
reprinted below in its entirety.
************************
For immediate release
May 26, 2006
FDA LICENSES NEW VACCINE TO REDUCE OLDER AMERICANS' RISK OF SHINGLES
The Food and Drug Administration (FDA) licensed Zostavax, on May 25, 2006, a
new vaccine to reduce the risk of shingles (herpes zoster) for use in people
60 years of age and older.
Shingles is a disease caused by the varicella-zoster virus, the same virus
that causes chickenpox. After an attack of chickenpox, the virus lies
dormant in certain nerve tissue. As people age, it is possible for the virus
to reappear in the form of shingles, which is estimated to affect 2 in every
10 people in their lifetime. Shingles is characterized by clusters of
blisters, which develop on one side of the body and can cause severe pain
that may last for weeks, months, or years after the virus reappears.
"This vaccine gives health care providers an important tool that can help
prevent an illness that affects many older Americans and often results in
significant chronic pain," said Jesse L. Goodman, MD, MPH, director of FDA's
Center for Biologics Evaluation and Research.
Zostavax, a live virus vaccine, was shown to boost immunity against
varicella-zoster virus. This is thought to be the mechanism by which the
vaccine protects against zoster and its complications. The vaccine is given
as a single injection under the skin, preferably in the upper arm.
Zostavax was studied in approximately 38,000 individuals throughout the
United States who were 60 years of age and older. Of these 38,000 people,
half received Zostavax and half received a placebo. All study participants
were then followed for an average of three years to see if they developed
shingles and, if they did, how long the pain lasted.
At the conclusion of the study, researchers found that, overall, in those
ages 60 and above the vaccine reduced the occurrence of shingles by about
50%. For individuals ages 60-69 it reduced occurrence by 64%.
In addition to preventing approximately half of the cases, the duration of
pain following the onset of shingles was slightly reduced in people who
developed the disease—despite being vaccinated with Zostavax.
The most common side effects in people who received Zostavax were redness,
pain and tenderness, swelling at the site of injection, itching, and
headache. The percent of significant adverse events observed in the study
were not different between persons who received the vaccine versus placebo.
As part of the development program, a smaller study was conducted to look
more closely at safety. In this smaller study, serious adverse events for
all age groups were noted more frequently in those who received Zostavax
(1.9%) than those who received placebo (1.3%). Although FDA has concluded
that the available data do not establish that these events are related to
the vaccine, the manufacturer will perform a Phase 4 (postmarket) study to
provide additional safety information.
Zostavax is manufactured by Merck & Co., Inc., of Whitehouse Station, New
Jersey.
************************
To access the press release, go to:
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01378.html
To read questions and answers about the disease and the vaccine, go to:
http://www.fda.gov/cber/products/zosmer052506qa.htm
To read the package insert, go to:
http://www.fda.gov/cber/label/zosmer052506LB.pdf
To read the FDA approval information, go to:
http://www.fda.gov/cber/products/zosmer052506.htm
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May 30, 2006
IAC DEVELOPS STANDING ORDERS FOR ADMINISTERING CHILD AND ADULT VACCINES AND
UPDATES PATIENT AND PROFESSIONAL IMMUNIZATION PIECES
STANDING ORDERS PROTOCOLS
In May, IAC developed and posted on its website standing orders protocols
for vaccinating children and teens with the following vaccines:
-
Haemophilus influenzae type b (Hib)
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Hepatitis B (Hep B)
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Inactivated poliovirus (IPV)
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Measles, mumps, rubella (MMR)
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Meningococcal conjugate (MCV4) and meningococcal polysaccharide (MPSV4)
-
Pneumococcal conjugate (PCV)
-
Pneumococcal polysaccharide (PPV)
-
Varicella (Chickenpox)
Also in May, IAC developed and posted on its website a standing orders
protocol for vaccinating adults with the following vaccines:
-
Meningococcal conjugate (MCV4) and meningococcal polysaccharide (MPSV4)
To access these standing orders protocols and others developed and posted
before May, go to IAC's new web page where all standing orders are
available. Be sure to bookmark this page:
http://www.immunize.org/standingorders
PATIENT AND PROFESSIONAL IMMUNIZATION PIECES
In May, IAC updated its 1-page patient-education piece What Would Happen if
we Stopped Vaccinations? The piece now reflects 2004 data.
To access a ready-to-print (PDF) version of the updated piece, go to:
http://www.immunize.org/catg.d/4037stop.pdf
To access a web-text (HTML) version, go to:
http://www.immunize.org/catg.d/4037stop.htm
Also in May, IAC updated its 4-page professional-education piece Vaccine
Administration Record for Children and Teens. The piece now has space for
the new rotavirus vaccine; minor changes were also made.
