Immunization Action Coalition and the Hepatitis B Coalition

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Issue Number 591            April 10, 2006

CONTENTS OF THIS ISSUE

  1. IAC posts three thimerosal resources to its website
  2. CDC issues an update on Guillain-Barre Syndrome and receipt of Menactra vaccine
  3. Handouts and recordings of NIC sessions now available online
  4. April issue of Immunization Works summarizes information about NIP reorganization and name change
  5. New: April issue of CDC's Immunization Works electronic newsletter now available online
  6. MMWR publishes report on the current mumps epidemic in Iowa
  7. Avian influenza covered extensively on the websites of CDC, NIAID, and WHO
  8. Reminder: Register soon for the April 20 Rotavirus net conference
  9. Public Health and the Law in the 21st Century conference scheduled for June 12-14 in Atlanta

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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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April 10, 2006
IAC POSTS THREE THIMEROSAL RESOURCES TO ITS WEBSITE

IAC recently added three resources to the homepage of its website at http://www.immunize.org Links to these resources are in the upper right corner of the homepage.

The first is a joint letter to the U.S. Congress signed by 22 national organizations that oppose legislative efforts to restrict access to vaccines that contain thimerosal. To access the letter, go to: http://www.immunize.org/thimerosalletter.pdf

The second is a summary for parents of the evidence explaining that thimerosal is not a cause of autism. It was written by Paul A. Offit, MD. An immunization expert, Dr. Offit is chief, Division of Infectious Diseases, Children's Hospital of Philadelphia, and professor of pediatrics and Maurice R. Hilleman Professor of Vaccinology, University of Pennsylvania School of Medicine. To access the summary, go to: http://www.immunize.org/catg.d/p2066.pdf

The third is a press release CDC issued in response to an advertisement attacking CDC that appeared in the April 6 issue of USA Today. Titled "CDC statement regarding autism-related advertisement in USA Today," the press release states the ad "mischaracterizes the efforts of CDC, the American Academy of Pediatrics, the Institute of Medicine, and others to protect the health and well-being of the nation's children." To access the press release, go to: http://www.cdc.gov/od/oc/media/pressrel/s060406.htm
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April 10, 2006
CDC ISSUES AN UPDATE ON GUILLAIN-BARRE SYNDROME AND RECEIPT OF MENACTRA VACCINE

CDC published "Update: Guillain-Barre Syndrome Among Recipients of Menactra Meningococcal Conjugate Vaccine—United States, October 2005–February 2006" in the April 7 issue of MMWR. Portions of the article are reprinted below.

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In October 2005, a possible association between Guillain-Barre Syndrome (GBS) and receipt of meningococcal conjugate vaccine (i.e., meningococcal polysaccharide diphtheria toxoid conjugate vaccine [Menactra])(MCV4) was reported. GBS is a serious neurologic disorder involving inflammatory demyelination of the peripheral nerves. At the time of the first report, five confirmed cases of GBS after receipt of MCV4 had been reported to the Vaccine Adverse Events Reporting System (VAERS). During the 4 months since, three additional confirmed cases of GBS have been reported. This report describes two of these recent cases and provides additional data collected through February 2006. Because available evidence neither proves nor disproves a causal relation between MCV4 and GBS, further monitoring and studies are ongoing within VAERS and the Vaccine Safety Datalink (VSD). CDC continues to recommend use of MCV4 for persons for whom vaccination is indicated; the additional reported cases have not resulted in any change to that recommendation.

Case Reports
Brief clinical and epidemiologic descriptions of two of the newly reported cases follow. The third case is undergoing detailed clinical investigation but meets the provisional case definition for GBS.

