The vaccines: PEDIACEL, INFANRIX hexa, ADACEL-Polio and ADACEL

1. Overview of Acellular Pertussis Vaccine
2. Overview of Haemophilus influenzae type b vaccine (Hib)
3. PEDIACEL®
4. INFANRIX hexa™
5. ADACEL®-Polio
6. ADACEL®

Overview of Acellular Pertussis Vaccine (aP)

Efficacy: From a community point of view, the concept of having your child vaccinated with pertussis vaccine in order to help protect others is a dubious one. Pertussis vaccine was first developed in 1906. It began to be widely used in the late 1940′s after pertussis toxoids were combined with diphtheria and tetanus toxoids to form DTP, the first combination vaccine. Now, after sixty years of widespread use, it’s becoming clear that pertussis vaccination programs have been brewing a human tragedy. It used to be young children who got the disease, the average age of infection being 4 to 5 yrs. Before the vaccine, mothers had often had pertussis as children and had developed immune factors (antibodies) specific to that disease. The immune factors persisted and were naturally boosted by further contact with pertussis disease. These females never contracted pertussis again and were able to pass immunity on to their offspring via the placenta before birth and breastmilk once the baby was born. ⁽¹⁾ British doctor, Jayne L M Donegon, tells us “Placental antibodies from natural infection should protect children for that vulnerable first year, particularly if combined with breast feeding”. ⁽²⁾ But immunity derived from pertussis vaccine lasts only a few years. Most modern mothers have been vaccinated as children and, while many escape the unpleasantness of pertussis, they are not able to pass on antibodies specific to pertussis. Infants are now vulnerable. As well, there are increasing numbers of pre-teens, teens and adults getting pertussis, often in a mild form similar to a bad cold or flu. In a 2002 newspaper article, Dr Karl Wirsing von Konig, director of the University of Dusseldorf Institute for Hygiene and Medical Laboratories was quoted as saying: “Irrespective of the country, mostly between 20 and 30 percent of all coughing adults actually have pertussis.” A 2003 Archives of Diseases in Childhood study by researchers from the Health Protection Agency, London, England found that babies were most likely to have been infected by parents or vaccinated siblings. Noting the sudden large increase in pertussis cases in the USA since the early 1980′s, Dayla Guris, epidemiologist at the US Centers for Disease Control, has said “There are more cases now than there were in 1945, before we had the vaccine.” According to Dr Donegon, writing in the June 2000 issue of The Informed Parent: “In 1978 the U.S. passed laws requiring proof of vaccination before school entry to increase vaccination uptake. This caused a recognizable increase in the incidence of whooping cough in that country and it has been rising ever since.”
A study published March, 2010 in Proceedings of the Royal Society of Biological Sciences provides evidence that a worldwide increase in whooping cough and US increase in its death rate may be due to an increase in Bordatella parapertussis, another species which can cause pertussis disease. Researchers found that injection of acellular pertussis vaccine appeared to help clear B. pertussis from infected mice but, at the same time, increase lung colonization by B. parapertussis 40-fold.
In an article written in 1980, British professor Gordon Stewart revealed: “In some countries like the USA and Canada, pertussis vaccine was used intensively and it was claimed that whooping cough was a disappearing disease. Nevertheless, in both of these countries, outbreaks had been reported since 1974 in which (as in the UK) 30-50 per cent of cases were fully-vaccinated.” Health Canada has told us the increase in our pertussis cases arose largely since 1990. A Sept 1, 2003 Canada Communicable Disease Report explained: “The resurgence of pertussis was not due to poor vaccine coverage: coverage has consistently been found to be over 95% for three or more doses. The increase was largely attributable to the low efficacy of the combined adsorbed diphtheria-tetanus-pertussis whole cell vaccine used in Canada between 1980 and 1997. Its efficacy has been estimated to be in the range of 20% to 60% in children. The cohort of children immunized only with this vaccine was poorly protected and constitutes the population that has been most affected since 1990.” In 1997 came the introduction of ‘Pentacel’ with its pertussis portion in a new acellular form (ie containing only parts of the cells of Bordatella pertussis) and later, in an attempt to counter the unfortunate increase in infected (and infectious) adolescents, Canadian provincial governments began to finance new programs for teens featuring yet another vaccine – ADACEL™. Health Canada pinned its hopes on mathematical modeling which “predicts that the overall incidence of pertussis in Canada will be lower in the next decade than it was between 1990 and 2000 because of the better protection in younger children vaccinated with the acellular vaccine.” However, it admitted, “The duration of protection afforded by acellular pertussis vaccines is not known”.
If you are a parent looking for lifelong protection from pertussis for your child, that first shot of pertussis vaccine can lead to lifelong vaccine dependence which still carries no guarantee of protection but, for certain, carries risks. The problem manufacturers have always had is that in order to make a pertussis vaccine very effective in producing an antibody response, significant amounts of pertussis toxin and/or toxic adjuvant material must be used. And, as always, antibody production does not equal protection; Volume 46/ No RR-7, pg 4 of the March, 28, 1997 Morbidity and Mortality Weekly Report says “The findings of efficacy studies have not demonstrated a direct correlation between antibody response and protection against pertussis disease.”

