It is the unanimous view of the involved international scientists and expert societies that based upon all available analyses (mechanism, epidemiology) there is no evidence for a causal relation between hepatitis B vaccination and a subsequent onset of multiple sclerosis (MS) (1, 2, 4, 5, 11, 12).
The scientific proof that there is no correlation between an individual case of vaccination (or other event) and a subsequent disease is impossible as a matter of principle.
With respect to the sentence of the European Court:
- The sentence is not issued regarding an individual case but with respect to the consideration of evidence of national courts in cases of product liability
- There are no new findings with respect to the scientific evidence regarding a correlation between a hepatitis B vaccination and a subsequent occurrence of a MS. This question is not even subject of the sentence. The court argues on the assumption that a causal relationship cannot be proven scientifically, but neither can the absence of such a relationship.
The equal appraisal of these two situations (provalbelness versus non-provableness of a correlation) poses the important problem of this sentence.
For exemplification: An individual suffers from a road traffic accident one year prior to the occurrence of a MS. According to all available knowledge and ‘common sense’ there is no causal relation between these two events. The formal scientific proof that there is no causal relationship in this individual case is nonetheless impossible.
- The court argues that in this situation of a scientific dispute the plaintiffs right can be upheld when there are certain indications that a causal relationship could be possible (in this particular case the chronological connection as well as the fact that there was no family history for the disease).
- The sentence apparently attempts to reduce the burden of proof for the plaintiffs. This notion is comprehensible from a humane point of view but remains highly problematic and plain wrong from a scientific point of view.
It is imperative to continuously emphasize, that this sentence contains no new evidence but simply alters the appraisal of indications without evidentiary value. Such an approach blatantly violates good scientific practice and in this particular case substantially harms the acceptance of an exceedingly beneficial vaccination, which has the potential to eradicate hepatitis b worldwide.
Prof T Mertens Secretary General ESV, president German Commission for Vaccines
1. Adverse Effects of Vaccines: Evidence and Causality. Committee to Review Adverse Effects of Vaccines; Stratton KR, Ford A, Rusch E, Wright Clayton E., editors. Washington (DC); National Academies Press (US); 2011. PubMed PMID: 24624471.
2. Bulletin zur Arzneimittelsicherheit. Bundesinstitut für Impfstoffe und biomedizinische Arzneimit-tel. http://www.pei.de/DE/arzneimittelsicherheit-vigilanz/pharmakovigilanz/bulletin-zur-arzneimittelsicherheit/bulletin-arzneimittelsicherheit-node.html#doc3252570bodyText4
3. Datenbank mit Verdachtsfällen von Impfkomplikationen und unerwünschten Arzneimittelwirkun-gen. Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel. http://52625146fm.pei.de/fmi/webd/#UAWDB
4. Meyer C, Rasch G, Keller-Stanislawski B, Schnitzler N. Anerkannte Impfschäden in der Bun-desrepublik Deutschland 1990-1999. Bundesgesundheitsbl – Gesundheitsforsch – Gesund-heitsschutz 2002; 45-364-370.
5. PEI: Multiple Sklerose und Impfungen - Hepatitis-B-Impfung, http://www.pei.de/DE/arzneimittelsicherheit-vigilanz/archiv-sicherheitsinformationen/2005-1998/ablage2000-2005/2004-10-27-ms-hbv-studien.html;jsessionid=BE45F3BEBA38D32458FF18D730C0636A.1_cid354?nn=3257708
6. STIKO: Empfehlungen der Ständigen Impfkommission (STIKO) am Robert Koch-Institut – 2016/2017. Epid Bull Nr. 34, 2016. www.stiko.de
7. Vaccine Adverse Event Reporting System (VAERS) 1990 – last month, CDC WONDER On-line Database. United States Department of Health and Human Services (DHHS), Public Health Service (PHS), Centers for Disease Control (CDC) / Food and Drug Administration (FDA). Ac-cessed at https://wonder.cdc.gov/vaers.html
8. WHO (May 2014). Information on vaccine safety. http://www.who.int/vaccine_safety/committee/en/
9. WHO (March 2013). Causality Assessment of An Adverse Event following Immunization (AEFI). User manual for the revised WHO classification
10. WHO (March 2013). Aide-Mémoire on Causality Assessment. Adverse Event following Immun-ization.
11. Langer-Gould A, Qian L, Tartof SY, Brara SM, Jacobsen SJ, Beaber BE, Sy LS, Chao C, Hechter R, Tseng HF. Vaccines and the risk of multiple sclerosis and other central nervous system demyelinating diseases. JAMA Neurol. 2014 Dec;71(12):1506-13. doi: 10.1001/jamaneurol.2014.2633. PubMed PMID: 25329096.
12. Mailand, M.T. & Frederiksen, J.L. J Neurol (2017)