Gabor Szendi:
Hepatitis B vaccine carries a significant risk of Multiple Sclerosis

Source: Dominique Le Houézec: Evolution of Multiple Sclerosis in France since the beginning of hepatitis B vaccination. Immunologic Research, November 14, 2014.

Since the introduction of mass vaccination against Hepatitis B in France, post-vaccine Multiple Sclerosis has led to international epidemiological studies. This confirmed the sharp rise in annual diagnoses of newly diagnosed Multiple Sclerosis reported by French health insurers in the 1990s. Almost twenty years later, a retrospective reaction can be deduced from official data and national adverse reaction data.

 

 

The statistical data obtained shows a significant association between the number of Hepatitis B vaccines and the number of cases of Multiple Sclerosis occurring within one to two years, following adverse reaction to system vaccination. Applying the Hill criteria to these data indicates that there may be a causal relationship between Hepatitis B vaccination and Multiple Sclerosis.

About half a century ago, H. Miller first raised the idea that vaccines can cause Multiple Sclerosis (MS) (1). Vaccination for Hepatitis B is of particular concern as it was massively introduced in France in a relatively short period of time. In 1992, the World Health Organization recommended universal Hepatitis vaccination for infants to banish the Hepatitis virus from the world. The WHO also recommended vaccination of teenagers in countries with low infection rates.

In 1994, French public health authorities had every first-grade high school child vaccinated. The following year, vaccination became part of the vaccine protocol for infants and pre-teens. Adults were encouraged to get vaccinated, and 20 million were vaccinated between 1994 and 1997. Some vaccinated adults developed MS, which led to the initiation of an adverse reaction monitoring system. The investigation began in 1994 and was still ongoing when the media began reporting the relationship between vaccination and MS in 1998. As a result of this coverage, French authorities immediately stopped school vaccination for pre-teenagers and vaccination became less common in adults.

Numerous epidemiological studies have been conducted over a period of 10 years. Most studies found no association (2-6) or mild increased risk, which was not significant (7-8). However, other opinions were also expressed. For example, a study led by D. Costagliola showed an underreporting of side effects in data from an already published study (9). This unpublished study showed that the incidence of MS was 2 to 2.5 times higher than the officially reported cases (10). According to the post-calculation, Fourrier et al. (9) showed a significant relationship. Another case-controlled epidemiological study was conducted in the US with data from the adverse reaction monitoring system there. According to this, vaccinated adults were 5.2 times more likely to develop MS after Hepatitis B vaccination (11). In an English study that followed adults for 3 years after vaccination, there was 3.1 times risk of MS from vaccination (12). A French study looking at the effects of the Engerix B vaccine in children showed a 2.77 times increase in risk over a 3-year follow-up, albeit as a trend (i.e., the result is not significant).

With this baseline, I sought a relationship between the temporal distribution of Hepatitis B and the incidence of MS based on the Adverse Effect Monitoring (ANSM) system and National Health Insurance Data (CNAM) in France. The analysis showed a significant association between the number of vaccinations and the increased number of MS cases.

The analysis talked about demyelination if there was only one condition, and MS when there were at least two relapses. Since the French side-effects monitoring relies on "spontaneous reporting", it can be estimated that this means 1-10% of real cases (16). The data were supplemented with data from the REVAHB organization. REVAHB collects data on Hepatitis B vaccine victims. The side-effect monitor does not count cases where a letter requesting confirmation from the doctor has been left unanswered. This can be a source of underreporting.

In 1993, the number of new MS patients was stable at 2,500 per year. In the following years, particularly from 1996, the number of cases started to increase, and in 2003, 4,500 new patients were registered. In 1993, there were 5.3 new MS patients per 100,000 people, while 10 years later, this figure increased to 8.7 per 100,000. This represents a 65% increase in the number of newly ill patients over a period of 10 years. In France, in the Burgundy region, between 1993 and 1997, there were 4.3 new MS patients per 100,000 people, while between 2001 and 2007, there were 7.6 and then 8.5 new MS per 100,000 people. In 1994, 40 out of 100,000 people suffered from MS (this is not the number of new patients, but the prevalence of existing patients). Twelve years later, there were 95 MS patients per 100,000 people.

