Multiple vaccine Hexavac, given out in the early 2000’s , was associated with a high risk of sudden infant death and sudden childhood death, to a level of one death per 400,000 individuals the 2nd year of life. This didn’t include babies under one who died.
Children were sometimes over the age that SIDS typically occurs (for example, one child died at 17 months and one died at 23 months). There were reports warning of the statistical link between the multiple vaccine and the deaths, but to begin with these were ignored. As more children died, the risk ratio became such that they decided to withdraw the vaccine.
However, official reports after the withdrawal listed poor efficacy as the reason for withdrawal and made no mention of SIDS or SUDS. Vaccines are very rarely withdrawn for efficacy reasons, MMR has an efficacy rate of round 69%, mumps vaccine was proven not to work in a court of law, the cochrane review says flu vaccines don’t work and TB vaccine was shown not to work in 1979 but all these vaccines are still used.
There were also NO reports listing efficacy as a problem prior to withdrawal.
When concerned individuals and doctors have attempted to bring up this disparity, they have been ignored or censored. Clearly, the authorities were desperate for the vaccines/SIDS connection to be covered up and they lied about efficacy to do this.
The official report (which in the end concluded that doctors should continue giving the vaccine anyway) said:
‘The CHMP had previously concluded that there is a statistical signal of an excess occurrence of cases of SUD within 24 hours of a booster vaccination with Hexavac during the 2nd year of life.The signal had been identified in the observed/expected analysis (see above). The investigators regarded their data as evidence for “a strong risk signal for Hexavac booster vaccinations in the 2nd year of life and SUD.
They find that chance is a very unlikely explanation of the finding, given the fact that the lower confidence limits for both day 1 and day 2 were greater than unity, i.e. 3.8 and 4.8 respectively. The absolute risk (reporting rate) of death would correspond to 1 death due to SUD in 300,000-400,000 children in the 2nd year of life.’
FATALITIES WITH HEXAVALENT VACCINES (HEXAVAC, INFANRIX HEXA)
Since the introduction of the two hexavalent vaccines HEXAVAC and INFANRIX HEXA in the autumn of 2000, five children in the EU have died within 24 hours of being vaccinated. Four reports of unexplained deaths have been received from Germany and one from Austria (1). To date, around 1.6 million children have been inoculated with hexavalent vaccines in Germany. This results in an incidence of one report of unexplained death per 400,000 children. Two of the children who died were 4 or 5 months old, two were 17 months and one was 23 months old. All had been considered healthy. Suspicions that risk factors such as a family history of convulsions should be regarded as a trigger for the fatalities or that Sudden Infant Death Syndrome (SIDS) might be involved have not been substantiated (1,2). SIDS usually occurs at around 3 months of age. In 90% of cases, SIDS occurs before the age of 6 months (3).
In the case of the four German infants, cerebral oedema was found at autopsy (1). Information on clinical symptoms that preceded death is lacking from the statements published by the authorities.
The two hexavalent vaccines became notorious for side effects even when they were being licensed. Sharp increases in temperature are considered a particular problem, these temperatures exceeding 40 degrees Celsius (a-t 2001; 32: 73-4). Booster vaccinations are followed particularly frequently by temperature increases to 38 degrees Celsius and above, according to studies, for example, in 29% to 30% of cases instead of 8% to 20% after basic immunisation (3).
Despite the fatalities, the EMEA sees no grounds for a reappraisal of either vaccine (2). In our view, however, the suspicion of a link with vaccination is not ruled out. The all-clear from the authorities and their reasoning (“the great benefit far outweighs the risks” (1)) are incomprehensible to us as the same protective effect can also be achieved with vaccines of less complex composition. Until clarification is achieved, we recommend resorting to proven vaccines with fewer components.
Paul-EHRLICH-Institut: “Informationen für Ärzte und Apotheker” dated 28 April 2003;
EMEA: Public Statement of 28 April 2003
EMEA: European Public Assessment Report (EPAR) HEXAVAC, Rev. 3, 30 April 2003
However, the World Health Organization (WHO) made no mention of this after withdrawal and simply wrote:
‘The European Medicines Agency has recommended the suspension of the marketing authorization for Hexavac. This is a precautionary measure taken amidst concerns about the vaccine’s long-term protection against hepatitis B following the identification of a decreased immunogenicity of the hepatitis B component in the vaccine. Hexavac is a vaccine for infants and children against diphtheria, tetanus, whooping cough (pertussis), hepatitis B virus, polio virus and Hemophilus influenzae type b.’
Dr Marc Girard, a molecular biologist, former Director of the European Research Center for Virology and Immunology, wrote to the BMJ about the issue and the letter was denied publication in a further effort to censor the vaccines/SIDS/SUDS connection.
The following correspondence was rejected in 2005 by the British Medical Journal. Having regard to the persistent stubborness of regulatory bodies not to see evidence of toxicity before new drugs are registered, it is still of relevance…
The withdrawal of the vaccine Hexavac® by the European Medicine Agency (EMEA), in September 2005, caused surprisingly few reactions. EMEA’s reason for withdrawal (lack of efficacy) is questionable: early post-marketing period is usually not devoted to efficacy re-assessments, whereas the last public statement on Hexavac (Dec 2003) was related with a safety problem (sudden infant death syndrome [SIDS]). An additional comment from the French Agency (the alleged problem of efficacy could come from variations in the manufacturing process) is frankly disturbing, concerning one major firm normally viewed as a crucial safeguard in case of bioterrorism or avian flu, and which already has the worrying record of selling in France a hepatitis B vaccine (Genhevac®) the dossier of which was apparently never assessed a sufficient to justify registration in any other developed country.
Within the same time, Zinka et al (1) published an impressive series of six SIDS after Hexavac injection and reported various extrapolations suggesting a minimum 500% increase of cases in a country like Germany: these figures are credible, since the scientific discussion on Hevaxax published on the EMEA site when the product was registered mentioned 7 cases of SIDS among 3 905 infants included in the development studies and followed for safety during a 1-month period, which corresponds to a 35-fold increase as compared to the expected number over a similar period…
A rapid calculation suggests that the presumed small decrease in efficacy claimed by EMEA would have, at worst, accounted for less than one case/year of complicated hepatitis in countries like Germany or France; in contrast, available evidence already shows that the potential of SIDS could have accounted for dozens or even hundreds of deaths each year within the same countries. It is therefore difficult to grasp the hierarchy of health priorities adopted by European agencies: having regard to the precedent of tolcapone (Tasmar®), this is not the first time…
Competing interests : Dr Girard works as an independent consultant for pharmaceutical industry, including vaccine manufacturers and a number of their competitors.
1. Zinka B, Rauch E, Buettner A, Rueff F, Penning R. Unexplained cases of sudden infant death shortly after hexavalent vaccination. Vaccine 2005 May 18.