Vaccine researcher, Viera Scheibner, PhD and British professor Gordon Stewart have described how the spread of pertussis to infants, adolescents and adults was slowed for a few years in the United Kingdom when many parents stopped having their children vaccinated for fear of adverse reactions. Despite vaccination rates that had been averaging 80%, epidemics were still occurring every 3 to 4 yrs. After vaccination rates dropped below 40% in the mid-1970′s, a large epidemic followed, building gradually over a couple of years and peaking a little later than previous cycles. It caused fewer deaths than any previous pertussis epidemic, the usual age of infection having reverted back to 4 yrs. Similarly, in Sweden after vaccination against pertussis was discontinued in 1979, most new cases were in children 2 1/2 to 10 yrs old and there were no cases in infants younger than 6 mos. ⁽³⁾
From a worldwide perspective, the more shots that are given, the more likely it is that the pertussis bacterium will mutate – after all, germs like to survive, too. In fact, this has already happened. Molecular surveillance of Bordatella pertussis strains carried out in Alberta and Quebec from 1985 to 1994 showed that in those two provinces at least, new strains were emerging. ⁽⁴⁾ Starting in 1994 in the Netherlands there was a greater increase in pertussis cases amongst the vaccinated than amongst the unvaccinated. Researchers concluded that the vaccine strains didn’t match those circulating. Comparison of older samples of the bacterium with the most recent showed that at least two surface proteins had changed. Neither can current vaccines nor immunity derived from previous B. pertussis infections protect against other species of pertussis or against pertussis mutants. Due to poor and waning vaccine-derived immunity, replacement of B. pertussis by other pertussis-causing species, and provocation of B. pertussis mutation, continued vaccination with pertussis vaccine may endanger the public rather than protect it.

Jayne Donegon writes: “During infection with Bordetella pertussis, the inhaled organism sticks to the little hairs lining the air passages. It is then able to multiply and cause the inflammation, mucus, pus and ulceration that so easily block the narrow airways of young children and babies. During natural infection with pertussis, as well as the misery of the illness, IgG, 1gM and IgA antibodies are produced. These IgA secretory antibodies are crucial as they specifically stop the bacterium from sticking to the little hairs and multiplying. Vaccination against pertussis does not produce IgA antibody which is so important in protecting against further infection. It does, however produce IgE antibodies which are associated with allergic disease.”⁽⁵⁾ Which brings us to our next topic….
Risks: Because we know most adverse reactions are not reported and many VRAN members and others are convinced that their children’s serious reactions or deaths were due to pertussis vaccine, we suspect the vaccine risks to individual children are considerable. Health Canada vaccine adverse events reports accessed via the Freedom of Information Act provide concrete evidence that this is so.
Pertussis vaccines have had a long history of bad reactions. It was the whole cell diphtheria/tetanus/pertussis shot (DTP) mandated in the US in the 1970′s and 80′s that had families of affected children there on the rampage and suing manufacturers, leading to introduction of a national compensation scheme. Canada has no such scheme. For the individual child, the change from the old whole cell pertussis vaccines to acellular vaccines may have reduced direct risks since the acellular versions are made with fewer pertussis toxins. It is the toxins, not the bacteria themselves which do damage. Since vaccine safety studies are poorly designed, use relatively few trial participants, and don’t last long enough to capture all possible adverse events, we must rely on post-vaccination adverse event reports to assess risk. F Edward Yazbak, MD, FAAP, examined death statistics recorded by the US Vaccine Adverse Event Reporting System (VAERS) and found that in 1998, “There were 23 reports of infants expiring by the day following vaccination. Even without factoring in any under-reporting to VAERS, the number of infants reported to have died by the day following DTaP vaccination in 1998 is still more than the number who died as a result of whooping cough in the year 2000.” Researcher, Sandy (Mintz) Gottstein noted an overall total of 57 deaths following DTaP vaccinations were reported to VAERS for 1998. In most of these cases, other vaccines had been given concurrently. Factoring in under-reporting, the true total may have been as much as 570 or more.
Dr Yazbak continued: “When DTP was used exclusively, many studies were published regularly to convince physicians and parents that the vaccine was quite safe. The fact is that the DTP vaccine was not safe and it had to be replaced by the DTAP vaccine. Now, the CDC and vaccine manufacturers consistently downplay the side effects of DTAP vaccination. Indeed, though minor reactions following DTAP are fewer than with DTP, more serious reactions occur in rather disturbing numbers. This is supported by a report that was issued by a committee of US Scientists and published in 1987 in the Journal of the American Medical Association (JAMA). In ‘Acellular and whole-cell pertussis vaccines in Japan. Report of a visit by US scientists’, the authors stated: ‘Since the introduction of acellular pertussis vaccines in Japan late in 1981, more than 20 million doses have been administered, mostly to children 2 years of age and older. Clinical studies indicate that mild local and febrile reactions are less frequent after administration of acellular pertussis vaccines than after whole-cell vaccines. Serious adverse events with sequelae occurred in 2-year-old children at approximately the same low rate during the period 1975 through August 1981, when whole-cell vaccines were used, and during August 1981 through 1984, when acellular vaccines were used exclusively.'”
An outstanding reference on the subject of reactions to DTP vaccines is the report from the 1989 workshop on the ‘Neurologic Complications of Pertussis and Pertussis Vaccination’ by renowned neurologists, professors J H Menkes and M Kinsbourne, both experts in the field. Workshop participants noted that, when evaluating risks of the vaccine, it must be kept in mind that:

1. Vaccines of the same type vary between manufacturers.
2. For any given manufacturer, vaccines vary batch to batch.
3. Vaccines must be properly prepared and stored at the correct temperature; if this is not done, potency decreases and reactivity increases with length of time stored.

