In what was called a “thunderclap in the vaccine industry,” French authorities have opened a formal investigation concerning a hepatitis B vaccination campaign by GlaxoSmithKline and Sanofi Pasteur in the 1990s. It is alleged that the companies failed to fully disclose neurologic side effects. Another investigation opened by Judge Marie-Odile Bertella-Geffroy concerns the death (“manslaughter”) of a 28-year-old woman from multiple sclerosis, allegedly connected to the vaccine (Le Figaro 1/31/08).
From 1994 to 1998, almost two-thirds of the French population and almost all newborn babies were vaccinated against hepatitis B, but the campaign was temporarily suspended because of concerns about side effects.
Some 30 plaintiffs, including the families of five patients who died after the vaccination, have launched civil actions (Reuters 1/1/08).
A British case-controlled analysis showed an odds ratio of 3.1 (95% CI 1.5-6.3) for first symptoms of multiple sclerosis in recipients of recombinant hepatitis B vaccine compared to controls. Two previous French studies had shown a RR of about 1.5. Other studies showed a nonsignificant increase or null findings, especially when date of diagnosis rather than date of first symptoms was used (Neurology 2004;63:838-842).
According to attorney Clifford Miller, “British doctors administering hepatitis B vaccine to infants could face criminal prosecution if fully informed consent is not obtained. Civil prosecution for damages is possible over 21 years later if the injured survive as adults” (UK Press Association Newswire/Romeike, September 2005).
The hepatitis B vaccine has been considered “one of the safest vaccines ever produced” (Neurology, op. cit.). On the other hand, French medical expert Marc Girard has said that “for a preventive measure, hepatitis B is remarkable for the frequency, variety and severity of complications from its use” (Romeike, op.cit.)
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