Canadian babies starting their vaccine schedule are first injected with:

PENTACEL™ VACCINE: DTaPIPVHib

(used against Diphtheria, Tetanus, Pertussis (Whooping Cough), Polio and Haemophilus influenzae type b)

The June 2002 Aventis Pasteur monograph for Pentacel says it can be injected into infants and toddlers at 2, 6, and 8 months of age followed by a booster shot at 18 months. If delayed, it can be given no later than 7 yrs old. A booster dose of Quadracel™, ie: Pentacel minus Haemophilus, can be given at the time of school entry at 4 to 6 yrs but is unnecessary if the booster dose of 'Pentacel' has been delayed until after the 4th birthday. Pentacel contains: the toxoids, (ie weakened toxins), of diphtheria and tetanus; a five-component pertussis vaccine which includes pertussis toxoid and parts of the bacterium, Bordetella pertussis; a three-virus polio vaccine and a conjugate Haemophilus bacterium vaccine (ie one in which a portion of the H. bacterium is bound to tetanus protein). After injection, these eleven pathogenic antigens theoretically produce an immune response and subsequent immune "memory" in the body such that the infant/child will be resistant to future invasions by the disease pathogens they represent.

Obviously, Pentacel vaccine is a highly artificial vector and possible means of gaining immunity. It is extremely unlikely that, under natural conditions, a person would come into contact with all these antigens at once. In fact, except via vaccination, it's unlikely they would contact them at all.

Pertussis disease

Of all the pathogenic antigens in Pentacel, it is perhaps the pertussis components about which you will find it most difficult to come to a decision. Pertussis, commonly known as whooping cough, is a significant disease in children and can be very serious and sometimes fatal in infants younger than 6 months. But due to things such as improved sanitation, the widespread availability of fresh, unspoiled, nutritious food, the use of antibiotics, modern methods of resuscitation and rehydration techniques, death is much less likely now than it was during or before the early part of the twentieth century. Pertussis can cause severe symptoms, some of which may be permanent. Pertussis vaccine can cause similar symptoms and reactions: high fever, convulsions, continuing seizures, mental retardation, learning disabilities and chronic illness. It has also caused deaths.

Several different pathogens mimic symptoms of pertussis including Bordatella parapertussis and B. holmseii and others such as influenza; if initially there is only a dry, persistent cough, this may be misinterpreted as an allergic reaction. Therefore, if confirmation is needed, testing has to be done. After an incubation period of 5-21 days, usually 7-14, the first signs of illness range from a minor cold and cough to symptoms similar to those of bronchitis or influenza: runny nose, sneezing, a dry cough, a slight fever and lack of appetite. These symptoms last another 10-15 days. It is during this period that a sample of excretions of the nose/throat must be taken if culture testing is to be done; by the time the illness has progressed to the characteristic "whooping" stage it is too late to sample. The "whoop" of pertussis disease is the noise made when the child draws in air following coughing spells lasting up to thirty seconds. These prolonged spells serve to bring up mucous from the bronchial tubes. If food has been eaten, it may be expelled along with the mucous. The cough causes wakefulness at night and the restriction of breathing it causes may give rise to panic. The "whooping" stage may last 20-30 days and it is during this stage of the entire 4-6 weeks of symptoms that the child especially needs a calming adult nearby. Fever during the "whooping" stage is abnormal and requires the attention of a health professional. During the last couple of weeks the "whoops" become less frequent, the child starts to regain weight lost and sleep becomes easier. However, up to a year after recovery a cough, cold or exposure to cigarette smoke may set off a series of "whoops". Babies less than 3 months find it especially difficult to manage the coughing fits; they may develop cyanosis, a bluish colouring of the skin due to lack of oxygen in their blood. Complications such as pneumonia are more likely at this age. If known cases of pertussis are occurring in your area it is wise to ensure isolation of your baby from possible contacts and/ or limit any infection that may have begun with a prescribed antibiotic, usually erythromycin. ⁽¹⁾

Since the bacterium associated with pertussis is spread by airborne droplets, the disease is contagious whenever there is coughing but the most infectious coughs are the milder ones, before the "whoops" begin. Pertussis is also spread through contact with items the ill person has contacted. For more on pertussis and treatments, refer to 'Pertussis in a small unvaccinated community' and 'Pertussis Remedies' included in this package. The book, 'The Vaccination Dilemma' edited by Christine Murphy provides excellent guidance.

