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Immunization Action Coalition
IAC Express 2007
Issue number 670: June 18, 2007
 
Contents of this Issue
Select a title to jump to the article.
  1. FDA approves revised label for RotaTeq; CDC provides information about the change
  2. New: July 2007 issue of Vaccinate Women is on the IAC website
  3. IAC introduces new pieces that answer patients' questions about tetanus, rubella, polio, meningococcal, and rotavirus
  4. June issue of CDC's Immunization Works electronic newsletter now available online
  5. Current Issues in Immunization net conference to focus on immunizations for healthcare personnel--registration is limited
  6. Mark your calendar: August 9 is the date for CDC's live satellite broadcast "Immunization Update 2007"
  7. New VIS translation: VIS for DTaP vaccine now available in Turkish
  8. Former CDC director writes about changes in public health from 1993-1998
  9. HHS awards two contracts to expand domestic influenza vaccine manufacturing capacity
  10. WHO and vaccine manufacturers to continue progress on plan to create global stockpile of H5N1 avian influenza vaccine
  11. HHS convenes leadership forum to help U.S. prepare for possible influenza pandemic
  12. MMWR notifies readers that WHO will update the recommended nomenclature for wild-type rubella viruses
 
Abbreviations
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.
  
Issue 670: June 18, 2007
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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This website is supported in part by a cooperative agreement from the National Center for Immunization and Respiratory Diseases (Grant No. 5U38IP000290) at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. The website content is the sole responsibility of IAC and does not necessarily represent the official views of CDC.