Issue Number 36
December 17, 1998
CONTENTS OF THIS ISSUE
- CDC responds to questions about
influenza vaccine and
Guillain-Barre Syndrome
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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 |