It was the consensus of the workshop that “there is sufficient experimental data to implicate both endotoxin and PT [pertussis toxoid] in adverse neurologic reactions to pertussis vaccine.” (Note that PEDIACEL®, INFANRIX hexa™, ADACEL®-Polio and ADACEL™ contain PT but not endotoxin.)
A 1982 study by Steinman which suggested a link between a history of allergies, either in the child or his/her family, and risk for pertussis vaccine reactions, noted that milk allergy may be especially conducive. Anecdotal reports of parents agree. A recommendation by Drs. Gloecker and Gobel in A Guide to Child Health, Floris Books, 2002 points to a possible connection between poor milk digestion and complications of pertussis disease. They recommend that babies under 1 yr. with pertussis be examined for rickets or a lack of calcium in their diet since these can make pertussis much more dangerous.
Listed in order of increasing severity, observed neurological adverse reactions to pertussis vaccines include irritability, persistent, unusually high pitched crying, somnolence, seizures (convulsions), a shock-like “hypotensive, hyporesponsive” state, and encephalopathy. Following is a comprehensive list of all types of severe reactions that have been associated with vaccines that contain pertussis antigens:

1. 1. Allergic hypersensitive reaction – usually occurs within minutes or an hour of the shot and may include hives, sudden swelling of the mouth or throat, difficulty breathing, hypertension and shock. It can be life threatening and requires immediate medical attention.
   2. Shock / collapse / hypotonic-hyporesponsive episode – this was described in a 1979 UCLA/US FDA study as occurring within ten hours of pertussis vaccination, usually within four. The infant/child was pale, limp and unresponsive to parents for ten to thirty-six hours. The authors stated that “Collapse or shock-like state following pertussis immunization has been reported on numerous occasions. The majority of these hypotonic hyporesponsive episodes seem to be self-limited with no residue. However, there have been reports of death from apparent shock following pertussis immunization.” This condition requires examination by a physician in a hospital emergency room.
   3. High pitched screaming or persistent crying for 3 or more hours – this begins within a few hours of the injection, often about two hours later. The scream has been described by parents as one they had never heard coming from their infant/child before. It often lasts about one hour after which the child is exhausted and quiet but restless for about half an hour. Repeat bouts of screaming followed by exhaustion occur until finally, the child falls into a deep sleep for about twelve hours. The crying is continuous for at least an hour and may last six hours or more. In either case, screaming or crying, the child is inconsolable. This is another reaction that requires immediate medical attention.
   4. High temperature – a temperature of 102 to 103 degrees Fahrenheit that is not prolonged is considered to be beneficial in the case of a natural infection. It is one mechanism our bodies use to eliminate germs. But in the case of vaccination, our bodies are not supposed to be fighting germs, ie no outward signs of infection should manifest. A high temperature following vaccination is an adverse reaction that could trigger convulsions, and, unlike a time-limited fever during natural infection, should be lowered by using an antipyretic drug and/or non-drug method. If the fever is prolonged or nears 105 degrees F a physician or hospital emergency room should immediately be contacted.
   5. Excessive sleepiness – the child lapses into a deep sleep from which she/he cannot easily be aroused, not even to feed
   6. Convulsions – these can occur with or without fever. They are spasmodic contractions of muscles that can be prolonged or interrupted by periods of relaxation, involve many muscles or be confined to a small area of the body. Petit mal convulsions involve brief impairment of or loss of consciousness. They may be so subtle that all that is noticeable is staring episodes with slight drooling. Or, eyelids flicker and the mouth twitches a little. Grand mal convulsions can be much more dramatic: all at once the child lets out a cry, loses consciousness, falls to the ground and suffers prolonged contraction of the muscles of the cranium and limbs followed by alternating relaxation and contraction. Sometimes there is incontinence and other disorders of the autonomic nervous system. The spasms soon end but the child remains in a coma for many minutes or up to half an hour; when consciousness is regained he/she is drowsy, confused and experiencing a headache. Convulsions also call for medical examination. The 2005 Pentacel® monograph stated: “High fever within 48 hours of a previous dose of vaccine, attributed to immunization and not to intercurrent illness, indicates the likelihood of recurrence of fever with subsequent doses. Febrile convulsions may be more likely in a susceptible child who develops high fever. Parents of children who may be at increased risk of a seizure after pertussis vaccination, such as from a personal or family history of seizures, should be informed of the risks and benefits of pertussis immunization in these circumstances.” Having thus placed the onus of informing about risk on those administering the vaccines, Sanofi Pasteur would no doubt have preferred that the benefits were made to appear greater than the risks. The solution they suggested for the pesky problem of possible febrile convulsion was to cover it up by using a fever-suppressing drug. In a 1987 Morbidity and Mortality Monthly Report, concerning pertussis vaccine, the US Center for Disease Control stated: “recent studies suggest that infants and children with a history of convulsions in the first degree family members [ie brothers, sisters and parents] have a 3.2 fold increased risk for neurological events compared with those without such histories.”
   7. Encephalopathy – a brain defect, signs of which include bulging fontanel (a soft diamond-shaped area on top of a baby’s head); sudden eye crossing; unusual unresponsiveness to family members or visual or auditory stimuli; inability to move an arm or leg; strange, repetitive movements of any part of the body; and a pronounced regression in physical, emotional or intellectual behaviour. Convulsions may be involved. Encephalopathy can lead to mental retardation, learning disabilities, behaviour disorders, paralysis or other mental and physical disability. Any of these symptoms shortly after pertussis vaccination calls for an immediate examination by a physician. In the weeks following vaccination, if intuition tells you something is wrong with your child’s behaviour, promptly consult a paediatric neurologist.
   8. Severe local reaction – a large, red, hard, hot lump at the injection site that may remain for several weeks. Parents have reported that such a reaction preceded a later dose which caused a systemic (ie whole body) or neurological reaction.
   9. General systemic reaction – can include a body rash, vomiting or diarrhea within hours of the shot. Or, the child may suffer a sudden decline in health by way of loss of appetite and weight (ie failure to thrive), chronic diarrhea, ear and respiratory infections or development of new allergies. Failure to thrive or chronic illness are reasons to have the child checked by a medical doctor and/or alternative therapist. A general systemic reaction may be a warning that further vaccination could result in a more severe reaction.
   10. Thrombocytopenia and haemolytic anemia – two blood disorders that have been reported rarely. Thrombocytopenia manifests as “purpura”, blotchy red patches caused by seeping blood.
   11. Diabetes and hypoglycemia – too much or too little sugar in the blood. Researchers have detected increased insulin production in infants injected with pertussis vaccine. This may lead to hypoglycemia (low blood sugar), especially where a feeding is missed due to fever or loss of appetite after vaccination. In a 1978 study, authors Hannik and Cohen reached the conclusion that “infants who show serious reactions following pertussis vaccination suffer from failure to maintain glucose homeostasis.” Immunologist Dr Bart Classen has demonstrated a correlation between juvenile insulin dependent diabetes and pertussis vaccines.
   12. Asthma and allergies – as evidenced by several studies: in 2000, a review of data gathered in the USA from 1988 to 1994 by Hurwitz and Morgenstern published in the Journal of Manipulative and Physiological Therapeutics showed increased risk of asthma and allergy-related symptoms from DTP. A 1997 retrospective study by M Verrall of 1934 patients from one British general practice published in Pulse 1/5/99 showed that pertussis-vaccinated children were 75% more likely to develop asthma, hayfever and eczema later in life. Michel Odent et al published a retrospective study in the Journal of the American Medical Assn., 1994:272:592-3 in which he showed that pertussis-vaccinated children were over five times more likely to suffer from asthma and twice as likely to have had ear infections as unvaccinated children. A 2005 study published in the journal, Vaccine, acknowledged that both aluminum adjuvant and pertussis toxin antigen can skew the immune system. It noted that each of these “promotes IgE production, which is related to allergic disease.” ⁽⁶⁾ The March, 2008 Journal of Allergy and Clinical Immunology featured a Manitoba study which showed reduced development of asthma when the first dose of DTP vaccine was delayed and an even greater reduction when all of the first three doses had been delayed. ⁽⁷⁾ Viera Scheibner PhD, who has done exhaustive research on vaccines, says medical research has shown that having had pertussis disease prevents asthma and that parents report either a marked improvement or disappearance of asthma after their vaccinated children fall ill and overcome the disease.
   13. Invasive meningococcal disease – a possible link between this and pertussis vaccination was noticed in Britain. During the period of low uptake of DTP vaccine from the mid-1970′s to mid-1980′s there was a decrease in the number of deaths of children newborn to 4 yrs old from invasive meningococcal disease and an increase as vaccination rates subsequently rose. The link is corroborated by numerous studies which show a correlation between pertussis vaccines and systemic bacterial infections of several different organisms, especially Haemophilus influenzae b. ⁽⁸⁾

