Although the Assessment did not go on to define the nature of the controversies surrounding immunization, mass immunization programs have been seriously questioned on both developmental and scientific grounds.

It will be the purpose of this report to proceed with a detailed examination of the issues of controversy, draw some conclusions, and make appropriate recommendations. The critique of these issues stems from a careful review and evaluation of wide ranging biomedical literature sources of relevance to the subject. This work has been carried out in the spirit of honest inquiry, thus affording a fresh and critical analyses of the fundamental issues.

Although the conclusions as reached visibly sustain "one side" of what is largely a hidden and professionalist dominated debate on immunization, the reader should note that this is done in order to provide a long neglected and constructive counterbalance to the predominating supportive declarations of the establishment, and in turn the parroted promotion of the same view by the popular media.

UZNICEF'S GENERAL EPI STRATEGY AND STATED ACHIEVEMENTS

In a UNICEF sponsored research study on immunization coverage conducted in Thailand in the mid 80's, the following general observation is made:

[The] immunization programme has been proven to be an efficient, and relatively inexpensive method of disease prevention in both developing and developed countries. In the last decade, we have seen an increase in immunization usage, public acceptance, improved delivery techniques and more stable vaccines. The more extensive use of vaccines has resulted in a dramatic decrease of many leading communicable diseases in all parts of the world. However, this condition is by no means true in developing countries where most of the vaccine preventable diseases like diphtheria, pertussis, neonatal tetanus, poliomyelitis and measles remain to be a serious health menace among infants and children in these countries."13

The view as expressed here--during the early stages of this project--provides a fair representation of the rationale behind UNICEF'S resolve to proceed with its universal disease eradication drive, via vaccine induced immunization. 

FIELD OBSERVATIONS

On the basis of structured and semi-structured interviews in five provinces, five districts, and nine villages visited, the following facts came to light:

• The EPI component objectives were comprehensively and successfully implemented, exceeding the original numerical targets
  
  
• EPI was reported as the "only activity that is implemented and recorded entirely by government (health) officials"
  
  
• All parents had been informed that: immunization was an effective, and essential life-guarding measure, and although it could result in fever or a minor rash for their infants, this should be expected as normal (a small price to pay for the benefits received); and that otherwise the procedure was very safe and should pose no cause for fear or alarm
  
  
• The most commonly reported side effect of infant vaccinations was fever, with village reports ranging from a low of 6% of infants immunized to "99%." (Rashes were the second most commonly reported side effect)
  
  
• Fever reducing drugs are either routinely administered to vaccinated infants, or administered on request of parents (however, one village did report the effective use of water instead of drugs to reduce fever), and
  
  
• Sisaket province reported that "rare" cases of post-vaccination shock have occurred, attributing this to vaccinal "overdose." Surin province reported that there were cases of post-vaccination shock in various other provinces, but not in Surin. Such cases were attributed to the vaccine vial not being "sufficiently shaken."

CONTRA-INDICATIONS SCREENING

Evidence indicated that the EPI program did not incorporate adequate measures for contraindications pre-screening and post-monitoring.

1. All infants received the vaccines regardless of their weight or nutritional status (only one village indicated that vaccines were not given to infants severely underweight, and only one province reported post-vaccination monitoring of infants under 3 kg).
2. Actual nutritional status assessment does not appear to be conducted on infants (excepting the body weight factor) before administering vaccination.
3. There did not appear to be any procedural requirements for checking family histories to determine whether there existed any history of neurological disorders before administering vaccination.

A CASE HISTORY

Upon completing the briefing session with a large contingent of Surin provincial and Northeast regional health officials--at which the chief provincial spokesperson confirmed that although post-vaccination shock was a problem in other provinces, there were no known cases being reported in his province evaluation team members departed for their respective village destinations. Upon entering the village of Kanjarong, in the Chom Phra district (only 35 miles distant from the provincial capital) in company with the UNICEF Integrated Services Project Monitor, we encountered and met with the village Head Man and the Deputy Head Man.