Case 1. On August 8, 2005, a male aged 19 years from Arizona was vaccinated with MCV4. Approximately 25 days later, he experienced numbness and tingling in his hands and feet, followed by weakness in his legs, difficulty running, and decreased dexterity in his hands. In the month before neurologic symptom onset, he had no defined episode of respiratory or gastrointestinal illness. He had traveled to Mexico twice during the preceding 3 months. Electrophysiology studies revealed a diffuse neuropathic process with both demyelinating and axonal features, consistent with GBS. Testing for Epstein-Barr virus capsid IgG and IgM antibodies was negative. Testing for cytomegalovirus IgG and IgM antibodies also was negative, as were serologic studies for hepatitis A, B, and C to rule out other probable causes of GBS. The patient was treated with intravenous immunoglobulin. At follow-up examination 8 weeks after onset, he had fully recovered.

Case 2. On November 4, 2005, a male aged 17 years from Ohio received MCV4. Eleven days later, he experienced numbness and tingling in his right foot, followed by the same symptoms in the left foot, which progressed proximally during the next 5 days. He also described a neck hyperextension injury sustained while playing sports 2 days before the start of sensory symptoms and sore throat and congestion 1 day before sensory symptoms. He had no gastrointestinal illness during the 6 weeks before hospital admission, which occurred 6 days after symptom onset. Cervical spine radiographs revealed no fractures; magnetic resonance imaging (MRI) of the spine revealed mild enhancement along the surface of distal cord and lumbar nerve roots, consistent with GBS. Nerve conduction studies also were consistent with GBS. Polymerase chain reaction (PCR) assays for enterovirus were negative, as were tests for Mycoplasma pneumoniae IgG and IgM. The patient was treated with intravenous immunoglobulin. At follow-up examination 2 weeks after admission, he had completely recovered.

In the two cases described in this report, the period from MCV4 vaccination to symptom onset was less than 6 weeks. This is the time window of elevated risk noted for GBS after administration of certain other vaccines.

To determine whether the reporting rate of GBS after MCV4 vaccination was higher than the expected incidence rate of GBS for the appropriate age group population, the reporting rate was calculated by dividing the eight confirmed GBS cases with onset within 6 weeks of vaccination by the number of vaccine doses distributed as provided by the manufacturer (approximately 3.77 million doses of MCV4 were distributed during March 2005–February 2006). The eight cases were divided by the 3.77 million  distributed doses to provide the reporting rate for GBS after MCV4. The expected incidence rate of GBS was estimated from a multistate hospital discharge database (Health Care Utilization Project). For the years 2000–2003, the incidence rate of GBS among persons aged 11–19 years was estimated to be 1.4 per 100,000 population per year or 0.17 per 100,000 population during a 6-week period. Therefore, the ratio of the reporting rate of GBS after MCV4 vaccination to the expected incidence rate was 1.4 (95% confidence interval = 0.7–2.8), suggesting that the occurrence of eight cases of GBS within 6 weeks of MCV4 administration is similar to what might be expected to occur by chance alone. . . .

Editorial Note:
In October 2005, CDC and the Food and Drug Administration (FDA) alerted healthcare providers about a possible association between GBS and MCV4 and encouraged reporting of adverse events to VAERS. Since that time, three additional confirmed cases of GBS with onset within 6 weeks of MCV4 vaccination have been reported. However, even with these reported cases, the reported incidence remains similar to the expected incidence. In addition, three other cases of GBS have been reported, with symptom onsets at [more than] 6 weeks (107 days, 116 days, and 125 days) after vaccination with MCV4; these three cases were not included in calculation of GBS rates. Because VAERS is a voluntary reporting system, the completeness of reporting of GBS remains unknown. Only three cases were reported since October 2005, suggesting that MCV4 might not be causally related to GBS. The background incidence rate of GBS is one to two cases per 100,000 population. However, the timing of onset of neurologic symptoms within 2–5 weeks of vaccination is still a concern.

Additional preliminary data from VSD, a collaborative project between CDC and eight managed care organizations in the United States, have not identified GBS cases in MCV4 recipients. However, VSD has a limited ability to detect rare health events such as GBS. To further evaluate any potential risk, additional controlled studies of GBS after MCV4 are being planned.

