'Doctor Claims That Hexavalent Infanrix Vaccine Causes Sudden Death Of Babies,' Anti-Vaccination Advocates Question Why Report Was Confidential

One doctor says there is a strong link between the Infanrix hexa vaccine and cases of sudden death among babies. The manufacturer of the hexavalent Infanrix vaccine, GlaxoSmithKline (GSK), disclosed required information in a confidential report to the regulatory authority. In that report, which has been made public per orders by Italian Court of Justice Nicola Di Leo, according to the India Medical Times, the deaths of 72 babies took place within 20 days of getting the Infanrix hexa jab. Di Leo ordered the documents released during an autism-related hearing.

Infanrix vaccination generally follows a schedule of injections at three, five, and eleven-months of age, according to a paper published in Human Vaccines and Immunotherapeutics, which stated that the vaccine was first licensed in 2000 and that the vaccine has demonstrated a decade of safety.

Dr. Jacob Puliyel, head of pediatrics at St. Stephens Hospital in Delhi, linked to the previously confidential documents on Infanrix and commented on the Human Vaccines and Immunotherapeutics's article where it appears in the U.S. National Institute of Health's library. The pediatrics head called attention to what he believes is a strong correlation between sudden death and Infanrix when he wrote that "if one analyzes 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."
Puliyel went on to write that Infanrix hexa may have been to blame for at least 69 babies' deaths during the reporting period alone. He states that 69 of the deaths during the reporting window were investigated thoroughly and occurred within three weeks of vaccination with Infanrix and the ages of the babies varied.

Did the hexavalent Infanrix vaccine cause sudden death?
Rather than compounding the total deaths each day, as in the documents found online, the pediatrics doctor suggests we examine how many more deaths happened right after the vaccine was given compared to as the days went by. He said this demonstrates a link between the vaccination event and the sudden deaths.

"The data is conclusive. It is very clear and there is no room for argument," a child safety advocate from Child Health Safety wrote just hours after Puliyel made his analysis public.

"And the analysis is simple. Anyone can understand it. The very plain data the document contains proves the matter without any doubt whatsoever."
Claims on social media based on the doctor's published comment are snowballing.The doctor who analyzed the data did not state that there was no room for argument, though. He did not brazenly state that the hexavalent Infanrix vaccine causes sudden death in babies.

Puliyel stated that he published his commentary "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." Puliyel notes that the "decelerating incremental-deaths" support the theory of a clear relationship between deaths labelled as sudden death and "the vaccination episode." The vaccination episode includes many variables besides just Infanrix vaccination itself.

Puliyel noted a correlation between deaths and the combination vaccine Infanrix. Puliyel has been clear before, such as in his letter to the Guardian, that he believes combination vaccines are possibly dangerous and far too expensive.

"India is a country where 50% of the population, do not receive the 6 basic vaccines against diphtheria, whooping cough, tetanus (DPT), polio, tuberculosis and measles. The incremental cost of complete immunization with these vaccines is less than US $0.75 (Rupees 30) per child. Again today, I had the heart wrenching experience of explaining to a mother about the death of her 8 year old girl with diphtheria. Both the mother and my Registrar at the bed-side were distraught. 2 week ago we had another death from the same disease. The push to include expensive new vaccines must be viewed in this context. The 'pentavalent vaccine' that is being canvassed, on its own, will increase cost of DPT immunization twenty-fold [2]. It is not about lives lost in poor countries – it is all about the cash register. These organizations and their sponsors have profit margins to protect. Ethics is not a major issue with them."
The previously classified Infanrix document listed extensive details about the safety of Infanrix, and the sudden death cases were just a fraction of the issues addressed. In one of the tables, many other events were reported. These events may or may not have been caused by the Infanrix vaccine, but were disclosed to the regulatory authority. They include nearly one hundred cases of pertussis, a couple dozen cases of meningitis, 28 cases of bacterial pneumonia, about 20 cases of encephalitis, and about one hundred cases of children suddenly staring off since the launch of the vaccine in 2000. Below are some of the more frequently reported events listed within the document. Only events listed as serious were included in the graph.

Infanrix hexa is one of the safest vaccines, but there have been events reported that include death.
Infanrix hexa vaccine is given for vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenza type b and is being linked to infant death by a pediatric doctor who is concerned about combination vaccines. Other events were also disclosed in a a document that can now be found online.

Not all events reported can be definitively linked to Infanrix. Conversely, a great deal of events never get reported. GSK noted that as of the 2011 report, somewhere between 18 million and 73 million children were vaccinated with Infanrix, demonstrating just how infrequently side effects are reported after the vaccination. The year following the report, there was a recall on six batches of Infanrix, but that was issued out of an abundance of caution.

Some speculate that Infanrix is incredibly safe, but that Prevnar 13 administered with Infanrix might up the risks of a reaction, according to an article in LeSoir. That should come as no surprise though, given that GSK freely admits to increased reports of events following vaccination with both Prevnar and Infanrix in its prescribing literature.

Within the previously confidential document, a contraindication to vaccination with Infanrix noted is a hypersensitivity to any of the active substances or to any of Infanrix's excipients or residues, including lactose, polysorbate 20 and 80, glycine, formaldehyde, neomycin sulphate and polymyxin B sulphate. Reports of anaphylaxis are calculated, using information disclosed in the document to the regulatory authority, to be as rare as only four in every ten million doses. According to the statistics within the document, even if the doctor from Delhi's fears are spot on, the risk of sudden death, while existent, would also be exceptionally rare after vaccination with the hexavalent Infanrix vaccine.

This article has been corrected. In the original article, the anonymous Child Health Safety writer was described as an anti-vaccine advocate. The website's official stance is that there is no actual anti-vaccine movement, just a movement for health safety.

[Featured photo via Twitter]