Hepatitis B vaccination and central demyelination - History, description and observed/expected analyses of 624 cases reported to the French pharmacovigilance over a 20-year period

摘要

Background: Confidence in vaccines is essential for achieving targeted immunization coverage. The current skepticism about vaccine safety feeds on controversies such as the suspicion about a link between hepatitis B (HB) vaccination and central demyelination (CD) after the massive HB immunization campaign in France in 1994-2000. This study assesses the robustness of this signal by analysing all validated cases reported in 1980-2000 and by conducting observed-to-expected (OE) comparisons.