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 more than half a century of widespread use, it is 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 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. ⁽²⁾ 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". ⁽³⁾ 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 the immune factors 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 graph shows the death rate from pertussis in British Columbia prior to introduction of DTP and widespread use of pertussis vaccine starting in the late 1940's. After a period of no deaths from 1975-88, a slight increase is noticeable starting in 1989.

In an article written in 1980, British professor Gordon Stewart says: "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." Today, Health Canada tells us the increase in our pertussis cases arose largely since 1990. In a Sept 1, 2003 Canada Communicable Disease Report they explain: "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, in an attempt to counter the unfortunate increase in infected (and infectious) adolescents, Canadian provincial governments are now beginning to finance new programs for teens featuring yet another vaccine - AdacelTM, dTap vaccine for adolescents. (The lower case "d" and "p" signify lower amounts of diphtheria and pertussis antigens than in the childhood vaccine.) Health Canada pins 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 admits: "The duration of protection afforded by acellular pertussis vaccines is not known".

So, 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. In the Pentacel monograph only one study is cited for a claimed efficacy rate of 85.1% (meaning 85.1% of test subjects produced antibodies against pertussis). However, this must be considered the highest possible rate since the study, by Gustafsson et al published in 1996 in the New England Journal of Medicine, used only healthy subjects. 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. ⁽⁴⁾

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. ⁽⁵⁾ 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 infections protect against pertussis mutants; when the bacterium changes form rapidly and/or very significantly, none of us will be immune. Considering poor and waning vaccine-derived immunity and vaccine provocation of mutation, counter to standard beliefs, to a very large extent, continued vaccination with pertussis vaccine endangers the public rather than protects it.

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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." ⁽⁶⁾ 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.

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, including those done on Pentacel are poorly designed, the most reliable way to evaluate risk is to look at post-vaccination adverse reports. Since Canada's reports are kept hidden, we look at reports in the USA. 'Red Flags Daily' columnist, F Edward Yazbak, MD, FAAP, examined death statistics on 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 noted a 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 was more likely to have been 570 or more .

Dr Yazbak continues: "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 Society (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 on 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 toxin] in adverse neurologic reactions to pertussis vaccine." ( Note that Pentacel does not contain 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. 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/USFDA 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.
   
   The manufacturer of Pentacel states that there is no data available on effects of acellular pertussis vaccine on children who have had hypotonic-hyporesponsive episodes. They suggest the vaccine should not be given to such children.



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.
   
   While the Pentacel monograph says that a family history of convulsions is not a contraindication to administering a pertussis vaccine according to schedule, it warns that children with such a family history are at greater risk for seizures following vaccinations which produce fevers. The solution they suggest is to cover up a possible problem by using a fever-suppressing drug. They do suggest withholding the vaccine from children with a progressive, evolving or unstable neurological condition, including seizures. But their concern is not that 'Pentacel' might further damage such children, but rather that their product might get a bad reputation by reason of neurological damage in a recently vaccinated child and consequent "confusion about causation". VRAN members and others whose children have suffered neurological damage post vaccination believe there is no confusion and that the cause of the damage is clear. The caveat should also extend to children whose family member(s) has/have a history of convulsions or neurological disease. Many European countries have advised this, and 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." Recently, 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. 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. ⁽⁷⁾

Warning: if your child becomes seriously vaccine damaged or worse, the reaction will likely be called "a coincidence" and even if acknowledged, you are very unlikely to receive compensation.

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Diphtheria and its vaccine

The Pentacel monograph tells us that "Routine immunization against diphtheria in infancy and childhood has been widely practiced in Canada since 1930….fewer than 5 cases are now reported annually in Canada." As for pertussis, measles and scarlet fever, the death rate for diphtheria in North American children was steadily decreasing long before widespread vaccination was practiced. ⁽⁸⁾

According to the monograph, the diphtheria toxin is "detoxified with formaldehyde" to produce the toxoid for the vaccine. It warns "Frequent booster doses of tetanus or diphtheria toxoids in the presence of adequate or excessive levels of tetanus or diphtheria antitoxins have been associated with increased incidence and severity of reactions and should be avoided." If you are considering having your child vaccinated, this is further reason to have your child's immune status determined before proceeding. The monograph continues "Following booster doses, local erythema (skin inflammation) and swelling are not uncommon and Arthus-type sensitivity (sudden red, painful swelling with bleeding and tissue death at injection site) may occur." Rare cases of urticaria (skin eruption in various shapes and sizes) have been reported. Influenza-like symptoms may occur, usually within 12 hrs of injection with diphtheria and tetanus toxoids. Rare neurological complications such as peripheral neuropathies and demyelination of the central nervous system have been documented.

