Immunization Action Coalition and the Hepatitis B Coalition

IAC EXPRESS

Previous issues index

Home page

Issue Number 601            May 30, 2006

CONTENTS OF THIS ISSUE

  1. New: FDA licenses Zostavax, a vaccine to protect persons ages 60 years and older against varicella-zoster virus (shingles)
  2. IAC develops standing orders for administering child and adult vaccines and updates patient and professional immunization pieces
  3. Correction: Inaccurate information about government funding appeared in May 22 issue of IAC Express
  4. MMWR includes CDC's report on current multistate mumps outbreak
  5. Save the date: CDC's Immunization Update 2006 broadcast is scheduled for August 10
  6. Pandemic influenza: Possible human-to-human transmission of avian influenza reported in Indonesia; CDC releases May Pandemic Influenza Bulletin
  7. June 27 teleconference will recap news from the June 22 National Influenza Vaccine Summit
  8. Video webcast of NFID's May 18 media forum on evolving issues in the prevention and treatment of influenza available online
  9. Attention school nurses: Give It a Shot toolkit offers lots of time-saving resources for promoting teen immunization
  10. May 24 issue of Hep Express electronic newsletter now online
  11. Sixth Annual B Informed Patient Conference returning to San Francisco June 10–11

----------------------------------------------------------

Back to Top

---------------------------------------------------------------

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.
---------------------------------------------------------------

(1 of 11)
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
---------------------------------------------------------------

Back to Top

(2 of 11)
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)
  • Hepatitis B (Hep B)
  • Inactivated poliovirus (IPV)
  • Measles, mumps, rubella (MMR)
  • 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
-------------------------------------------------------------

Back to Top

(3 of 11)
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.
---------------------------------------------------------------

Back to Top

(4 of 11)
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
-------------------------------------------------------------

Back to Top

(5 of 11)
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
-------------------------------------------------------------

Back to Top

(6 of 11)
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. . . .

********************

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
-------------------------------------------------------------

Back to Top

(7 of 11)
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
-------------------------------------------------------------

Back to Top

(8 of 11)
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.
-------------------------------------------------------------

Back to Top

(9 of 11)
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.
---------------------------------------------------------------

Back to Top

(10 of 11)
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
---------------------------------------------------------------

Back to Top

(11 of 11)
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

 

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 May 30, 2006