Hepatitis B vaccine – An urgent need of re-appraisal

Hepatitis B vaccine

Further a publication on the risk of multiple sclerosis after hepatitis B vaccine1, this paper briefly summarizes evidence pointing to an unusual toxicity of this vaccine.

It was rejected by the Editor-in-chief on the following basis: “It is too difficult to understand. I do not think that it adds sufficiently to the thoughtful and balanced editorial and the original paper”.

Performed by an American team on a British database, Hernan et al’s
investigation (14 Sept, 838-842) is a definite blow for all those who
upheld the lame argument that doubts on the safety of hepatitis B vaccine (HBV) would refer to a new French paradox. It is not true that “numerous studies have not corroborated the association [with multiple sclerosis]” (p. 772-773).

The inconsistencies of some2 were so gross that in its public report of
Feb 2000, the French Agency recommended to “discard” this contribution.

The biases of DeStefano et al (2003) 3 were blatant (e.g. imbalance between cases and controls for their neurological history).

Of the 3 case-control studies undertaken by the French Agency, all of them showed an increase in the risk of post-vaccinal multiple sclerosis (MS), lack of statistical significance being simply an expected consequence of a repeated lack of statistical power: in a Correspondence discussing the biases of Ascherio et al’s investigation 4, the French investigators asserted that the American results were consistent with “the same increased risk” as in France and concluded that “at best”, it was now impossible to rule out an “epidemiologically important increase in risk”…

Another strong argument for iatrogenic causality is given by an impressive increase in paediatric MS, a very rare entity prior to mass vaccination in children. In France, where “hard” epidemiological data are scarce, those of the national system of health insurance showed an impressive increase in MS as well as in “severe neuromuscular disorders” after mass vaccination. Dozens of reports have been published suggesting a worrying link between HBV and
a number of non-neurological auto-immune diseases5.

In addition to these articles, two case/control studies performed by
the French agency (Feb 2000 report) demonstrated a statistically
significant increase in the risk of Graves’ disease as well as that of

The only point on which one cannot agree with Hernan et al is about the benefits of HBV, for at least 3 reasons: 1) data on hepatitis B hazards are more consistent with manufacturers interests than with epidemiological evidence 6; 2) there remains an unusual uncertainty about the duration of immunity given by this vaccine; 3) as there is ample evidence that the hazards of this vaccine, not only neurological, have been systematically
neglected, there is an urgent need for a re-appraisal the benefit/risk
ratio of this vaccination.

Competing interest: Dr Girard works as an independent consultant for pharmaceutical industry, including vaccine manufacturers and a number of their competitors.

  1. Hernan MA, Jick SS, Olek MJ, and Jick H. Recombinant hepatitis B vaccine and the risk of multiple sclerosis: A prospective study. Neurology 2004; 63: 838-842.
  2. Zipp F, Weil JG, Einhaupl KM. No increase in demyelinating diseases after hepatitis B vaccination [letter]. Nature Medicine 1999;5:964-5.
  3. DeStefano F, Verstraeten T, Jackson LA et al. Vaccinations and risk of central nervous system demyelinating diseases in adults. Arch Neurol 2003;60:504-9.
  4. Ascherio A, Zhang SM, Hernan MA et al. Hepatitis B vaccination and the risk of multiple sclerosis. N Engl J Med 2001; 344:327-32.
  5. Girard M. Autoimmune hazards of hepatitis B vaccine. Autoimmunity Reviews 2005; 4/2: 96-100.
  6. Puliyel J. Plea to restore public funding for vaccine development. Lancet 2004; 363 : 659.