To learn more about diphtheria and its vaccine please read 'Diphtheria and Tetanus Vaccination' by Sherri Tenpenny, DO, included in this package.

Tetanus and its vaccine

Tetanus differs from other childhood diseases for which there is a vaccine because it is caused by a bacterium which cannot live and reproduce in the presence of oxygen and therefore is not communicable. In fact, Clostridium tetani, the bacterium which releases the toxin that can cause tetanus can be found in our own bodies and yet not cause infection. And even if infection does develop, contrary to what you have likely been told, it usually doesn't end in death.

Like diphtheria toxoid, tetanus toxoid is made by "detoxification" using formaldehyde. The Pentacel monograph states: "The following neurologic illnesses have been reported as temporally associated with some vaccines containing tetanus toxoid: neurological complications including cochlear lesion, brachial plexus neuropathies, paralysis of the radial nerve, paralysis of the recurrent nerve, accommodation paresis, and EEG disturbances with encephalopathy (with or without permanent intellectual and/or motor function impairment)." Other risks have already been stated in the section above on diphtheria.

The Pentacel monograph tells us that "Immunization is highly effective, provides long-lasting protection, and is recommended for the whole population." It also tells us that only 2 to 3 cases of tetanus per year are reported in Canada. We suggest you read the illuminating articles included in this package: 'Tetanus' by Magda Taylor and 'Diphtheria and Tetanus Vaccination'.

Polio and its vaccine(s)

As for tetanus, the dangers of polio are overrated, firstly because presence of polio virus in the body generally doesn't result in symptoms and even when it does, the infection is usually non-paralytic, is mild and is self-limiting to the extent that it is difficult to imagine it being the same disease that has gained the infamous reputation. In fact, because it's generally such a mild disease, it's quite possible that disease due to polio virus disappeared in Canada and elsewhere largely because of increased human resistance to the virus over generations of exposure rather than any vaccination programs. As environments in developing parts of the world began to become more sanitized in the late 18th and early 19th centuries, opportunities for exposure to polio viruses diminished and epidemics arose. But even during major epidemics, less than 10% of those exposed had any symptoms and, of those, most were no more severe than the symptoms of a cold. Less than 1% developed paralysis; only half of those remained permanently paralyzed and only 3/8% (three-eighths of one percent) of all those exposed developed severe lifetime paralysis. ⁽⁹⁾ An interesting aspect of the history of polio is that it's also quite possible that much of the disease that was thought to have been due solely to viruses was actually due to or encouraged by other factors including: intoxication from agricultural chemicals that have since been banned; lack of iodine (prior to its addition to salt); tonsillectomies which were very much "in fashion" during the years of the polio epidemics in the 1950's; lack of breastfeeding, it having gone "out of fashion", and its replacement with DDT-laced cow's milk formula. ⁽¹⁰⁾ It is interesting to note that, while DDT was phased out in Canada in 1968, it is still widely used in developing countries where polio occurs and these countries are the targets of frequent "eradication" campaigns using the live oral polio vaccine which itself can cause polio.

The second way in which the threat of polio is overrated is that, with the exception of rare cases due to importation from other countries where polio epidemics still occur, Canada has not had polio for decades. Health Canada's website tells us that the last case of home-grown wild (ie: not from vaccine) paralytic polio in Canada occurred in 1977. There were imported cases reported in 1978 and 1988 and two detections of imported wild virus that didn't cause illness in 1993 and 1996. Canada, along with the rest of the American Region, was formally certified as polio-free in September 1994.

The manufacturer's monograph states that the polio vaccine contained in Pentacel has been inactivated using formalin, a liquid version of formaldehyde. Its viruses have been cultured in human diploid cells (from an aborted foetus). For more on polio vaccines, their dubious efficacy and their risks, we highly recommend the enclosed article, 'Polio Perspectives' by Edda West.