To access a ready-to-print (PDF) version of the updated piece, go to:
http://www.immunize.org/catg.d/p2022b.pdf
To access a web-text (HTML) version, go to:
http://www.immunize.org/catg.d/p2022b.htm
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May 30, 2006
CORRECTION: INACCURATE INFORMATION ABOUT GOVERNMENT FUNDING APPEARED IN
MAY 22 ISSUE OF IAC EXPRESS
The footer on the email version of the May 22 issue of IAC Express
(issue #600) included erroneous information about the issue's funding
source. The footer erroneously stated that the production of the issue
was funded by two grants from CDC. In fact, no government funding was
used in producing the May 22 issue.
The footer should have read as follows:
"No part of this issue of IAC Express was produced using government
funds. The views expressed here are those of the Immunization Action
Coalition and do not represent the official views of any government
agency, including agencies of the federal government."
IAC regrets the error and any inconvenience it may have caused the
readers of IAC Express.
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May 30, 2006
MMWR INCLUDES CDC'S REPORT ON CURRENT MULTISTATE MUMPS OUTBREAK
CDC published "Update: Multistate outbreak of mumps—United States,
January 1–May 2, 2006" in the May 26 MMWR. Previously, the article was
available in electronic format as an MMWR Dispatch.
To access a web-text (HTML) version of the MMWR article, go to:
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5520a4.htm
To access a ready-to-print (PDF) version of this issue of MMWR, go to:
http://www.cdc.gov/mmwr/PDF/wk/mm5520.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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May 30, 2006
SAVE THE DATE: CDC'S IMMUNIZATION UPDATE 2006 BROADCAST IS SCHEDULED FOR
AUGUST 10
The live satellite broadcast and webcast Immunization Update 2006 will
provide up-to-date information on the rapidly changing field of
immunization. Following is the anticipated course content: influenza
vaccine, pertussis vaccine for adolescents and adults, revised
recommendations for childhood hepatitis A vaccination, the new vaccines
for rotavirus and herpes zoster, and possibly information about human
papillomavirus (HPV) vaccine.
Sponsored by CDC, the live broadcast is scheduled for August 10, from
9AM to 11:30AM ET. It will be rebroadcast later in the day from noon to
2:30PM ET. Both broadcasts will feature a live Q&A session in which
participants nationwide can interact with the course instructors by
toll-free telephone lines.
The course instructors are William L. Atkinson, MD, MPH; Donna Weaver,
RN, MN; and Andrew Kroger, MD, MPH. All are with the CDC's National
Immunization Program.
For comprehensive program information, go to:
http://www.phppo.cdc.gov/PHTN/immup-2006/default.asp or email
nipinfo@cdc.gov
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May 30, 2006
PANDEMIC INFLUENZA: POSSIBLE HUMAN-TO-HUMAN TRANSMISSION OF AVIAN INFLUENZA
REPORTED IN INDONESIA; CDC RELEASES MAY PANDEMIC INFLUENZA BULLETIN
On May 25, the federal government's Pandemic Influenza website (www.pandemicflu.gov)
posted an update on the current avian influenza situation in Indonesia, and
IAC posted CDC's Pandemic Influenza Update for May.
AVIAN INFLUENZA
Portions of the update on the current avian influenza situation in Indonesia
are reprinted below.
********************
There is an ongoing WHO investigation into a family cluster of H5N1-infected
persons in Indonesia. According to the latest information from WHO, 8
members of the family have contracted avian influenza, 7 have died, and 1
has survived.
A WHO team, including one of our foremost CDC influenza experts, is on-site
and collaborating with the Indonesian Ministry of Health on this
investigation. At this time, limited human-to-human transmission has not
been established definitively, but it is the leading hypothesis. If true, it
would be consistent with findings for earlier clusters in Hong Kong and
Thailand.
However, genetic analyses by WHO reference laboratories at CDC and the
University of Hong Kong indicate no evidence to date of evolution in the
virus that would enhance its transmissibility between humans. There are no
changes in the virus in Indonesia compared with other H5N1 viruses isolated
recently. . . .
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To access the complete update, go to:
http://www.pandemicflu.gov/news/indonesiaupdate.html
For information on the situation from the WHO website, go to:
http://www.who.int/csr/don/2006_05_23/en
PANDEMIC INFLUENZA BULLETIN
To access the May issue of CDC's Pandemic Influenza Bulletin, go to:
http://www.immunize.org/pandemic/panflu506.pdf
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May 30, 2006
JUNE 27 TELECONFERENCE WILL RECAP NEWS FROM THE JUNE 22 NATIONAL INFLUENZA
VACCINE SUMMIT
The National Immunization Coalition TA [technical assistance] Network has
scheduled a teleconference that will focus on issues discussed at the June
22 meeting of the National Influenza Vaccine Summit. It will be held at
1:00PM, ET, June 27.
