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The C. Everett Koop Papers

Memorandum from Arthur Hull Hayes Jr., Food and Drug Administration to C. Everett Koop pdf (78,028 Bytes) transcript of pdf
Memorandum from Arthur Hull Hayes Jr., Food and Drug Administration to C. Everett Koop
Number of Image Pages:
1 (78,028 Bytes)
1983-01-06 (January 6, 1983)
Hayes, Arthur Hull Jr
Food and Drug Administration
Koop, C. Everett
Prepared: North, Mark
This item is in the public domain. It may be used without permission.
Medical Subject Headings (MeSH):
Hepatitis B Vaccines
Guillain-Barre Syndrome
Drug Approval
Drug Industry
Exhibit Category:
Reproduction and Family Health
Metadata Record Memorandum from C. Everett Koop to William H. Foege, Centers for Disease Control and Arthur Hull Hayes Jr., Food and Drug Administration (December 9, 1982) pdf (41,791 Bytes) transcript of pdf
Box Number: 23
Folder Number: 20
Unique Identifier:
Document Type:
Physical Condition:
Series: Sequential Files
SubSeries: February 1983
Folder: Guillain-Barre syndrome with heptavax B vaccine, 1983 Feb
Date: JAN 6 1983
From: Commissioner of Food and Drugs
Subject: Hepatitis B Vaccine and Guillain-Barre Syndrome
To: The Surgeon General
This is in response to your note of December 9, 1982 concerning a letter you received from Mrs. Diane Schweber, whose husband, Dr. Saul Schweber developed Guillain-Barre syndrome after having been given Hepatitis B vaccine.
We have been following this matter closely and had been informed of Dr. Schweber's illness earlier by the manufacturer, Merck Sharp & Dohme, and the Centers for Disease Control. Our Office of Biologics, which is responsible for the control of biological products including this vaccine, has been in close contact both with CDC and Merck regarding the evaluation of all adverse reactions temporally associated with administration of this product.
Before licensure of the vaccine, 19,000 individuals had been vaccinated and in the period since marketing began in July, 1982, it is estimated that well in excess of 200,000 doses have been administered. No illnesses suggestive of Guillain-Barre syndrome were seen in the studies conducted before licensure. In the surveillance performed since licensure, a total of 64 reactions of all types have been reported temporally associated with administration of the vaccine. Included among these is a single occurrence of Guillain-Barre syndrome (Dr. Schweber's illness); this is the only illness among the 64 reports that constitutes a significant health problem. The incidence of Guillain-Barre syndrome in unvaccinated persons has been estimated to be in the order of 0.7 cases per million persons per month. Thus, the occurrence of Guillain-Barre syndrome in recipients of hepatitis B vaccine does not appear to be significantly different from that which might have been expected to occur by chance alone.
We are continuing to monitor the adverse reaction reports closely for any evidence of significantly increased risk of Guillain-Barre syndrome or other serious adverse effects.
Arthur Hull Hayes, Jr., M.D.
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