Haemophilus influenzae type b

When it was first discovered, Haemophilus influenza type b (hereafter called "Hib") was thought to be the pathogen that caused influenza, hence its confusing name. Hib is actually a bacterium which can lead to invasive diseases, particularly bacterial meningitis, and has been the major form of bacterial meningitis affecting children under 5 yrs. It is spread by respiratory excretions through coughing and sneezing and by direct or indirect contact. The most common early symptoms of Hib disease are high fever, headache and vomiting; infants become irritable, inactive, feed poorly and vomit. Symptoms of Hib meningitis progress to a stiff neck or back; when this happens emergency medical attention is necessary. If not attended to promptly, a swift progression of symptoms can follow: convulsions, confusion, shock, coma and death, all within a few hours of the onset of symptoms. Aside from meningitis which can occur in 50-65% of all cases, complications of Hib disease include: epiglottitis (inflammation of the flap that closes off the windpipe when swallowing), affecting about 15% of children with Hib disease; septic arthritis (fever and joint inflammation), about 12%; cellulitis (skin infection), about 10%; pneumonia, about 15%; osteomyelitis (bone infection), about 3-4%; and bacteremia (blood infection), about 2-3%. When antibiotics became widely available in the 1950's and '60's they were used to stop contagion and greatly reduce deaths. However, since children who recovered from Hib disease often had severe illness including mental retardation and epilepsy, it was deemed necessary to have a Hib vaccine. Several vaccines were developed and some abandoned before the one used in Pentacel was introduced in 1992. ⁽¹¹⁾

Despite the long list of illnesses possible from Hib, research has shown that it resides harmlessly in the noses, throats and respiratory tracts of up to 90% of all healthy people; it is thought that most children have achieved such colonization and immunity by the time they are 5 yrs old. ⁽¹²⁾ At the beginning of the twentieth century Hib disease was rarer than it was in the latter half of the that century when the number of vaccines given and rates of vaccination soared. In her 1993 book, Viera Scheibner asks "Why have developed countries experienced such an increase of invasive infections in the past 40 years?" She answers herself by explaining "According to Smith and Haynes (1972) a 399% increase in the incidence of invasive Hib infections was recorded from 1942-50 through 1951-59 to 1960-68. Similar trends were presented by Bjune et al (1991). The best demonstrable common factor in this period is a documented push for mass vaccination. This explanation is especially plausible since the number of cases has not increased in babies below three months of age since 1942! ….This clearly implicates DPT injections in the increase of Hib diseases."

Canada began to report Hib in 1979 but from 1979 to and including 1985 only cases of meningitis were reported. As the graph above shows, during this period there were only 220 to 420 cases of Hib meningitis per year in Canada. According to Health Canada, at this time about two-thirds of all Hib diseases occurred in children younger than 18 mos and over 80% occurred in children younger than 5 yrs. In 1986 two important changes occurred: all types of invasive Hib disease began to be reported and the first Hib vaccine was introduced. However, this vaccine was found to be ineffective in children younger than 18 mos. Considering the 55% increase from 420 cases in 1985 to 650 cases in 1988 and knowing that only 35-50% of all Hib cases do not develop meningitis and, of those, not all develop invasive disease, it seems likely that some of the increase was due to an "unprotected period", also referred to as a "negative phase" which occurs during the first week following Hib vaccination (see 'Risks' in the next section). In 1988 a second vaccine was introduced which, Health Canada now says "is currently not recommended in Canada because it induces antibody responses that are suboptimal". Two more Hib vaccines introduced in 1991 were licensed for use in infants 2 mos or older, as was the forth version introduced in 1992 (the one used in Pentacel). By 1994, Hib disease had declined to fewer than 100 cases per year, the highest incidence still in infants. ⁽¹³⁾

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Haemophilus influenzae type b vaccine (Hib)

Efficacy: The Hib portion of Pentacel has the unusual requirement of injection either at the same time as Quadracel but in a different location, or, in one location immediately after being combined with Quadracel. A 'Medscape' article explains that a combined Hib-Quadracel type vaccine has not been accepted in the USA due to an interference problem: "In 1997, the FDA rejected the application of Pasteur-Merieux-Connaught (Aventis Pasteur) 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." ⁽¹⁴⁾ Although the Pentacel monograph quotes antibody responses to the Hib portion of 81-98% after three doses, when it was combined with Quadracel to make Pentacel rather than injected separately, response to the tetanus portion was diminished. The monograph states; "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 Disease 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. ⁽¹⁵⁾ Public health's answer to the problem has been to introduce yet another provocateur of pathogens: PrevnarTM, a 7-valent (ie having 7 different bacterial strains) pneumococcus vaccine for children (see the enclosed article to learn about the many problems with this vaccine).

