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Issue Number 36            December 17, 1998

CONTENTS OF THIS ISSUE

  1. CDC responds to questions about influenza vaccine and
    Guillain-Barre Syndrome

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(1)
December 17, 1998
CDC RESPONDS TO QUESTIONS ABOUT INFLUENZA VACCINE AND GUILLAIN-BARRE SYNDROME

CDC today released information on their website for health professionals who have questions or need to respond to inquiries about influenza vaccine generated by an article entitled, "Guillain-Barre Syndrome (GBS) and the 1992-93 and 1993-94 influenza vaccines." The article appeared in today's issue of the "New England Journal of Medicine."

Walter Orenstein, MD, Assistant Surgeon General and Director of CDC's National Immunization Program, alerts the reader to the article in a "Dear Colleague" letter and restates the national recommendation to vaccinate anyone who wishes to prevent influenza, especially the elderly and those at high risk for developing complications associated with influenza. The full text of Dr. Orenstein's letter follows:

December 11, 1998

Dear Colleague:

We wish to alert you to an article scheduled for the December 17, 1998, issue of the "New England Journal of Medicine" entitled "Guillain-Barre Syndrome (GBS) and the 1992-93 and 1993-94 influenza vaccines." The publication releases the results of a collaborative study in four states between the University of Maryland (UMD) and the Centers for Disease Control and Prevention (CDC), National Immunization Program (NIP).

This study was undertaken among persons 18 years of age or older because the number of GBS cases reported to the Vaccine Adverse Event Reporting System (VAERS) increased from 37 to 74 between 1992-93 and 1993-94. The CDC and the Food and Drug Administration (FDA) carefully monitor the safety of licensed vaccines using tools such as the VAERS, a passive surveillance reporting system. The purpose of the study was to determine if the observed increase in VAERS reports of GBS was due to the change in the influenza vaccine or due to other reason(s).

The study data, while not definitive, show an extremely small (one per million) increased risk of GBS during the six weeks following influenza vaccination during the 1992-93 and 1993-94 seasons. This is in addition to the background rate of one to two GBS cases per one million people over any six-week period in any year. The estimated risk for persons younger than 45 years was zero--approximately 3.8 million doses of vaccine were administered to persons 18-44 years of age, yet no vaccine-related GBS cases were observed in these people. The risk in
older persons was higher, however.

Even if GBS is a true side effect of influenza vaccine, the attributable risk of one additional GBS case per million vaccinations is much less than the risk of severe influenza cases that can be prevented with the vaccine. Influenza is a preventable disease, yet each year in the United States it kills an average of 20,000 persons and hospitalizes 130,000 persons with influenza-related complications. More than 90% of those who die are persons 65 years of age or older.

After considering these data and the known risks of influenza, the CDC continues to recommend the current influenza vaccine to anyone who wishes to prevent influenza, especially the elderly and those at high risk for developing complications associated with influenza. Persons concerned about the potential risk of GBS following influenza vaccination should consult their health- care provider.

We have prepared information for health-care professionals who may have questions or need to respond to inquiries about influenza vaccination. The information includes key communication points; questions and answers on influenza, GBS, influenza vaccine, and the study; the study abstract; the Advisory Committee on Immunization Practices (ACIP) 1998-99 influenza recommendations; and the Vaccine Information Statement on 1998-99 Influenza Vaccine.

On December 17, we will make these materials available through the NIP Internet site at <http://www.cdc.gov/nip/vacsafe> (click on hot topics). For additional information on immunization, we invite you and your partners to call the National Immunization Information Hotline at 1-800-232-2522 (English), 1-800-232-0233 (Spanish), or visit the NIP Internet site at <http://www.cdc.gov/nip>

Sincerely,

Walter A. Orenstein, M.D., M.P.H.
Assistant Surgeon General
Director, National Immunization Program, CDC

Editors' note:
The package of influenza information on CDC's website includes the above "Dear Colleague" letter as well as several additional key documents. To go directly to the package of information prepared by CDC, click here:   http://www.cdc.gov/nip/vacsafe/vaccinesafety/hottopics/flu.htm

You may also click below for any of the individual pieces which are part of CDC's website information on influenza.

1. "Dear Colleague" letter (from Dr. Walter Orenstein, NIP Director).
http://www.cdc.gov/nip/vacsafe/vaccinesafety/hottopics/gbsltr.htm

2. "The Guillain-Barre Syndrome (GBS) and the 1992-93 and 1993-94 Influenza Vaccines"
http://www.cdc.gov/nip/vacsafe/vaccinesafety/publications/gbsflu.htm

3. Question and Answer Document Including Information on Influenza, GBS, Influenza Vaccine, the Study and Key Communication Points
http://www.cdc.gov/nip/vacsafe/vaccinesafety/hottopics/gbs.htm

4. The Advisory Committee on Immunization Practices (ACIP) Statement on the Prevention and Control of Influenza
http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/00052500.htm

5. The Vaccine Information Statement (VIS) on the 1998-99 Influenza Vaccine
http://www.cdc.gov/nip/publications/VIS/vis-flu.pdf

6. Information on Influenza Disease (from the National Center for Infectious Diseases)
http://www.cdc.gov/ncidod/diseases/flu/fluvirus.htm

 

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This page was updated on December 17, 1998