Overview of Haemophilus influenzae type b vaccine (Hib)

Efficacy: The Hib portion of the 5-valent ‘Pentacel’ (DTaPIPVHib) vaccines had the unusual requirement of injection either at the same time as ‘Quadracel’ (DTaPIPV – vaccine containing pertussis, tetanus, diphtheria and polio components) but in a different location, or, in one location immediately after being combined with ‘Quadracel’. A “Medscape” article of the year 2000 explained that a combined Hib-Quadracel type vaccine had not been accepted in the USA due to an interference problem: “In 1997, the FDA rejected the application of Pasteur-Merieux-Connaught to license their DTaP-Hib (TriHIBit) for the primary series in infants because of a diminished antibody response to the Hib component when compared with the same vaccines administered separately.” ⁽⁹⁾
The 1998 Pasteur-Merieux-Connaught Pentacel™ monograph and 2002 Aventis Pasteur Pentacel® monograph stated: “Data on whether vaccination prevents acquisition and carriage of Hib are still limited. Thus, rifampin or other appropriate chemoprophylaxis should be used, in accordance with the usual recommendations, for families and persons in day-care centers in which a case of invasive Hib disease has occurred and in which there are one or more contacts less than 48 months of age who have not been fully vaccinated against Hib.” This makes us wonder if the fall in Hib disease that has occurred since Hib vaccination began may be due more to chemoprophylaxis than to the vaccine.
Risks: What is known is that, as Hib cases diminished, cases of pneumococcus rose; just as pertussis vaccines surely provoked an increase in Hib and other bacterial diseases, it appears that Hib vaccine has provoked an increase in pneumococcal disease. A June, 1992 ‘Newsletter’ from the Journal of Pediatric Infectious Diseases stated: “We have great concern for the increasing prevalence of relatively or absolutely penicillin-resistant pneumococci coupled with the increased relative frequency of pneumococcal diseases as a result of universal Haemophilus vaccination.” This is most unfortunate since pneumococcal disease is much more serious and antibiotic-resistant than Hib has ever been. ⁽¹⁰⁾ By 2002, Public health’s answer to the problem was to introduce yet another provocateur of pathogens: PrevnarTM, a 7-valent (ie having 7 different bacterial strains) pneumococcus vaccine for children. Subsequently, in 2009, PNEU-C-10 (10-valent pneumococcal vaccine) was introduced; by 2010, PNEU-C-13 was being recommended for Canadian babies.