Not only that, but 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 Hi 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 Pentacel monograph states: "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. ⁽¹⁶⁾

One chronic 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 Pentacel must make it a main contributor to childhood diabetes. ⁽¹⁷⁾

Following many years of research, Rita Hoffman, 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 noted 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. For more on this, we encourage you to visit www.vran.org/vaccines/anaphylaxis/vaccine-ana.htm to see the amazing research Rita has done. She cites study after study which connects allergies and anaphylaxis to Hib vaccine as well as pertussis vaccine, aluminum adjuvants and multiple-antigen vaccines. She has 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." ⁽¹⁸⁾

The Pentacel monograph says the Hib portion of the vaccine should not be given during acute illness, including illness accompanied by a fever. Allergy to any component, including tetanus protein or an allergic or anaphylactic reaction to a previous dose constitutes a contraindication to Hib vaccine. In immunocompromised individuals, including those on corticosteroids, "the expected immune response may not be obtained." The monograph says Hib vaccine "may be of benefit in preventing the occurrence of secondary cases. However, epidemiological studies have not been done and rifampin or other appropriate prophylaxis is still recommended. Because the vaccine will not protect against non-typeable strains of H. influenzae which cause recurrent upper respiratory disease, otitis media and sinusitis, the vaccine is not recommended for these conditions." The manufacturer states that there may be some immune response to the tetanus portion of Hib vaccine but "Individuals who have received multiple doses of products containing tetanus toxiod show no difference in reaction rates when immunized with this vaccine." Since animal reproduction studies have not been conducted and it isn't known if Hib vaccine can cause harm to a foetus or can affect reproductive capacity, it is not recommended for use during pregnancy. As is usual with vaccines, Hib's potential as a carcinogen or mutagen has not been assessed.

The monograph admits the following adverse reactions: pain, redness, swelling or induration, in up to 30% of recipients, usually of moderate intensity; edema with cyanosis or purpura of the lower extremities, especially when administered with another vaccine (as in Pentacel) in rare cases; allergic reactions including urticaria, pruritus and swelling of the larynx in rare cases. Systemic reactions observed when Hib vaccine has been given together with DPT have been similar to those from DPT alone except that there is more fever when Hib vaccine has also been given.

Pentacel vaccine (DTaPIPVHib)

The manufacturer of the vaccine, Aventis Pasteur, states that vaccination with 'Pentacel' "should be deferred in the presence of any acute illness, including febrile illness to avoid superimposing adverse effects from the vaccine on the underlying illness or mistakenly attributing to the vaccine a manifestation of the underlying illness." You should also be cautious if your child has been sickly previously and consider avoiding or delaying the shot if he/she has been in close proximity to someone who currently has an infection. (For those who choose to vaccinate, we advise having a doctor take your child's temperature and thoroughly examine throat and ears to ensure there's no infection present. Giving your child extra vitamin C for a few days before and after the injection might also help.) The manufacturer warns that 'Pentacel' should not be used if your infant/child is allergic to any of its ingredients or has had an allergic or anaphylactic reaction to a previous dose. A family history of severe allergies such as excema and asthma also warrants caution. The manufacturer states: "Because simultaneous administration of common childhood vaccines is not known to affect the efficacy or safety of any of the routine recommended childhood vaccines, if return of a vaccine recipient for further immunization is doubtful, simultaneous injection of all vaccines appropriate for age and previous vaccination status (including MMR, other Haemophilus influenzae type b conjugate vaccines, hepatitis B vaccine) at separate sites with separate syringes is indicated." Of course the reason possible synergistic effects of administration of many vaccines at one visit is unknown is that studies on this have not been done and adverse events in the real world are seldom reported. This "jab 'em while you can" attitude completely ignores the Precautionary Principle. The vaccine ingredients include: 2-phenoxyethanol; aluminum phosphate; Tween 80; human albumin (from tissue of an aborted foetus used in the production of the polio vaccine); bovine (ie cow) serum. Trace amounts of formalin and the antibiotics, polymixin B and neomycin may be present. The reason why thimerosal is not used as the preservative is that it would render the polio vaccine impotent. Canadian clinical trials of QuadracelTM (Pentacel minus Haemophilus influenzae type b) showed "a trend towards increasing local reaction rates at the 4th and 5th doses". On the other hand, systemic reactions were more frequent in first doses at 2 mos: 51% had decreased activity; 45% were fussy; 34% decreased feeding; 30% cried; 21% had fever; 8% vomited and 8% had diarrhea.

