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Immunization Action Coalition
IAC Express 2007
Issue number 686: October 1, 2007
 
Contents of this Issue
Select a title to jump to the article.
  1. FDA approves Afluria, a new inactivated influenza vaccine for use in people age 18 years and older
  2. NEJM publishes three articles related to thimerosal in vaccines
  3. Interim VIS for hepatitis B vaccine now available in Spanish
  4. CDC reports on national and global influenza activity during May 20-September 15, 2007
  5. Proceedings from the June 27-28 ACIP meeting now online
  6. WHO's "World Health Report 2007" focuses on building a safer future through international public health cooperation
  7. Snap Shots, an electronic newsletter of USAID, offers readers an international perspective on immunization
  8. ICEID to be held in Atlanta on March 16-19, 2008; abstracts due November 19
  9. Vermont Department of Health schedules immunization conference for October 30 in Stowe, VT
  10. The journal Vaccine to celebrate its 25th anniversary at the Vaccine Congress in Amsterdam on December 9-11
  11. Seminar on infectious diseases modeling scheduled for December 10-12 in Annecy, France
  12. CDC publishes update on global activity of vaccine-derived polioviruses during January 2006-August 2007
 
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 686: October 1, 2007
1.  FDA approves Afluria, a new inactivated influenza vaccine for use in people age 18 years and older

On September 28, FDA issued a press release announcing its approval of Afluria (manufactured by CSL Limited), an inactivated influenza virus vaccine. It is indicated for active immunization of adults age 18 years and older against influenza disease caused by influenza virus type A and type B present in the vaccine. The press release is reprinted below in its entirety. Links to the approval letter and the package insert appear at the end of this IAC Express article.


ADDITIONAL INFLUENZA VACCINE APPROVED FOR UPCOMING INFLUENZA SEASON
Approval increases available doses to record level

The U.S. Food and Drug Administration today approved Afluria, an additional seasonal influenza vaccine for the immunization of people ages 18 and older.

Afluria is intended to protect adults from influenza type A and type B flu viruses. Influenza is a contagious respiratory illness that can cause annual epidemics.

The approval of Afluria, manufactured by CSL Limited of Parkville, Australia, brings the number of seasonal influenza manufacturers licensed for the U.S. market to six.

Based on current manufacturing trends, the Centers for Disease Control and Prevention estimates that the six manufacturers will supply a record 132 million doses of influenza vaccine for the 2007-2008 influenza season.

"Routine immunization is the most effective way to prevent influenza and decrease influenza-related complications which can include serious illness and death," said Jesse L. Goodman, MD, MPH, director of FDA's Center for Biologics Evaluation and Research. "The licensure of this additional manufacturer contributes to having an adequate supply of seasonal influenza vaccine for Americans, one of FDA's highest priorities."

Flu season in the United States can begin as early as October and can last as late as May, according to the CDC. Every year in the United States, more than 200,000 people are hospitalized with influenza and about 36,000 people die from its complications. While it is best to be immunized as soon as the vaccine is available, usually in September, getting a flu shot any time during influenza season is also appropriate because the influenza season often peaks late.

Afluria was approved using FDA's accelerated approval pathway for serious or life-threatening diseases, which reduces the time for needed medical products to become available to the public. In this case, the manufacturer demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza. As part of the accelerated approval process, the manufacturer will conduct further studies to verify that the vaccine decreases seasonal influenza disease after vaccination.

The most commonly reported adverse events were tenderness, pain, redness and swelling at the injection site, and headache, fatigue and muscle aches.

Afluria contains inactivated influenza viruses grown in chicken eggs. People who are allergic to eggs or any other component of the vaccine should not receive Afluria.

The vaccine is administered as a single injection in the upper arm, and is available in both a single-dose, preservative-free, pre-filled syringe and a multi-dose vial with thimerosal, a mercury derivative, as a preservative.


To access the press release, go to:
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01714.html

To access the approval letter, go to:
http://www.fda.gov/cber/approvltr/afluria092807L.htm

To access the package insert, go to:
http://www.fda.gov/cber/label/afluriaLB.pdf

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2 NEJM publishes three articles related to thimerosal in vaccines

In its September 27 issue, the New England Journal of Medicine (NEJM) published one research article and two editorials about thimerosal in childhood vaccines.

The research article is titled "Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years." The abstract is reprinted below; a link to the complete article is given at the end of this IAC Express article.