But not only that, we also have evidence that Hib vaccine is provoking redistribution of the various strains of Haemophilus bacteria. In the January 1, 2003 issue of the Journal of Infectious Diseases, Ribeiro et al describe the results of disease surveillance in Salvador, Brazil before and after the introduction of Hib vaccine there. In the first year after introduction, Haemophilus influenzae type b meningitis decreased by 69% but Haemophilus influenzae type a meningitis increased 800%. The authors concluded “Hib immunization contributed to an increased risk for influenzae type a meningitis….these findings highlight the need to maintain surveillance as the use of conjugate vaccines expands worldwide.” A study by Omikunle et al published April 2002 in the Journal of Clinical Microbiology found that, in Tennessee, “Invasive infections caused by non-type b encapsulated Haemophilus influenzae have increased in frequency in the last decade.” In 2000, M Gonzalez Lopez et al, working at the Hospital Materno Infantil de Malaga, Madrid, studied the case of a 5 mos old boy who’d been vaccinated twice with Hib but developed influenzae type f meningitis. They concluded: “An adequate epidemiological surveillance system would be helpful in detecting the role of these non-b Hif serotypes as significant pathogens, which appear to be on the increase.” Sarangi et al, working in England, had their study about invasive Haemophilus influenzae disease in adults published in the June 2000 Epidemiology of Infection. They discovered that “After the introduction of Hib immunization in children, invasive Hib infections in unimmunized adults also declined, but the overall rate of invasive Hib disease in adults increased, with most infections now caused by non-capsulated strains.” Working in Queensland, Australia, Pincus and Robson described a case of influenzae type f meningitis in a Hib-vaccinated 3 yr old in the Feb, 1998 Pediatric Child Health. They concluded: “Despite the great success of Hib vaccines in reducing invasive disease due to H. influenzae, cases of H influenzae meningitis continue to occur, caused by less common encapsulated serotypes. Whether there will be an increase in the number of these cases in the vaccine era is unknown and infection due to non-b serotypes requires close monitoring.”
The 2002 Aventis Pasteur Pentacel™ monograph noted that, “Because the vaccine will not protect against non-typeable strains of H. influenzae which cause recurrent upper respiratory disease, otitis media [earache] and sinusitis, the vaccine is not recommended for these conditions.” We wonder if Hib vaccine has, in fact, produced an upsurge in these illnesses by provoking an increase in these non-typeable strains.
The 2002 Pentacel™ monograph also stated: “Physicians should be aware that recipients of Haemophilus b vaccine are not protected against Hib disease in the week after vaccination”. This “unprotected” period following vaccination was first discovered at the beginning of the twentieth century by Almoth Wright, inventor of the typhoid vaccine. With that vaccine he noticed an unprotected period of weeks to months, during which time infections were more likely than before the vaccine was injected. ⁽¹¹⁾

One adverse reaction from Hib vaccine that needs serious consideration is insulin dependent diabetes (IDDM). A study published in Autoimmunity, Vol. 35 No 412002, pgs 247-253 found a significant increase of cases of IDDM in a large population of Finnish children compared to controls three years after they had received four doses of Hib vaccine. This vaccine was also found to increase IDDM in mice. In 2000, one of the authors, immunologist Bart Classen, had presented data which showed Hib vaccine increased the risk of getting IDDM by 25%. Considering pertussis, tetanus and diphtheria vaccines also increased the risk by 25%, 20% and 9% respectively, the cumulative risk from these four vaccines, all present in PEDIACEL® and INFANRIX hexa™ may make them main contributors to childhood diabetes. Links to a multitude of current and past research on the topic of the association of vaccines with diabetes can be found on Dr. Classen’s website.
Following many years of research, Rita Hoffman, a VRAN member whose son developed life threatening allergies after his childhood vaccinations, has concluded that it was the Hib vaccine he was injected with that was the ultimate cause of his illness. She and other parents and teachers have noticed that there was a surge of anaphylactic children entering schools in Ontario around 1990, shortly after introduction of the first Hib vaccination programs. By 2001 approximately 4% of Canadian children had a potentially lethal food allergy. Rita cites study after study which connects allergies and anaphylaxis to Hib vaccine as well as pertussis vaccine, aluminum adjuvants and multi-valent vaccines. She’s discovered that nut oils may be used as vaccine adjuvants. However, when Health Canada was asked for complete lists of all vaccine ingredients, they replied these couldn’t be disclosed due to a “mandatory exemption which protects confidential business information.” What this means is that the Canadian government is more interested in protecting the rights of vaccine manufacturers than in protecting the rights of health consumers to fully informed consent. Rita Hoffman gives a small glimpse into what anaphylaxis involves: she says, “living with anaphylaxis is to be continually on guard for minute quantities of everyday food or other substances that may cause death. Keeping anaphylactic children safe involves the whole community including the child, parents, teachers, bus drivers, caregivers, friends and family.”

