These days, the Robert Koch Institute (RKI) in Berlin has published a research, TOKEN-Studie they were examined 254 cases of Usuda (unexplained sudden unexpected deaths = deaths from sudden, unexpected and unexplained) occurring in Germany from July 2005 to 2008. The main purpose of this study was to discover if there is a causal relationship between hexavalent vaccines and sudden deaths in children between 2 and 24 months of age.
have been scientifically analyzed data collected from questionnaires completed by parents and physicians, documentation of vaccination and the results of autopsies. Was statistically evaluated a possible temporal link between vaccination and the cases by the method of Usuda-Self-controlled case-series (SCCS). To further strengthen the results obtained, an analysis was made with a design "case-control". In an independent study which covered the aspect of forensic medicine has been tried a possible pathogenesis, a process that is pathogenic in common between cases of sudden death occurred after vaccination.
All the results of various investigations indicate that the risk for a sudden and unexpected death was not increased in the week after vaccination with the hexavalent.
analysis with the SCCS method has found a risk on ( RR) of 0.59 ( confidence interval 95% 0.26 to 1.33) and design "case-control an adjusted odds ratio (OR ) of 0.53, 95% (confidence interval 0.20 to 1.37 ), then nessun'aumento risk.
carried out forensic examinations showed no pathogenic process in common.
In a separate analysis, that was decided only after it was shown that almost all cases of sudden death occurred after vaccination recognized risk factors for sudden death syndrome: sleep in the prone position, maternal smoking or overheating (heating, clothing, blankets).
Unfortunately, only approx. 40% of the parents had consented to participate in research. Parents whose children died shortly after vaccination showed a greater willingness to participate than those whose children had been vaccinated at a distance in time or at all. This fact leads to a distortion of the results and makes interpretation more difficult. For methodological reasons it is assumed that the results obtained by this research may overestimate the risk.
The full study can be downloaded here and was also made available a file with further details regarding this research. In
summary in German explains why this study has been done, called "TOKEN"
The October 23, 2000 were approved two vaccines hexavalent Infanrix Hexa ® e Hexavac ® . Negli anni successivi sono stati segnalati alcuni casi di morte improvvisa dopo la vaccinazione esavalente che ha costituito un segnale d'allarme per una possibile correlazione tra i vaccini esavalenti ed il rischio di morte improvvisa inaspettata. Ad un primo esame scientifico non era risultato nessun aumentato del rischio per quanto riguarda il primo anno di vita. I casi dei bambini nel secondo anno di vita erano troppo pochi per poter fare un'analisi probabilistica.
Lo scopo dello studio "TOKEN" era appunto scoprire se il vaccino esavalente aumenta il rischio di morte improvvisa, esaminando un numero più alto di casi. Va sottolineato that this study refers only to the vaccine Infanrix Hexa ® because in 2005 Hexavac ® was withdrawn from the market because the suspected EMEA and a reduction dell'immunogenità component of anti-hepatitis B, the long-term protection may in turn be decreased.
The study was conducted and fnanziato by Federal Ministry of Health ( BMG ) and the Paul - Ehrlich - Institut (PEI ) in funding were involved the oreover , the two pharmaceutical companies Sanofi Pasteur MSD and GlaxoSmithKline Biologicals . E ' been fixed in the contract che gli sponsor delle case farmaceutiche non avevano alcuna influenza sulla progettazione e l'attuazione dello studio nè potevano avere accesso ai dati. L a pianificazione e l' esecuzione di questo studio è stata accompagnata dal consiglio scientifico di esperti interdisciplinari internazionali.
