[Central nervous system demyelinating disease following hepatitis B vaccination with GenHevac B. Review of ten years of spontaneous notifications (1989-1998)].
OBJECTIVE
To describe and analyze spontaneous reports of central nervous system (CNS) demyelinating disease including multiple sclerosis, following vaccination with GenHevac B vaccine, from 1989 to December 31, 1998.


METHODS
Descriptive analysis of adverse event reports in the vaccinated population, including the number of cases of CNS demyelinating disease, their frequencies, their dates of onset in relation to dates of report and their distribution according to age, sex and the number of injections. A Kaplan-Meier curve was used to analyze the time period between the last dose of vaccine and the onset of CNS demyelinating disease.


RESULTS
Overall, 187 cases of CNS demyelinating disease were spontaneously reported, (0.54 reports per 100,000 doses of GenHevac B distributed). The average time period between the occurring date of onset of the disease and its subsequent report was 24 months. The average age of onset was 31.7 years old and 73% of cases were women. The time between the last dose of vaccine and the onset of disease was regularly distributed from 1 day to 5 years (median: 60 days).


CONCLUSIONS
These results, together with available clinical, epidemiological data regarding multiple sclerosis, do not suggest a causal relationship between CNS demyelinating disease and vaccination with GenHevac B.
Soubeyrand
B
B
bsoubeyrand@fr.aventis-pasteur.msd.com
Boisnard
F
F
Bruel
M
M
Debois
H
H
Delattre
D
D
Gauthier
A
A
Soum
S
S
Thébault
C
C
D000328:Adult; D017668:Age of Onset; D002493:Central Nervous System Diseases / Q000453:epidemiology / Q000209:etiology*; D003711:Demyelinating Diseases / Q000453:epidemiology / Q000209:etiology*; D005260:Female; D005602:France / Q000453:epidemiology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D008297:Male; D009103:Multiple Sclerosis / Q000453:epidemiology / Q000209:etiology
C075656:GenHevac B Pasteur; D017325:Hepatitis B Vaccines