sponsored by VACCINATIONNEWS.COM and REDFLAGSDAILY.COM
A NOT-SO-PERFECT VACCINE: THE DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE: AN INVESTIGATION
By Red Flags Columnist, F. Edward Yazbak, MD, FAAP.
TL Autism Research
Falmouth, Massachusetts
E-mail: tlautstudy@aol.com
The Disease
Pertussis or Whooping Cough is an acute infectious disease caused by Bordetella pertussis. The disease has been described for centuries; the organism was first isolated in 1906. Whooping cough is transmitted through the respiratory route usually by droplets of secretions.
The incubation period is usually 7 to 14 days but may be as short as 5 days and as long as 21 days. The disease evolves in three phases. Patients are most contagious during the initial catarrhal stage consisting usually of minor cold symptoms and a slight nocturnal cough. During the paroxysmal stage, which may last for several weeks, the patient has the more characteristic coughing spells, which culminate in an inspiratory whoop and are often followed by vomiting. There is usually a marked leucocytosis (increased white count) and lymphocytosis (increased lymphocyte count). In newborns and young infants, whooping cough may present as apnea and cyanotic spells. During the convalescent stage, the paroxysms subside; the patient coughs less and clinical improvement becomes evident.
Erythromycin is the antibiotic of choice for the treatment of whooping cough. If given early, it shortens the course of the illness and reduces its severity. Because it also eradicates the organism from the secretions, it decreases spread and communicability.
Erythromycin or trimeththoprim-sulfamethoxazole prophylaxis is of value for close contacts and is recommended regardless of vaccination status.
According to the Centers for Disease Control and Prevention (CDC) “Since widespread use of the vaccine, incidence (of whooping cough) has decreased more than 98%, to an average of about 3700 cases per year since 1980... Whole-cell pertussis vaccine is composed of the suspension of formalin–inactivated B. pertussis cells. It was developed in the 1930s, and used widely in clinical practice by the mid 1940s”.
Until lately, the whole cell pertussis vaccine was available in combination with diphtheria and tetanus toxoids as DTP and contained thimerosal, a mercury derivative. The vaccine was also sometimes referred to as DPT. Both DTP and DPT refer here to the same product: Diphtheria and Tetanus toxoids plus whole-cell Pertussis vaccine.
The following statements are basic to whooping cough and whooping cough vaccination:
- The incidence of whooping cough in the United States had decreased before the introduction of the pertussis vaccine
- It has continued to decrease since the vaccine has been in use.
- Whooping cough may be a serious and potentially fatal illness in young and vulnerable infants.
- DTP vaccination has been associated with many severe and permanent adverse events including encephalopathy, brain damage, seizures, and even death. The reactions have been attributed to the pertussis component.
An excellent resource on the subject of DTP vaccine reactions is the website of the National Vaccine Information Center (1).
Of 253 infant deaths cases awarded more than 61 million dollars by the US Court of Federal Claims in the 1990s, 224, or 86%, were attributed to vaccination with DTP. The cause of death had originally been listed as Sudden Infant Death Syndrome (SIDS) in 90 of these cases or 40%. It should be noted that relatively few vaccine injury cases are ever filed in the United States and that, in only a small percentage of those cases, are the plaintiffs compensated.
There were sporadic reports of serious neurological complications and death following DTP vaccination in the fifties and sixties
In 1977, G. T. Stewart (United Kingdom) published an important study in the Lancet titled “Vaccination against whooping-cough. Efficacy versus risks”(2).
“Calculations based on the mortality of whooping cough before 1957 predict accurately the subsequent decline and the present low mortality. Notifications of incidence, though variable and incomplete, follow the same pattern of steady decline in the United Kingdom and are unaffected either by small-scale vaccination beginning about 1948 or by nationwide vaccination beginning in 1957… attack-rates may be lower and complications fewer in vaccinated children… No protection by vaccination is demonstrable in infants…Adverse reactions and neurotoxicity following vaccinations were studied in 160 cases. In 79, the relationship to pertussis vaccine was strong. In 14 of these cases, reaction was transient but characteristic of a syndrome of shock and cerebral disturbance, which, in the other 65 cases, was followed by convulsions, hyperkinesis, and severe mental defect. It seems likely that most adverse reactions are unreported and that many are overlooked. Precise information about the efficacy and safety of this vaccine is lacking, because existing provisions, national and international, for epidemiological surveillance and evaluation are inadequate. The claim by official bodies that the risks of whooping-cough exceed those of vaccination is questionable, at least in the U.K.”
In 1979, Stewart reported in the Scottish Medical Journal (3):
“Herd infections, especially in children, are strongly influenced epidemiologically by social and demographic factors which have contributed favorably to a general decline in incidence and mortality during the past 50 years or more. Intervention procedures such as immunization cannot be evaluated or planned realistically except against these background factors. Assessed in this way, immunization against diphtheria and poliomyelitis was unequivocally effective in reducing incidence and morbidity of these diseases. By comparison, pertussis vaccine has a very limited protective effect, the value of which, as morbidity decreases, may be offset by the intrinsic toxicity of the vaccine and by the possibility of infrequent but severe brain damage in some children. “
In 1982, William C. Torch, MD, Director of Child Neurology, University of Nevada School of Medicine presented a study at the 34th American Academy of Pediatrics (AAP) Meeting and stated: “These data show that DPT vaccination may be a generally unrecognized major cause of sudden infant and early childhood deaths, and that the risks of immunization may outweigh its potential benefits. A need for a reevaluation and possible modification of current vaccination procedures is indicated by this study." The Torch study findings were criticized as anecdotal.