One of the editorials, "Thimerosal and Vaccines--A Cautionary Tale," is written by Paul A. Offit, MD. It provides essential background information on the thimerosal controversy, making it useful to those who communicate about vaccine safety issues. The other editorial, "Cases in Vaccine Court--Legal Battles over Vaccines and Autism," is written by Stephen D. Sugarman, JD. It comments on the legal processing of parents' claims that vaccination has caused their children's health problems. Links to both editorials are given at the end of this IAC Express article.

CDC and professional associations have posted information on their websites related to the findings in the research article. Links to those postings are given at the end of this IAC Express article.


ABSTRACT
Background: It has been hypothesized that early exposure to thimerosal, a mercury-containing preservative used in vaccines and immune globulin preparations, is associated with neuropsychological deficits in children.

Methods: We enrolled 1,047 children between the ages of 7 and 10 years and administered standardized tests assessing 42 neuropsychological outcomes. (We did not assess autism-spectrum disorders.) Exposure to mercury from thimerosal was determined from computerized immunization records, medical records, personal immunization records, and parent interviews. Information on potential confounding factors was obtained from the interviews and medical charts. We assessed the association between current neuropsychological performance and exposure to mercury during the prenatal period, the neonatal period (birth to 28 days), and the first 7 months of life.

Results: Among the 42 neuropsychological outcomes, we detected only a few significant associations with exposure to mercury from thimerosal. The detected associations were small and almost equally divided between positive and negative effects. Higher prenatal mercury exposure was associated with better performance on one measure of language and poorer performance on one measure of attention and executive functioning. Increasing levels of mercury exposure from birth to 7 months were associated with better performance on one measure of fine motor coordination and on one measure of attention and executive functioning. Increasing mercury exposure from birth to 28 days was associated with poorer performance on one measure of speech articulation and better performance on one measure of fine motor coordination.

Conclusions: Our study does not support a causal association between early exposure to mercury from thimerosal-containing vaccines and immune globulins and deficits in neuropsychological functioning at the age of 7 to 10 years.


To access the complete research article, go to:
http://content.nejm.org/cgi/content/short/357/13/1281

To access Paul A. Offit's editorial, go to:
http://content.nejm.org/cgi/content/full/357/13/1278

To access Stephen D. Sugarman's editorial, go to:
http://content.nejm.org/cgi/content/full/357/13/1275

To access a transcript of a CDC press briefing related to the research article, go to:
http://www.cdc.gov/od/oc/media/transcripts/2007/t070926.htm

To access a posting related to the research article from the website of the National Network for Immunization Information, go to:
http://www.immunizationinfo.org/immunization_science_detail.cfv?id=131

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3 Interim VIS for hepatitis B vaccine now available in Spanish

The current version of the interim VIS for hepatitis B vaccine, dated 7/18/07, is now available on the IAC website in Spanish. IAC gratefully acknowledges the California Department of Public Health, Immunization Branch, for the translation.

To obtain a ready-to-print (PDF) version of the interim VIS for hepatitis B vaccine in Spanish, go to:
http://www.immunize.org/vis/sphepb01.pdf

To obtain it in English, go to:
http://www.immunize.org/vis/hepb01.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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4 CDC reports on national and global influenza activity during May 20-September 15, 2007

CDC published "Update: Influenza Activity--United States and Worldwide, May 20-September 15, 2007" in the September 28 issue of MMWR. Portions of the article are reprinted below.


During May 20-September 15, 2007, influenza A (H1), influenza A (H3), and influenza B viruses co-circulated worldwide and were identified sporadically in the United States. This report summarizes influenza activity in the United States and worldwide since the last MMWR update. . . .

During May 20-September 15, data from the U.S. Influenza Sentinel Provider Surveillance System indicated that the weekly percentage of patient visits to U.S. sentinel providers for influenza-like illness (ILI) remained below the national baseline of 2.1% and ranged from 0.6% to 1.0%. The percentage of deaths attributed to pneumonia and influenza (P&I) as reported by the 122 Cities Mortality Reporting System was below the epidemic threshold. One influenza-associated pediatric death occurred during June and was reported to the Influenza-Associated Pediatric Mortality Reporting System.

Two human cases of novel influenza A were reported to the National Notifiable Diseases Surveillance System (NNDSS). Both persons were infected with swine influenza virus and were infected by handling ill pigs at a county fair in Ohio. Both recovered from their illness. . . .