The June 27 presenter is L.J. Tan, PhD, director of infectious diseases,
American Medical Association. Dr. Tan, co-founder and co-chair of the
summit, has served or currently serves on various expert panels on
immunization, including ACIP and ACIP's Adult Immunization Working Group and
Influenza Working Group.
To register for the teleconference, send an email to
IZTA@aed.org Include this message as the
subject of the email: "Sign me up for the Flu Summit Update."
For additional information, or to access earlier programs, go to:
http://www.izcoalitionsta.org/confcall.cfm
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May 30, 2006
VIDEO WEBCAST OF NFID'S MAY 18 MEDIA FORUM ON EVOLVING ISSUES IN THE
PREVENTION AND TREATMENT OF INFLUENZA AVAILABLE ONLINE
On May 18, the National Foundation for Infectious Diseases (NFID)
collaborated with several partner organizations in a forum for the news
media about the current challenges and issues relating to influenza
prevention and treatment. National experts from the following government
agencies and professional organizations participated in the forum:
-
Department of Health and Human Services
-
Centers for Disease Control and Prevention
-
Food and Drug Administration
-
National Vaccine Program Office
-
National Institute of Allergy and Infectious Diseases/National
Institutes of Health
-
American Medical Association
-
American Academy of Pediatrics
To access an archived video webcast of the forum from the NFID website, go
to: http://64.242.251.241 Registration,
which is free, is required; to register, scroll down the left column and
click on Register Now to Access Materials.
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May 30, 2006
ATTENTION SCHOOL NURSES: GIVE IT A SHOT TOOLKIT OFFERS LOTS OF TIME-SAVING
RESOURCES FOR PROMOTING TEEN IMMUNIZATION
The website of the American School Health Association recently posted
information about its publication "Give It a Shot: Toolkit for Nurses and
Other Immunization Champions Working with Secondary Schools."
It includes a 62-page manual of current information on adolescent
immunizations, a CD containing many of the handouts described in the manual,
and a DVD with a video for parents, "Vaccines: Separating Fact from Fear,"
and one for teens, "The Case of the Missing Shots."
The toolkit is available to ASHA members for $19.95 and to non-members for
$24.95. Bulk discounts are also available. For moreinformation and to order
the toolkit online, go to:
http://www.ashaweb.org Click on Bookstore in the horizontal menu at the
top of the page. Follow instructions from there.
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May 30, 2006
MAY 24 ISSUE OF HEP EXPRESS ELECTRONIC NEWSLETTER NOW ONLINE
The May 24 issue of Hep Express, an electronic newsletter published by
IAC, is now available online. It is intended for health and social
service professionals involved in the prevention and treatment of
viral hepatitis.
Two articles in the May 24 issue are of particular note; these are
their titles:
-
Viral hepatitis is the focus of the May issue of NASTAD's HIV
Prevention Bulletin
-
Presentations from March international meeting on perinatal HBV
[hepatitis B virus] transmission are available online
Titles of additional articles from the May 24 Hep Express include the
following:
-
Briefing on Hepatitis B Bill HR 4550 held in Washington, DC
-
A worthwhile publication: SIGNpost will keep you up to date on
global injection-safety issues
-
Webcast coming June 6–7 on epidemiology and prevention of
perinatal hepatitis B and C
-
Twelfth International Symposium on Viral Hepatitis and Liver
Disease to be held in Paris July 1–5
To access the May 24 issue, go to:
http://www.hepprograms.org/hepexpress/issue44.asp
To sign up for a free subscription to Hep Express, go to:
http://www.hepprograms.org/hepexpress/signup.asp
To access previous issues of Hep Express, go to:
http://www.hepprograms.org/hepexpress
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May 30, 2006
SIXTH ANNUAL B INFORMED PATIENT CONFERENCE RETURNING TO SAN
FRANCISCO JUNE 10–11
[The following is cross posted from IAC's Hep Express electronic
newsletter, 5/24/06.]
The Hepatitis B Foundation's Sixth Annual B Informed Patient
Conference will return to San Francisco on June 10–11. Patients,
as well as their families and loved ones, are invited to
participate in this lively two-day discussion focusing on the care
and management of chronic hepatitis B. There will be presentations
in both Chinese and English.
Registration information is available at
http://www.hepb.org/patients/patient_conference2006.htm |