In the course of the interview, the Deputy Head Man, with some intensity explained that his own son had experienced what he considered as very serious damage as a result of immunization. The Project Monitor and I returned the following day, at which time we both interviewed the mother and observed the affected child during the interview. As a result of this more careful and thorough interview, the following facts of the case were ascertained:

• Up to the age of 3 months the infant had been breastfed. Breastfeeding was terminated by the mother due to a diagnosed thyroid deficiency, per the "doctor's" request. She subsequently began feeding him powdered milk, supplemented by egg, meat, and white rice. The use of fresh fruit and vegetables in the infants diet remained very marginal.
  
  
• At the age of 8 months the infant was taken in for his final DPT (triple antigen) vaccine. He almost immediately went into what was diagnosed and described as a state of "shock," for which he was duly treated by a physician. As well, a whole series of serious problems began:
  1. chronic sleeplessness
  2. high fever
  3. unbroken colds and runny nose continuing over several months
  4. unbroken crying (except when held) for a period exceeding 2 months
  5. in the eleven months following the vaccine (the child at time of inter-view was I year 7 months) there appeared to be severely impaired weight and growth developments.

     Although cognizant that this case history could be construed (and in turn dismissed) as a rare anecdotal occurrence that was only coincidental to the administration of the triple antigen vaccine, after careful thought I've decided to included it in some detail for three basic reasons:

     I. evidence suggest that for multiple reasons--as noted throughout this document--such adverse reactions are likely to be taking place at a significantly greater level than is popularly believed;

     II. a calm, intelligent and caring mother's direct experiential observations and hindsight about her child represent a fully valid and trustworthy source of information; and

     III. overall, the clarity and force of the evidence was such that the child's reaction was clearly more than a mere coincidence, and thus not attributable to other direct causes. (As well there is clear evidence suggesting that the occurrence and severity of adverse reactions to vaccines--among infants--correlate proportionally to both lack of breasffeeding, and Vitamin C deficiency (e.g., see refs. 17 & 18).

The following comments should be made with respect to points (a)-(e) above:

• The evidence of unabated infections suggests general impairment of the child's immune system, i.e., vaccine induced immune malfunction.
• The unbroken crying (its unfortunate that children under the age of one can't verbally explain the nature and extent of their distress) suggest the possibility of permanent nervous system damage. (In observing the child walk about, it was visibly evident that his general motor functions and coordination were impaired.)

The reported growth stunting effect was also visibly obvious, as the child appeared to be at most the size of a one year old. (In that impaired growth is generally not identified in the literature as a vaccine related or induced hazard, this condition may well have been principally related to other factors bearing on the child's nutritional intake and or assimilative capacities.) The mother reported that his weight at birth was 4 kilos (a very heavy baby by Thai standards) and at 5 months, 9 kilos. At the time we visited--though now I year and 2 months older--his weight was unchanged, still at 9 kilos.

It is also worth noting that the mothers three month old grandson, who was present during the interview, had been experiencing high fever, and continuous colds since having received recent inoculations. Given that I visited only 9 out of over 900 participating villages, and then only raised this issue with a fraction of respondents, poses serious concern as to just how widespread and serious the problem of adverse side effects is.

It is known for instance that when mass immunization programs were enforced in Australia's Northern Territory among what was a generally malnourished Aboriginal population (the most notable concern being Vitamin C deficiency) death rates doubled, in some areas approaching 50 percent i.e., "Every Second Child." According to the author of a book by that title and veteran physician to the Aboriginals A.Kalokerinos:

A health team would sweep into an area, line up all the Aboriginal babies and infants and immunize them. There would be no examination no taking of case histories, no checking on dietary deficiencies. Most infants would have colds. No wonder they died Some would die within hours . . . Others would suffer immunological insults and die later from pneumonia, 'gastroenteritis'or 'malnutrition'.19

In Northeastern Thailand, in the villages visited practically all mothers were breastfeeding, and were to some extent including fresh garden vegetables and fruit in their diets. This in turn provided a fair degree of protection from the kind of severe reactions and mortality just noted among Australian Aboriginals. Nonetheless, it is apparent that there still remains a sizable number of malnourished. To quote C. Guthrie:

Malnutrition seems to be declining in the Northeast... Still, malnutrition is widely prevalent. One does not need to go looking for it. In one school . . . in Don Luang, 50 percent of the children were suffering from one level of malnutrition or another. I found it somewhat disturbing to find that the objective expressed by most officials was restricted to the eradication of 3rd degree malnutrition, in spite of the wide prevalence of 1st and 2nd degree malnutrition.20

