Public !!  `!h Service

  xmmdu

Date  4 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 performaned 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.

Y Arthur Hull Hayes, Jr., M.D.