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References:

1. The Vaccination Dilemma, 2002, edited by Christine Murphy: 'Common Childhood Illnesses' by M Gloecker, MD and W Goebel, MD; pgs 56-58. What Your Doctor May Not Tell You About Children's Vaccinations, 2001, by Stephanie Cave, MD, FAAFP; pgs 136-137. Mosby Medical Encyclopedia, 1996: Signet. The Informed Parent, June 2000: 'Whooping Cough: The Disease and the Vaccine' by Dr Jayne Donegan, MB, DRCOG, DCH, MRCGP (also at www.whale.to/w/donegan.html ).


2. Immunization: History, Ethics, Law and Health, 1999, by Catherine J M Diodati, MA.


3. 'Whooping Cough: The Disease and the Vaccine'.


4. Vranewsletter, Fall 2003: 'Message to Autism Conference' by Viera Scheibner, PhD. Here's Health, March, 1980: 'Danger' by professor Gordon Stewart (also at http://www.whale.to/vaccines/stewart.html ).


5. National Consensus Conference on Pertussis, April, 2003; Health Canada Canada Communicable Disease Report Vol 129 S3: presentation by Dr Mark Peppler.


6. 'Whooping Cough: The Disease and the Vaccine'.


7. 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.


8. Health Progress, 1935-1945, 1948, Metropolitan Life Insurance Co; pg12.


9. Vaccinations: A Thoughtful Parent's Guide, 2001, by Aviva Jill Romm; pgs 34, 76-77 and 227.


10. The Encyclopedia of Common Diseases, 1962, by J I Rodale, Editor-in-Chief, Rodale Books Inc; Section 53, 'Polio".


11. What Your Doctor May Not Tell You About Children's Vaccinations; pgs 152-155. Vaccinations: A Thoughtful Parent's Guide; pgs 81-82.
    Vaccine Preventable Diseases, Health Canada, English
    Maladies évitables par la vaccination, Agence De Sante´ Publique du Canada, French
    PPHB, Division of Immunization and Respiratory Diseases: 'Haemophilus influenzae type b'; http://www.phac-aspc.gc.ca/im/vpd-mev/hib_e.html English
    http://www.phac-aspc.gc.ca/im/vpd-mev/hib_f.html French


12. Vaccinations: A Thoughtful Parent's Guide; pgs 81-82. What Your Doctor May Not Tell You About Children's Vaccinations; pg 151.


13. Vaccine Preventable Diseases, Health Canada, PPHB, Division of Immunization and Respiratory Diseases: 'Haemophilus influenzae type b'.


14. 'Rocky Road to Combination Vaccine Licensure'; http://www.findarticles.com/p/articles/mi_m0BJI/is_7_30/ai_62050681#continue.
    Combo Vaccine Rules Too Strict - Brief Article http://www.findarticles.com/p/articles/mi_m0BJI/is_22_30/ai_67716881.


15. 'The Perilous Haemophilus, or is it …Pneumonia', July, 1996, by Hilary Butler for the Immunization Awareness Society; www.vran.org/vaccines/pneumococcal/pne-butler. Specific Vaccines; pneumococcal.


16. Immunization: History, Ethics, Law and Health; pgs 80-81.


17. VRANewsletter, July-Oct 2000, pg 27: 'CDC Supports Causal Relationship Between Vaccines and Diabetes'.


18. A small part of Rita Hoffman's research is included in VRANewsletter, Dec 01-Feb 02, pg 17: 'Multiple Vaccines and the Growing Epidemic of Life Threatening Anaphylaxis'.

Vaccination Risk Awareness Network Inc : March, 2004