References for Overviews

1. 1. 1. Immunization: History, Ethics, Law and Health, 1999, by Catherine J M Diodati, MA.
      2. “Whooping Cough: The Disease and the Vaccine”.
      3. VRANewsletter, Fall 2003: ‘Message to Autism Conference’ by Viera Scheibner, PhD.

Here’s Health, March, 1980: “Danger” by Professor Gordon Stewart (also on Whale).

• National Consensus Conference on Pertussis, April, 2003; Health Canada Canada Communicable Disease Report Vol 129 S3: presentation by Dr Mark Peppler.
• “Whooping Cough: The Disease and the Vaccine” by Dr. Jayne L. M. Donegan.
• Vaccine; T Sugai et al; A CpG-containing oligodeoxynucleotide as an efficient adjuvant counterbalancing the Th1/Th2 immune response in diphtheria-tetanus-pertussis vaccine.; Vol 23, Nov 16, 2005.
• Journal of Allergy and Clinical Immunology; Kara L McDonald, MSc et al; Delay in diphtheria, pertussis, tetanus vaccination is associated with a reduced risk of childhood asthma.; Vol 121, Issue 3, pgs 626-631, March, 2008.
• Vaccination: 100 Years of Orthodox Research shows that Vaccines Represent a Medical Assault on the Immune System, 1993, by Viera Scheibner, PhD; pgs 38-46.
• “Rocky Road to Combination Vaccine Licensure — Statistical Data Included“.
  Combo Vaccine Rules Too Strict – Brief Article.
• “The Perilous Haemophilus, or is it …Pneumonia“, July, 1996, by Hilary Butler for the Immunization Awareness Society.
• Immunization: History, Ethics, Law and Health; pgs 80-81.
• VRANewsletter, July-Oct 2000, pg 27: ‘CDC Supports Causal Relationship Between Vaccines and Diabetes’

PEDIACEL®

This five-valent vaccine is used for infants and children, 2 months to six years old. Like the ‘Pentacel’ vaccines, PEDIACEL® contains antigens (immune stimulants) of diphtheria, tetanus, pertussis, polio and Hib. But, unlike ‘Pentacel’, its Hib antigens have been pre-mixed with the others. Vero cells (kidney tissue of the African Green Monkey) are used to grow the three types of polio virus in PEDIACEL®. Although this particular type of monkey tissue generally isn’t contaminated with the notorious SV40 monkey virus which was found in the early polio vaccines, it can harbour other viral contminants.
PEDIACEL® contains the same chemicals, bovine serum albumin contaminant and antibiotics as did ‘Pentacel’ but it also contains traces of a third antibiotic, streptomycin. The main chemical ingredients are the adjuvant, aluminum phosphate, 2-phenoxyethanol and polysorbate 80; formaldehyde is present in trace amounts. (Please see our ‘Vaccine Ingredients’ section for further information about these.)
According to the 2007 PEDIACEL® monograph, four clinical trials were used to gain licensure of the vaccine: a Swedish efficacy and safety trial in which 2, 587 infants received it; another Swedish trial in which 20,728 received it but only efficacy was studied; and two very small Canadian efficacy and safety trials with only 339 and 112 infants/toddlers receiving PEDIACEL. It’s questionable how valid the Swedish data is for judging the suitability of a vaccine to be used in a country with a different racial and cultural mix and different environmental problems and other stress factors. The trial which began with 339 two month old babies receiving PEDIACEL ended with only 300 eighteen month old babies receiving it. A table of solicited adverse events occurring within 24 hrs of vaccination shows that injection site reactions were more frequent by eighteen months. The most frequent solicited systemic reactions were fussiness, crying, less activity, and fever greater or equal to 38 degrees centigrade.
Worldwide post-marketing experience with the vaccine has shown immune, nervous and vascular disorders and what the monograph calls “psychiatric disorders”. Under the latter heading is “screaming”. Why it was decided that screaming was due to a mental disorder and not a physical one (eg vaccine-induced encephalitis) is not explained. The monograph notes that, “A review by the IOM [US Institute of Medicine] found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome.” Most of the conditions listed above in the ‘Overview of Acellular Pertussis Vaccine’ as adverse events from vaccines containing pertussis antigens are listed in the PEDIACEL® monograph as reported adverse events. Considering these reports, of interest is the monograph’s quote of advice from the National Advisory Committee on Immunization NACI) that, “Simultaneous administration [with other vaccines] is suggested, particularly when there is a concern that a person may not return for subsequent vaccination.” The monograph also reveals, “Sudden infant death syndrome (SIDS) has occurred in infants following administration of DTaP vaccines.” But, as if to completely disassociate their vaccine from infant death, Sanofi Pasteur advises, “By chance alone, some cases of SIDS can be expected to follow receipt of PEDIACEL®.
Several warnings and precautions are given and suggested in the monograph. Those administering the vaccine must be sure it’s injected into muscle only, and not a blood vessel or the buttocks. “Antigenuria [presence of a specific antigen in the urine] has been detected in some instances following administration of a vaccine containing Hib antigen. Therefore, urine antigen detection may not have definite diagnostic value in suspected H. influenzae type b disease within two weeks of immunization” (We wonder if this vaccine-induced antigenuria is sometimes used as a convenient excuse to dismiss Hib vaccine failure.) There is a concern that, “According to NACI, immunocompromised persons (whether from disease or treatment) may not obtain the expected immune response. If possible, consideration should be given to delaying vaccination until after the completion of any immunosuppressive treatment. Nevertheless, vaccination of persons with chronic immunodeficiency such as HIV infection is recommended even if the antibody response might be limited.” Considering so many children’s immune systems are compromised today, this could be reason enough to forego vaccination in favour of avoiding risks. And, as we’ve said previously, allergies and asthma can arise as a result of vaccination, so vaccinations are likely diminishing their only benefit.

