Adverse Events Caused by Infanrix hexa Vaccine Results in 69 Deaths
Dr Puliyel analyzed the data and found that 97% of deaths (65 deaths) following Infanrix hexa , occur in the first 10 days and only 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 manufacturers of this vaccine GlaxoSmithKline (GSK) disclosed in a confidential report to the Regulatory Authority that about 72 babies died within 20 days of receiving Infanrix hexa. They reported that the deaths of these children were due to Sudden Infant Death Syndrome (SIDS) and Sudden Unexpected Death Syndrome (SUDS) unrelated vaccination. However an Italian Court of Justice Nicola Di Leo ordered that it be made public and is now available on the internet (http://autismoevaccini.files.wordpress.com/2012/12/vaccin-dc3a9cc3a8s.pdf)
Analysis of the data shows that at least 69 out of 72 deaths reported were likely to have been caused by the vaccine.
Infanrix hexa combines vaccines against 6 diseases [namely Diptheria, Tetanus and Acelluar Pertusis (whooping cough), Hepatitis B, inactivated Poliomyelitis and Haemophilus influenza type B] in a single vaccine. The DPT vaccine, Hepatitis B, Hib and injectable Polio have been administered separately in the past. The newer combined vaccine is being promoted on the grounds that it reduces the number of injections given to babies. The safety of the combination is now being questioned.
The manufacturers had reported these sudden and unexpected deaths were not caused by the vaccine but were merely coincidental SIDS deaths. Dr Puliyel analyzed the data and found that 97% of deaths (65 deaths) in the infants below 1 year, occur in the first 10 days and only 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.
Dr Puliyel has published his findings on the US National Library of Medicine National Institutes of Health PubMed Commons. This was being done he writes, “to put it up for open review by the scientific community, on account of its urgency, as this is a matter that involves the lives of children and there is a continuing risk to children”.
In some ways this is similar to Pentavalent vaccine combining vaccines against 5 disease ( DPT, Hepatitis B, Hib vaccines) which has caused a large number of deaths in developing countries in Asia. Puliyel notes that these deaths are completely unnecessary as the vaccines could have been given separately, and separately they have a long track record of safety. One hopes that the findings will result in an honest acknowledgement of the harms being done by these combined vaccines.
Recently the CIOMS and WHO altered the way safety of vaccines is evaluated and Puliyel notes that the revised method facilitates misclassification of adverse events following immunization as has happened in this case.
Puliyel also questioned why safety data has to be kept confidential. The GSK report released recently by the Italian Court is dated 16 December 2011. Had it been made public at that time, a large number of unnecessary deaths in 2012, 2013 and 2014 could have been avoided.
There is a momentum for disclosure of drug trial data. It is hoped this will extend to safety data collected under Regulatory Rules
The PubMed Commons article can be accessed here.
We invite you to read more about these deaths at ChildHealhySafety