The authors researched the mortality rate following administration of two hexavalent vaccines (Infanrix Hexa and Hexavac) in Germany. For children in the second year of life, the mortality rate within 24 hours of Hexavac was 31 times higher than expected.
The authors note that the number of cases of SIDS occurring a few days after vaccination is likely to be underestimated, as these cases are not reported to the Paul Erlich Institute (which documents cases of vaccination adverse events). For example, only one of the six SIDS cases that occurred within two weeks after hexavalent vaccination was reported. This case occurred within 24 hours after the vaccination.
Unlike the previous study, a study of 3 million infants in Italy found no connection between hexavalent vaccine and SIDS in the second year of life. Instead it found that the risk of SIDS during the first week after Hexavac was 2.8 times higher, the risk of SIDS after the first dose of any hexavalent vaccine was 2.2 times higher, and the risk of SIDS during the week after the first dose of any vaccine was 1.5 times higher than in the control group.
The control group consisted of the same infants that were vaccinated, just before they were vaccinated and 14 days after. That is, if an infant died on the 15th day after the vaccination, his death would increase the likelihood that the vaccine was not related to SIDS, since that infant already would be a part of the control group.
The authors analyzed 300 death cases in Germany using a new statistical method and found that the fourth dose of the penta- or hexavalent vaccine was associated with a 16-fold increase in the risk of SIDS, and any dose of the vaccine was associated with a 2-fold increase in the risk.Beta-tryptase and quantitative mast-cell increase in a sudden infant death following hexavalent immunization. 2008, D'Errico, Forensic Sci Int
A healthy three-month-old infant refused to eat a few hours after the vaccination, then exhibited severe shortness of breath and was urgently taken to hospital, where he was diagnosed with shock and acute respiratory failure. Two hours after arriving at the hospital, despite resuscitation attempts, the child died.
He had high levels of beta-tryptase in his blood, from which the authors conclude that the cause of death was hexavalent vaccine (Infanrix Hexa).
A healthy three-month-old girl was vaccinated with hexavalent vaccine. An hour later she lost consciousness, another hour later an ambulance took her to a hospital, while attempting to resuscitate her. Two hours after arriving at the hospital, she was pronounced dead.
The authors point out that a full autopsy should be done at each case of SIDS, otherwise the connection between vaccination and death might not be established.
In 2003, the EMA (European analogue of the FDA) analyzed the deaths of 5 children who died within 24 hours after being vaccinated with hexavalent vaccine and concluded that vaccination is beneficial for every child in particular and for society as a whole, and the cause of death of these children remains unexplained and it is impossible to establish a causal relationship with the vaccination. EMA suggests that there is no plausible biological link between SIDS and the hexavalent vaccine.
In six SIDS cases that occurred within 48 hours of being vaccinated with a hexavalent vaccine, autopsies were performed in Munich Institute. 5 of the infants were vaccinated with Hexavac and one with Infanrix Hexa. In addition to neuropathological and histological abnormalities, an unusual swelling of the brain was evident in all cases.
Brain weight gain due to edema or hyperemia (overflow of blood vessels) is mainly observed after DTP vaccination. Two of the three tested for tryptase showed very high levels.
The authors conclude that after the introduction of hexavalent vaccine, the number of SIDS deaths immediately after vaccination increased 13 times.
11.8% of 110 sudden infant deaths occurred within a week after hexavalent vaccination (Infanrix Hexa and Hexavac). The authors suggest that some components of hexavalent vaccines can easily penetrate the hemato-encephalic barrier, which is still permeable in the first months of life, and they induce molecular changes in DNA, RNA and brain proteins that regulate vital functions. This is followed by lethal respiratory control disorder in predisposed infants. They note that the neurotoxicity of aluminum, including its ability to penetrate the hemato-encephalytic barrier and to induce inflammatory and neurodegenerative changes, has been demonstrated empirically.Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency. 2018, Puliyel, Indian J Med Ethics
The Infanrix Hexa manufacturer (GSK) submits to the EMA periodical confidential reports, which analyze the number of deaths immediately after vaccination and show that the number is lower than statistical expectations.
The authors analyzed three of these reports (15th, 16th and 19th), which were made publicly available by the Italian court, and found that the death cases that appeared in the 16th report were removed from the 19th. If we do take into account the cases from the 16th report, it turns out that the number of deaths within 4 days of vaccination among children over one year is much higher than could be expected.
The authors note that since SIDS statistics are collected by the manufacturer passively, its incidence is probably underestimated. On the other hand, the expected number of deaths is overestimated, since it is assumed that all the supplied vaccine doses have been used.
The authors do not understand why EMA accepted this report and call the manufacturer to explain why it removed these deaths from the report.
The authors tested 8 different vaccines for mercury and found it in a concentration of 10 ppb in one of them only (Infanrix Hexa). Then they tested three other Infanrix Hexa vials and found mercury in a similar concentration again. The authors note that although this concentration is well below the established safety limit (2 μg/ml), the results of this study suggest inaccuracies in official documents and public communications claiming that the vaccine contains no mercury. They call for an urgent solution of this issue.