The challenge by Dr Jacob Puliyel previously reported in AoA to explain an excess in 69 deaths from sudden infant death syndrome (SIDS) following the administration of GSK Infanrix Hexa hexavalent vaccine has met with an irrelevant response from the authors of a paper exonerating the vaccine. Elisabetta Franco, replying on behalf of the eight author of the Baldo study writes:
The opinion of all the Authors is that the suggested imbalance in reported SIDS between 0-9 days and 10-19 days periods represents a well recognised bias in spontaneous report reporting, where the shorter the time that has elapsed between the vaccination procedure and the event, the more likely it is to be perceived as a trigger and subsequently be reported.
As Puliyel (consultant paediatrician at St Stephen’s Hospital, Delhi) points out this would have been alright if we were talking about adverse reaction reports but these are SIDS reports. Two of the study authors are direct employees of GSK and other have a multitude of conflicts acknowledged in their paper. The anomaly of the SIDS deaths came to light after an Italian court ordered the publication of the data following the regression of child into autism.
The original confidential report by GSK hid the possible impact of the vaccine by spreading the deaths over a three week period. Puliyel had written:
However if one analyses the data looking at deaths in first 10 days after administration of vaccine and compares it to the deaths in the next 10 days, it is clear that 97% of deaths (65 deaths) in the infants below 1 year, occur in the first 10 days and 3% (2 deaths) occur in the next 10 days. Had the deaths been coincidental SIDS deaths unrelated to vaccination, the numbers of deaths in the two 10 day periods should have been the same…The decelerating incremental-deaths further supports the contention that there is a clear relationship of ‘sudden death’ to the vaccination episode. 42 deaths had taken place in the first three days after vaccination, 16 deaths in the next 3 days between day 3 and day 5, 3 deaths between day 6 and day 8, 2 deaths between day 9 and day 11, and there were only 2 deaths in all of the remaining 10 days. The fact that rate of deaths decreases rapidly and continuously as time elapses after immunization, makes it clear that the deaths are related to the vaccination episode.
The 16 excess deaths on day 0 is perhaps an even more marked effect because infants are unlikely to be vaccinated at midnight and many of the background deaths will have occurred before administration. After several days Dr Franco has not been back to defend her explanation or comment further.
In a further answer to Dr Tamás Ferenci of Budapest details another study documenting the problem.
Finally, Dr Ferenci says that active vaccine safety studies are better than passively acquired data. For well designed, managed and executed studies I wholeheartedly agree with him.
The TOKEN study aimed to assess comprehensively a possible causal relationship between vaccination and unexplained sudden unexpected death of children between their 2nd and 24th month of life. The study was supported and sponsored by the Paul-Ehrlich-Institute (PEI) and the Federal Ministry of Health (Bundesministerium für Gesundheit). Unfortunately this large study with a wealth of data has not been published in an indexed peer reviewed journal as yet. It is available here:
Parents of children who had died of SIDS were requested to participate in the study. 37.6% (254 cases) could be included in the study, where parental consent was obtained. Tables 31 and 36 show significantly increased risk of unexplained sudden unexpected death in the first 3 days after hexa- or pentavalent vaccination (1st and 2nd year of life).
So it appears that active studies have confirmed that there are two vaccines which cause 'sudden deaths'. I am grateful that the Italian Court has allowed public scrutiny of GSK's PSUR reports held as confidential by the EMA.
It is evident that European Medicines Agency have been content to sit on this matter with GSK watching more infants die from the vaccine, and even now they fail to respond even though the matter has been brought glaringly into the open.
John Stone is UK Editor for Age of Autism.