INFANRIX hexa^TM

This vaccine, manufactured by Glaxo Smith Kline (GSK), is an alternate to vaccinating with Pediacel™ plus Recombivax HB®. It contains Hepatitis B vaccine as well as the five vaccines that are in Pediacel™ and is licensed for use in babies 6 weeks-2yrs old. (Please refer to the section on Hepatitis B vaccine to learn about it and the disease, Hepatitis B.) As well as the disease-associated antigens, the July, 2008 INFANRIX hexa^TM product monograph lists the following ingredients: lactose, sodium chloride, aluminum salts, formaldehyde, polysorbate 20 and 80, M199, potassium chloride, disodium phosphate, monopotassium phosphate, glycine, neomycin sulphate and polymixin B sulphate. More information on these can be found in the ‘Vaccine Ingredients’ section of our website.
In a US trial in which 134 infants received a first-time (“primary” or “priming”) injection of ‘INFANRIX hexa’, within eight days of injection 83% displayed irritability/fussiness. They had injection site reactions, fever, diarrhea, reduced appetite, and less or more sleep than usual at rates of 36% to 63%. “Unusual crying for more than one hour occurred in 43%. Regarding subsequent injections, the monograph reveals: “As has been observed for DTPa and DTPa-containing combinations [ie vaccines with acellular pertussis antigens], an increase in reactogenicity and fever was reported after booster vaccination with INFANRIX hexa with respect to the primary course.”
Post-marketing adverse events have included: disorders of the blood and lymph, allergic and anaphylactic reactions, collapse, hypotonic-hyporesponsive episode, apnea (breathing stopped), skin disorders, and extensive swelling including swelling of the entire injected limb. The monograph suggests that a fever-suppressing drug should be given when INFANRIX hexa^TM is administered at the same time as the pneumococcal vaccine, PREVNAR®, since a higher incidence of fever, including that above 39.5 degrees Centigrade has occurred when the two are co-administered. But adding another drug to the two others would further decrease the body’s stores of Vitamin C, increasing a slim possibility that broken bones, retinal hemorrhage and a fallacious diagnosis of Shaken Baby Syndrome (SBS) would ensue.(see the SIDS/SBS sub-section of ‘Health Risks”)
GSK’s monograph states: “While acute encephalopathy and permanent neurologic damage have not been reported to be causally linked nor in temporal association with administration of INFANRIX hexa^TM, data is limited at this time.” It continues, “Studies suggest that when given whole-cell DPT vaccine, infants and children with a history of convulsions in first-degree family members (i.e. siblings and parents) have a 2.4-fold increased risk for neurologic events compared to those without such histories.” As well as “unusual” neurologic events, the monograph admits, “Extremely rare cases of Sudden Unexpected Death (SUD) [otherwise known as SIDS] in close temporal association to vaccination with INFANRIX hexa^TM have been reported in the first year of life.”
We find it disconcerting that the monograph admits, “INFANRIX hexa^TM has not been evaluated in the Canadian Native Population.” Does this mean the Canadian First Nations population or the non-immigrant population of Canada as a whole? The only vaccine trial populations named in the monograph are Americans, Italians and Germans.
GSK warns, “As for all diphtheria, tetanus and pertussis vaccines, each injection should be given deep intramuscularly and each injection of the immunization series should be made at a different site.” Considering the limited areas of baby muscle and the number of vaccinations scheduled, the latter could pose a problem.
Information lacking for this poorly-studied vaccine includes possible interactions with foods, herbs and lab tests. These, says the monograph, “have not been established.”