 

 

The research clearly confirmed the link between HB vaccination and MS. This effect is primarily attributable to aluminum adjuvant.

Studies denying the relationship between MS vaccination and HB have been awarded study grants by the pharmaceutical industry (2-5). Other studies looked at too short a time interval (4, 7-8). The strength of this study is that it has processed data for 20 million people and has taken into account that aluminum adjuvant has been present in the body for many years and that MS may develop later.

This risk should - or must - always be taken into account when we are vaccinating ourselves or making a vaccine compulsory. It is important to research which component of the vaccine causes risk, because it would be better for everyone if they are able to choose between two bad options: risking Hepatitis B without vaccination, and Multiple Sclerosis with vaccination.

 

References

1. Miller H, Cendrowski W, Schapira K. Multiple sclerosis and vaccination. Br Med J. 1967;2:210-3.
2. Zipp F, Weil JG, Einhaulp KM. No increase in demyelinating diseases after hepatitis B vaccination. Nat Med. 1999. doi:10. 1038/12376.
3. Sadovnick AD, Scheifele DW. School-based hepatitis B vaccination programme and adolescent multiple sclerosis. Lancet. 2000. doi:10.1016/S0140-6736(99)02991-8.
4. Ascherio A, Zhang SM, Hernan MA, et al. Hepatitis B vaccination and the risk of multiple sclerosis. N Engl J Med. 2001. doi:10.1056/nejm200102013440502.
5. DeStephano F, Verstraeten T, Jackson LA, et al. Vaccinations and risk of central nervous system demyelinating diseases in adults. Arch Neurol. 2003. doi:10.1001/archneur.60.4.504.
6. Ramagopalan SV, Valdar W, Dyment DA, et al. Canadian Collaborative Study Group. Association of infectious mononucleosis with multiple sclerosis. A population-based study. Neuroepidemiology. 2008. doi:10.1159/000201564.
7. Touze E, Fourrier A, Rue-Fenouche C, Ronde-Oustau V, Begaud B, Alperovitch A. Hepatitis B vaccination and first central nervous system demyelinating event: a case-control study. Neuroepidemiology. 2002. doi:10.1159/000059520.
8. Sturkenboom MCJM, Abenhaim L, Wolfson C, Roullet E, Heinzlef O, Gout O. Vaccinations, demyelination and multiple sclerosis study (VDAMS): a population-based study in the UK. Pharmacoepidemiol Drug Saf. 1999;8(Suppl):S170-1.
9. Fourrier A, Begaud B, Alperovitch A, Verdier-Taillefer MH, Touze E, Imbs JL. Hepatitis B vaccine and first episodes of central nervous system demyelinating disorders: a comparison between reported and expected number of cases. Br J Clin Pharmacol. 2001. doi:10.1046/j.1365-2125.2001.01364.x.
10. ANSM. Vaccination anti hépatite B: MISE A JOUR DES DONNEES ET DES ETUDES DE PHARMACOVIGILANCE. Février 2000 (in French). http:// ansm.sante.fr/var/ansm_site/storage/original/application/b460abed 4a9a61d8dad78d4364033354.pdf. Accessed 31 Oct 2014.
11. Geier DA, Geier MR. A case-control study of serious autoimmune adverse events following hepatitis B immunization. Autoimmunity. 2005. doi:10.1080/0891693050014448438.
12. Hernan MA, Jick SS, Olek MJ, Jick H. Recombinant hepatitis B vaccine and the risk of multiple sclerosis. Neurology. 2004. doi:10.1212/01.WNL.0000138433.61870.82.