In 1983, Baraff et al. reported a DTP-Sudden Infant Death Syndrome (SIDS) temporal association in the Journal of Pediatric Infectious Diseases. They reviewed cases of SIDS recorded in Los Angeles County and interviewed 145 families. The authors reported that there was a statistically significant excess of deaths in the first day and first week after DTP, a “temporal association”. The authors rejected the need to use a “Control Group” relying on the assumption that “there should be no temporal association between DTP immunization and SIDS, were there no causal relationship between these two events.”
In 1985, Professor G. T Stewart published another review article (4) titled “Whooping cough and pertussis vaccine: a comparison of risks and benefits in Britain during the period 1968-83”, in which he stated:
“Deaths of infants with whooping cough have decreased steadily since 1900 [i.e. before the isolation of the causative bacteria and the development of the vaccine] , the rate since 1975 being the lowest ever. Active epidemiological surveillance in Glasgow, with a population of 216,000 children and 13,000 births annually, shows that outbreaks and severe cases requiring admission to hospital were concentrated consistently in a few areas of deprivation… There were no deaths attributable to proven or suspected infections with Bordetella pertussis during the period 1972-1983. No cases of encephalopathy, permanent brain damage or lung damage were detected in a follow up of all cases notified, surveyed or admitted to hospital between 1975 and 1982. Collectively, these national and local data provided estimates of the frequency of infection, complications of infection, admission to hospital and death in children with whooping cough for comparison with local, national and published estimates of the frequency and severity of adverse reactions, encephalopathy, permanent brain damage and death after injections of pertussis vaccine. It is concluded that, in children living in non-deprived circumstances in Britain, the risk of pertussis vaccine during the period 1970-83 exceeded those of whooping cough. In some deprived sectors, the risks from whooping cough might have been marginally higher but there was no evidence that this was associated with any increase in deaths or permanent disabilities.”
A multidisciplinary workshop on the Neurologic Complications of Pertussis and Pertussis Vaccination was held in the fall of 1989 in Warrenton Virginia. Professors J. H. Menkes and M. Kinsbourne, both renowned neurologists and accepted experts in the field, published the report of that workshop which can be found in its entirety on the National Vaccine Information Center (NVIC) web site. To this day, the report remains the most careful and unbiased reference on the subject and the following information is gratefully reproduced.
About the disease: “ Pertussis mortality in the US is 2-3/1000 cases. Seizures occur in 1.9% of cases, and encephalopathy in 0.3%. It appears likely that a combination of one or more bacterial toxins, asphyxia, CO2 retention and loss of cerebral vascular autoregulation is responsible for the neurologic symptoms. The timing of the encephalopathy, suggests that it results from increased lysis of bacteria and release of endotoxin. The encephalopathy is not confined to the paroxysmal phase.
About the DTP vaccines: In evaluating side reactions to the vaccine, the following must be kept in mind:
- Vaccines are not standardized between manufacturers
- For a given manufacture, vaccines are not standardized from one batch to another.
- Unless the vaccine is properly prepared and refrigerated, its potency and reactivity vary with shelf life.
In fact, the whole question of vaccine detoxification has never been systematically investigated.
Listed in order of increasing severity, observed adverse reactions include irritability, persistent, unusually high pitch crying, somnolence, seizures, a shock-like “hypotensive, hyporesponsive” state, and encephalopathy. Since the neurologic picture is not specific for pertussis vaccination, its temporal relationship to the vaccination is that critical variable for determining causation.
Menckes and Kinsbourne went on to say that although the majority of seizures following pertussis vaccination were associated with fever, it was the consensus of the neurologists attending the workshop, that they did not represent febrile convulsions but that they were in fact non-benign convulsions.
The incidence of post-vaccine encephalopathy was difficult to ascertain. Quoting a British study by Miller published in the British Medical Journal in 1981, Menkes and Knsbourne stated: “…The relative risk of a previously normal infant for the onset of an illness leading to permanent encephalopathy was 4.2 times greater during the first 72 hours following DPT vaccination than in controls. From this study, the risk of permanent brain damage following DPT has been calculated as 1:310,000 doses….”
(Please note that the authors referred to “doses”. If each child actually received the recommended primary series (3 doses) and boosters (2 doses), then potentially, permanent brain damage from the DTP vaccine could be as frequent as 1:60,000 children)
It was the consensus of the workshop, and in particular, the participating neurologists, that although the vaccine may possibly accelerate neurologic signs or symptoms in some children, and a small proportion of apparent complications may be coincidental, there was no inherent difficulty in assigning cause and effect to the vaccine and subsequent neurologic residua…. In summary, it was the consensus that there is sufficient experimental data to implicate both endotoxin and PT (Pertussis Toxin) in adverse neurologic reactions to pertussis vaccine.”
Menkes & Kinsborne also reviewed the findings in 20 cases of seizures and encephalopathy following DTP vaccination seen by Prof. Jean Aicardi (Hopital des Enfants Malades, Paris). In all cases symptoms started within 72 hours, and usually within 24 hours of pertussis vaccination. Fifteen of the 20 patients developed symptoms within 12 hours of the vaccination. There was frequently change in consciousness or coma of several days duration, followed by an abrupt developmental arrest. Seizures presented as myoclonic epilepsy or status epilepticus. The EEG was originally normal in 75% of the cases but seriously deteriorated with time. The examination of the cerebrospinal fluid usually revealed normal findings.