The case definition developed for the initial investigation has been refined by an extended working group of the Brighton Collaboration, an international voluntary collaboration of scientists. The Clinical Immunization Safety Assessment Network, in collaboration with CDC, continues to research and conduct standardized clinical evaluation of affected vaccinees to better understand the pathophysiology of select adverse events after vaccination, such as GBS. In response to the evaluation of the reported cases to VAERS, Sanofi Pasteur and FDA updated the Menactra vaccine package insert to list previous GBS as a contraindication and provide a warning of the temporal relation between GBS and MCV4.

In October 2005, CDC recommended continuing use of MCV4 for persons for whom vaccination is recommended; the additional cases reported in this update do not affect that recommendation. In December 2005, the Global Advisory Committee on Vaccine Safety also recommended no change in MCV4 vaccination policies.

The Advisory Committee on Immunization Practices has recommended that persons with a history of GBS should not be vaccinated with MCV4 unless they are at elevated risk for meningococcal disease.  Persons at elevated risk for meningococcal disease include first-year college students living in dormitories, military recruits, travelers to areas in which meningococcal disease is hyperendemic or epidemic, microbiologists who are routinely exposed to isolates of Neisseria meningitidis, patients with anatomic or functional asplenia, and patients with terminal complement deficiency. Information regarding the current investigation should be shared with adolescents and caregivers before MCV4 vaccination. A Vaccine Information Statement and fact sheet noting the information on the reported GBS cases is available at http://www.cdc.gov/nip/publications/vis/default.htm An updated fact sheet for healthcare workers is available at http://www.cdc.gov/nip/vacsafe/concerns/gbs/menactra.htm CDC continues to recommend that healthcare workers and any other persons aware of adverse events associated with MCV4 or any other vaccination report to VAERS cases of GBS or any other clinically significant adverse events. Reports may be submitted securely online at http://www.vaers.hhs.gov or by fax at (877) 721-0366. Reporting forms and additional information [are] available [by] telephone, (800) 822-7967.

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To access a web-text (HTML) version of the complete article, go to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5513a2.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5513.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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April 10, 2006
HANDOUTS AND RECORDINGS OF NIC SESSIONS NOW AVAILABLE ONLINE

[The following is cross posted with thanks from the April 2006 issue of CDC's Immunization Works electronic newsletter. It is a portion of the article titled "Record Attendance at 40th NIC." To access the complete article, go to: http://www.cdc.gov/nip/news/newsltrs/imwrks/2006/200604.htm#other]

Handouts and audio/video recordings from the 40th NIC are now available online. To obtain handouts and audio/video recordings, please visit the NIC website http://www.cdc.gov/nip/NIC, scroll down to "Conference Recordings and Slides," and click "Go." Handouts and audio/video recordings can be accessed by searching with key words or by scrolling through the NIC program and selecting a specific plenary or workshop session. If available, the audio and/or handout for a specific presentation can then be selected. Also, conference participants can receive Continuing Education (CE) credits for participation until April 13, 2006. Please visit http://www.cdc.gov/nip/NIC/40th/cestatements.htm for CE information. . . .

[IAC editor's note: Following are direct links to recordings of three notable presentations:

"Maurice Hilleman: His Extraordinary Life and Work," the Jeryl Lynn Hilleman Endowed Lecture delivered by Paul A. Offit, MD, chief, Division of Infectious Diseases, Children's Hospital of Philadelphia, and professor of pediatrics and Maurice R. Hilleman Professor of Vaccinology, University of Pennsylvania School of Medicine. To access this presentation, go to: http://cdc.confex.com/cdc/nic2006/techprogram/P12005.HTM

"Fifteen Years of Successful Immunization Partnerships, the Successes and the Challenges that Remain," a speech at the closing plenary session delivered by Rosalynn Carter, former First Lady of the United States. To access this presentation, go to: http://cdc.confex.com/cdc/nic2006/techprogram/P12037.HTM

"Fifteen Years of Successful Immunization Partnerships, the Successes and the Challenges that Remain: Comments," a speech at the closing plenary session delivered by Betty Bumpers, former First Lady of Arkansas. To access this presentation, go to: http://cdc.confex.com/cdc/nic2006/techprogram/P11758.HTM]
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April 10, 2006
APRIL ISSUE OF IMMUNIZATION WORKS SUMMARIZES INFORMATION ABOUT NIP REORGANIZATION AND NAME CHANGE

[The following is cross posted with thanks from the April 2006 issue of CDC's Immunization Works electronic newsletter.]