ADACEL®-Polio

This vaccine was approved for use in Canada in April, 2011. Like Sanofi Pasteur’s Quadracel® vaccine, their Adacel®-Polio is meant to prevent diphtheria, tetanus, pertussis and polio. But, compared to the concentrations of the pertussis-related and diphtheria toxoid antigens in Quadracel® (DTaP-IPV), those in Adacel®-Polio (Tdap-IPV) are greatly reduced.
Tetanus, diphtheria, and pertussis components of Adacel®-Polio have been grown on media containing casamino acids derived from the allergenic milk protein, casein. Even if a child doesn’t have an allergy to casein prior to vaccination, he/she could develop it due to injection of this contaminating protein. As well as the disease-related antigens, the ADACEL®-POLIO monograph lists the following ingredients: aluminum phosphate, 2-phenoxyethanol, polysorbate-80, bovine serum albumin, formaldehyde, glutaraldehyde, streptomycin, neomycin and polymixin B. (see ‘Vaccine Ingredient‘ section for details about these)
Some of the reactions frequently observed in children 3-5 yrs old during clinical trials were pain (46.5% to 71.3%), tiredness (35.7% to 52.7%) and redness and swelling (20.4% to 48.7%). Adverse events reported post-marketing have included disorders of blood, lymph, muscles, connective tissue, and of the immune and nervous systems. Also reported has been “Extensive limb swelling, which may extend from the injection site beyond one or both joints and is frequently associated with erythma [skin inflammation], and sometimes with blisters…The majority of these reactions appeared within 48 hours of vaccination and spontaneously resolved over an average of 4 days without sequelae.” Nevertheless, notices to Ontario and New Brunswick health professionals stated that, as of May 2012, Adacel®-Polio (Tdap-IPV) would replace Quadracel® (DTaP-IPV) for the preschool booster (fifth) doses of diphtheria, tetanus, pertussis and polio vaccines. One of the reasons given was that “Adacel®-Polio is associated with fewer large injection site reactions than Quadracel®.”!
A notice to health providers in Manitoba notes that the increased reactions from Quadracel® might be due to its higher concentration of pertussis antigens. But this concentration, and presumably the reactions, have been unchanged since Quadracel® was introduced into Canadian vaccine schedules in 1997. Why is it only since Adacel®-Polio with its reduced concentration has become available that, all of a sudden, health authorities are admitting a concern re adverse events and changing recommendations?
Perhaps they’ve been overlooking another problem. Page 11 of the monograph has a table from the National Advisory Committee on Immunization (NACI) which shows their recommendations for wound management with passive Tetanus immune globulin vaccine (TIG) which contains ready-made human immune factors, and the active Tetanus toxoid (Td) vaccine which is intended to stimulate production of antibodies. Note that both the passive and active vaccines can be used as prophylactics; the passive type is reserved solely for patients who’ve been wounded, the active type is usually given with the intention of preventing tetanus toxoid effects in possible future wounds. The table indicates that, in general when a wound occurs, 3 doses of Td is considered sufficient for prevention of these effects without use of TIG. Because of this, we wonder if children who receive four doses of Td in the recommended Pediacel® or Infanrix hexa™ infant/toddler vaccines followed by a fifth dose in Adacel®-Polio are being over-dosed even according to NACI standards which aren’t known for limiting vaccines!
In their Adacel®-Polio monograph, Sanofi Pasteur admits that, “Because of waning immunity, many vaccinated children become susceptible to pertussis in adolescence or adulthood.” They fail to declare that what they call “immunity” is merely a measure of pertussis antibodies which nowhere near represents the immunity produced by pertussis infection. Nevertheless, despite the “waning”, so-called “immunity” after five doses of pertussis vaccine, they persist in promoting their product by advising that the vaccine-friendly NACI recommends pertussis vaccine for adolescents and adults to protect themselves and “indirectly protect susceptible infants” (who would likely not be susceptible if their mothers hadn’t been vaccinated but had been exposed to pertussis infection prior to pregnancy). Then they have the gall to inject more fear by adding, “Pertussis is a frequent cause of cough illness with significant morbidity in adolescents and adults.”

ADACEL®

This vaccine is given as a single dose booster to people 4 to 64 yrs old. Manufactured by Sanofi Pasteur, it contains immune-stimulating antigens against diphtheria, tetanus and pertussis, the latter being in acellular form. Other ingredients are: aluminum phosphate, 2-phenoxyethanol and trace amounts of formaldehyde and glutaraldehyde. (see ‘Vaccine Ingredient’ section for details about these)
During clinical trials, pain was the most frequent adverse event noticed within fourteen days of injection. It occurred in 78% of adolescents, 68% of adults and 40% of children. Other frequent events were: headache in 44% of adolescents and 34% of adults; erythema (inflammation of the skin) in 35% of children, 21% of adolescents and 25% of adults; tiredness in 32% of children, 30% of adolescents and 24% of adults; body ache or muscle weakness in 30% of adolescents and 22% of adults; swelling at the injection site in 24% of children and 21% of both adolescents and adults; anorexia in 22% of children.
Adverse events realized post-marketing included: hypersensitivity reaction (anaphylaxis with angiodema, edema, rash, hypotension); parasthesia; hypoesthesia; Guillain-Barré syndrome; brachial neuritis; facial palsy; convulsions; syncope (fainting); myelitis; myocarditis (heart inflammation); pruritus; urticaria (hives); myostis (muscle inflammation); muscle spasm; and extensive limb swelling which took 3-5 days to resolve.
The 2009 ADACEL® monograph discusses the safety of injecting other vaccines at the same time as ADACEL®. For concomitant vaccination of both FLUZONE® inactivated influenza vaccine in adults 19-64 yrs old and RECOMBIVAX® hepatitis B vaccine in adolescents 11-12 yrs old, it spins: “The safety and immunogenicity profiles were comparable to those observed when the vaccines were given on separate occasions one month apart.” All this tells us is that, no matter whether the vaccinations were spaced apart or not, the risks were much the same. The comparisons that should have been made are those between the safety of receiving an injected placebo (ie no vaccines), the safety of receiving only ADACEL® and the safety of receiving ADACEL® plus one or more other vaccines.
Sanofi Pasteur’s monograph emphasizes, “It is extremely important that the recipient, parent or guardian be questioned concerning any signs or symptoms of an adverse reaction after a previous dose of vaccine.” Regarding route of injection, the monograph warns that ADACEL™ must be given only by intradermal injection, no other route, and should not be injected in the buttocks. It also warns, “The effect of ADACEL® on the development of the embryo and fetus has not been assessed. Vaccination in pregnancy is not recommended unless there is a definite risk of acquiring pertussis.” Without any consideration of risks from the chemicals and contaminants in the vaccine, the monograph continues, “As the vaccine is inactivated [its antigens are not alive], risk to the embryo or the fetus is improbable.” Similarly, it contends that, even though the effect of ADACEL® during lactation hasn’t been assessed, any risk to a nursing infant is also “improbable”.