To access a web-text (HTML) version of the complete article, go to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5638a4.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5638.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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5 Proceedings from the June 27-28 ACIP meeting now online

The CDC website recently posted the Record of the Proceedings of ACIP's June 27-28 meeting. To access a ready-to-print (PDF) version of the proceedings, go to:
http://www.cdc.gov/vaccines/recs/acip/downloads/min-jun07.pdf

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6 WHO's "World Health Report 2007" focuses on building a safer future through international public health cooperation

WHO's "World Health Report 2007--A safer future: global public health security in the 21st century" shows how the world is at increasing risk of disease outbreaks, epidemics, industrial accidents, natural disasters, and other health emergencies that can rapidly become threats to global public health security. The report explains how the revised International Health Regulations (2005), which came into force this year, helps countries work together to identify risks and act to contain and control them.

For additional information, including links to the complete report and to individual report chapters, go to:
http://www.who.int/whr/2007/en

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7 Snap Shots, an electronic newsletter of USAID, offers readers an international perspective on immunization

Snap Shots, an electronic publication of USAID's IMMUNIZATIONbasics Project, is intended to provide busy public health professionals with references and periodic updates from the immunization world. Although the primary audience for Snap Shots is USAID (U.S. Agency for International Development) health staff and staff of USAID-funded projects, other immunization professionals will find it an excellent way to gain an international perspective on immunization.

To access the current and back issues of Snap Shot, go to:
http://www.immunizationbasics.jsi.com/Newsletter/SnapShotsArchive.htm

To subscribe, go to:
http://www.immunizationbasics.jsi.com/Newsletter/Subscribe.htm

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8 ICEID to be held in Atlanta on March 16-19, 2008; abstracts due November 19

The International Conference on Emerging Infectious Diseases (ICEID) is scheduled for March 16-19, 2008, in Atlanta. ICEID brings together public health professionals to encourage the exchange of scientific and public health information on global emerging infectious disease issues.

Abstracts must be submitted electronically by November 19, 2007. For more information about abstract submission, go to: http://www.iceid.org/abstracts-cfa.asp

For a comprehensive overview of the conference, go to: http://www.iceid.org or contact iceid@asmusa.org or (202) 942-9330.

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9 Vermont Department of Health schedules immunization conference for October 30 in Stowe, VT

This one-day conference is intended for Vermont healthcare professionals involved in any aspect of immunization, including education, compliance, and administration. The keynote speaker is Andrew Kroger, MD, MPH, of CDC's National Center for Immunization and Respiratory Diseases.

To download the conference brochure, which includes a registration form, go to:
http://healthvermont.gov/documents/103007conferencebrochure.pdf

For additional information, contact Miriam Sheehey, RN VFC, at (802) 865-7755 or msheehe@vdh.state.vt.us

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10.  The journal Vaccine to celebrate its 25th anniversary at the Vaccine Congress in Amsterdam on December 9-11

The journal Vaccine will celebrate its 25th anniversary at the first Vaccine Congress, which will be held in Amsterdam on December 9-11.

For complete details, including links to program and registration information, go to: http://www.vaccinecongress.com

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11.  Seminar on infectious diseases modeling scheduled for December 10-12 in Annecy, France

A seminar on infectious disease modeling is planned for December 10-12 at Les Pensieres Conference Center, Annecy, France. The program will be conducted in English.

To access the seminar program and registration form, go to: http://www.fondation-merieux.org/en/knowledge/conferences/conferences.php Scroll down and click on the pertinent link(s) in the section titled "Advances in modelisation for infectious diseases."

For additional information, email Catherine Dutel at catherine.dutel@fondation-merieux.org

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12.  CDC publishes update on global activity of vaccine-derived polioviruses during January 2006-August 2007

CDC published "Update on Vaccine-Derived Polioviruses--Worldwide, January 2006-August 2007" in the September 28 issue of MMWR. Portions of an article synopsis made available to the press are reprinted below.


Vaccine-derived polioviruses (VDPVs), fall into three categories: (1) circulating VDPVs (cVDPVs) from outbreaks, (2) primary immunodeficiency-associated VDPVs (iVDPVs) from patients with defects in antibody production, and (3) ambiguous VDPVs (aVDPVs) for which there is insufficient evidence for definitive assignment to the other two categories. In 2005-2007, cVDPVs were found in Nigeria (type 2; 69 cases), Niger (two cases; importation from Nigeria), Cambodia (type 3; two cases), and Myanmar (type 1; four cases). In 2005-2007, iVDPVs were found in China, Iran, Syria, Egypt, and Kuwait, and aVDPVs were found in China and Israel.


To access a web-text (HTML) version of the complete article, go to: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5638a3.htm

To access a ready-to-print (PDF) version of this issue of MMWR, go to: http://www.cdc.gov/mmwr/PDF/wk/mm5638.pdf

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Immunization Action Coalition  •  Saint Paul, MN
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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.