NIP HAS NEW NAME, NEW MISSION
In April 2006, the National Immunization Program (NIP) will become the proposed National Center for Immunization and Respiratory Diseases (NCIRD), to be housed in CDC's Coordinating Center for Infectious Diseases (CCID). NCIRD will be led by Anne Schuchat, MD, who currently serves as NIP's Director. NCIRD's proposed mission will be to prevent disease, disability, and death through immunization and by control of respiratory and related diseases. The new center will support both domestic and global immunization and respiratory disease prevention and control priorities, and will link epidemiology and laboratory science around vaccine-preventable diseases and acute respiratory infections with prevention and control programs and strong communication science.

As shown here (http://www.cdc.gov/nip/webutil/about/divisions/NCIRDorg.htm), NCIRD will contain five divisions:

  1. Immunization Services Division (ISD)
  2. Global Immunization Division (GID)
  3. Division of Bacterial Diseases (DBD)
  4. Division of Viral Diseases (DVD)
  5. Influenza Division (ID)

ISD and GID will retain similar structures and functions in NCIRD as they had in NIP. Functions from NIP's Epidemiology and Surveillance Division (ESD) will be relocated into NCIRD's three new divisions: ID, DVD, and DBD.

NCIRD will strive to work closely with partners to provide a key focus for vaccine-preventable disease and immunization program issues. NCIRD will also work within CDC to synthesize vaccine-related information from other parts of CDC with immunization expertise.

NCIRD will not be responsible for all vaccine-preventable disease functions nor all respiratory infectious disease functions. For example, the Division of Viral Hepatitis (DVH)— which is now part of CDC's National Center for Infectious Diseases (NCID)— will be moved into the National Center for HIV, Viral Hepatitis, STDs, and Tuberculosis Prevention (NCHHSTP). Like NCIRD, NCHHSTP will be housed in CDC's Coordinating Center for Infectious Diseases (CCID). DVH will have primary responsibilities concerning hepatitis A and hepatitis B, and will retain subject matter experts for these diseases. However, DVH will work in collaboration with ISD to provide program support to state immunization partners on issues concerning hepatitis A and hepatitis B.

As always, working with partners will remain a high priority for immunization staff at CDC. Future updates about NCIRD and other CDC organizational changes will continue to be shared with immunization partners through this publication.
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April 10, 2006
NEW: APRIL ISSUE OF CDC'S IMMUNIZATION WORKS ELECTRONIC NEWSLETTER NOW AVAILABLE ONLINE

The April issue of Immunization Works, a monthly email newsletter published by CDC, is available on NIP's website. 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 April issue has already appeared in previous issues of IAC Express or is covered separately in this issue. Following is the text of two articles we have not covered.

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Meetings, Conferences, and Resources
NIP 2006 ANNUAL REPORT: The 2006 National Immunization Program (NIP) Annual Report, entitled A Global Commitment to Lifelong Protection through Immunization, has been posted to the CDC website. The report can be viewed or printed from http://www.cdc.gov/nip/webutil/about/annual-rpts/ar2006/2006annual-rpt.htm A hard copy of the report can be ordered from the NIP Immunization Educational and Training Materials order form, which can be found at https://www2.cdc.gov/nchstp_od/PIWeb/niporderform.asp The 2006 NIP Annual Report is listed under "Publications for Healthcare Providers."

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CDC NEEDS PILOT TESTERS: CDC has an ongoing need for volunteers to pilot test immunization training courses. Volunteers are particularly needed in the following occupations: physicians, pharmacists, health educators, medical assistants, and nurses. To learn more about becoming a pilot tester, please send an email to nippilot@cdc.gov

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To access the complete April issue from the NIP website, go to:
http://www.cdc.gov/nip/news/newsltrs/imwrks/2006/200604.htm
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April 10, 2006
MMWR PUBLISHES REPORT ON THE CURRENT MUMPS EPIDEMIC IN IOWA

CDC published "Mumps Epidemic—Iowa, 2006" in the April 7 issue of MMWR. Previously, the article was available only 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/mm5513a3.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5513.pdf
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April 10, 2006
AVIAN INFLUENZA COVERED EXTENSIVELY ON THE WEBSITES OF CDC, NIAID, AND WHO

Recently, CDC, NIAID (National Institute of Allergy and Infectious Diseases), and WHO have updated their websites with information pertinent to the current worldwide avian influenza situation.

1. CDC
CDC posted new information to its Influenza web section about the status of human cases reported in Egypt and animal cases reported in the United Kingdom and Czech Republic.

New
* Avian influenza update: Egypt (posted 4/4/06)

To access this resource, go to: http://www.cdc.gov/flu/whatsnew.htm#new and click on the pertinent link.

Updated
* Avian influenza: Current Situation [United Kingdom] (posted 4/7/06)
* Questions & answers about avian influenza (bird flu) & avian influenza virus (posted 4/7/06)
* Recommendations for using antiviral agents for influenza (posted 4/4/06)
* Avian influenza: Current situation [Czech Republic] (posted 4/4/06)
* Avian influenza: Current situation [Egypt] (posted 4/3/06)

To access these resources, go to: http://www.cdc.gov/flu/whatsnew.htm#updated and click on the pertinent links.

To access a broad range of continually updated information on seasonal influenza, avian influenza, and pandemic influenza, go to: http://www.cdc.gov/flu

2. NIAID
On March 29, NIAID issued a press release, "H5N1 avian flu virus vaccine induces immune responses in healthy adults." To access the press release, go to: http://www3.niaid.nih.gov/news/newsreleases/2006/avianvax3_06.htm

3. WHO
The April 7 issue of the WHO publication Weekly Epidemiological Record included a comprehensive article titled "Avian influenza fact sheet." The article discusses the following: (1) the disease in birds, (2) the role of migratory birds, (3) countries affected by outbreaks in birds, (4) the disease in humans, and (5) countries with human cases in the current outbreak. To access the April 7 issue, go to: http://www.who.int/wer/2006/wer8114/en/index.html
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April 10, 2006
REMINDER: REGISTER SOON FOR THE APRIL 20 ROTAVIRUS NET CONFERENCE

[The following is cross posted with thanks from the April 2006 issue of CDC's Immunization Works electronic newsletter.]

ROTAVIRUS NET CONFERENCE: CDC will present a live net conference on April 20 from noon to 1:00 PM ET concerning (1) rotavirus general recommendations (timing and spacing of immunobiologics and altered immunocompetence) and (2) rotavirus vaccine recommendations. Part of the Current Issues in Immunization series, this net conference is designed to provide clinicians with the most up-to-date information on immunization issues. It will combine a telephone audio conference and simultaneous online visual content, and participants can join the Q&A session by telephone or Internet. Instructions and system requirements can be found at http://www.cdc.gov/nip/ed/ciinc/instructions.htm Please note that space is limited, and registration is required. Registration will close when the course is full or on April 17 (midnight ET). To register, please visit http://www2.cdc.gov/nip/isd/ciinc
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April 10, 2006
PUBLIC HEALTH AND THE LAW IN THE 21ST CENTURY CONFERENCE SCHEDULED FOR JUNE 12-14 IN ATLANTA

Scheduled for June 12-14, the conference the Public Health and the Law in the 21st Century will be held in Atlanta. The conference will offer sessions on (1) legal preparedness for avian influenza and natural disasters and (2) the policy issues and legal frameworks surrounding vaccine safety.

The early-bird registration deadline is May 20. For comprehensive information on the conference, go to: http://www2a.cdc.gov/phlp/conference2006.asp

 

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 April 10, 2006