It appears that the mass coverage obsession common to UCI and EPI, have run roughshod over the repeated qualifications, and warnings that have been issued against administering vaccines to inimunodeficient infants and children, of which malnutrition is a prime indicator. The fact that a March 1988 Annual Report on this Project (p. 5) indicated that a WHO/UNICEF review team found that EPI "drop out rates were high, because of the fear of side effects as expressed by mothers," suggests that the prevalence of vaccine induced complications and morbidity in Northeast Thailand, may well be more significant than heretofore thought. (The broader question and implications of vaccine induced morbidity and mortality will be examined in more detail, later in the report.)

VACCINE SCHEDULING

The rationale behind administering multiple vaccines and toxoids throughout the first 14 week period of an infant's life (excepting measles) is that in the first year of life--when the immune system is still relatively immature--a child is considered more susceptible to most infectious diseases. However, this view fails to admit the corollary that the immune and nervous systems of infants, are immature thus making them potentially more vulnerable to the toxic effects of vaccines and toxoids.

It is instructive to consider the experience of Japan in this regard. Delay of DPT immunization until 2 years of age in Japan has resulted in a dramatic decline in adverse side effects. In the period of 1970-1974, when DPT vaccination was begun at 3 to 5 months of age, the Japanese national compensation system paid out claims for 57 permanent severe damage vaccine cases, and 37 deaths. During the ensuing six year period 1975-1980, when DPT injections were delayed to 24 months of age, severe reactions from the vaccine were reduced to a total of eight with three deaths. This represents an 85 to 90 percent reduction in severe cases of damage and death. 21

Although it is obvious that conditions in Japan remain distinctive from that of most Developing World countries, it must be noted that insofar as susceptibility to infectious disease remains greater in lesser developed countries, it clearly follows that susceptibility to vaccine damage will also be proportionally greater. Thus the lesson from Japan carries a valid message relative to the prevention of vaccine damage in Developing World EPI campaigns.

IMMUNIZATION'S IMPACT IN THE DECLENSION OF INFECTIOUS DISEASES

Statistics indicate that over the life of this project, Thailand (and presumably the Northeast region, for which direct figures were not available) has exhibited some degree of declension in childhood infectious diseases (excepting measles) for which immunization has--in recent years--been made generally available. However, it must be borne in mind that prima facie improvement in morbidity levels--in end of itself--falls far short of proving any actual interventional cause and effect relationship for EPI.

Direct discussions with the International Development Research Centre's Health Sciences Division confirms that in selective primary health care activities, such as EPI, there exists "no good base line data from which to measure health care outcomes. SPHC (Selective Primary Health Care) programs in the implementation of EPI appear to ignore this whole issue," Due to the strong and widely maintained assumption that interventions such as EPI serve inextricably and directly as the basis for health improvement outcomes, there has been a general failure since the inception of the first vaccine programs to establish genuinely verifiable evidence for their long term effectiveness, and safety. 22

The general nature of this problem in Selective Primary Health Care activities is well expressed by prominent Medical Sociologist J. Williamson, when he says there has been a failure to "assess explicitly the degree of validity and sufficiency of the evidence linking care structures (facilities, personnel), and processes (what providers do, e.g., EPI) to outcomes of care in general and to health outcomes in particular."23

Epidemiological science is largely predicated on the reality that changes in morbidity and mortality in populations are necessarily linked to a whole series of contributive factors." (Noted authority George Dick states that: "Many infectious diseases can be prevented without immunization, because once the natural history of the disease is understood, the source may be eliminated or transmission prevented [e.g.,] . . . . When it was discovered that cholera and typhoid epidemics were regularly transmitted by faecal contamination of water, the provision of clean water supplies nearly eradicated these diseases from many countries without recourse to immunization.")24 It is widely acknowledged that factors such as: nutrition, sanitation, potable water; the natural and social environments (e.g., agricultural practices, food supply, education and income), all play vital roles in determining the onset, severity, and eradication of both infectious and degenerative diseases. Diseases such as cholera and typhoid, have been strongly linked to water and sanitation, whereas evidence continues to accumulate that nutrition remains likely the most critical determinant factor in the full range of infectious and degenerative human diseases.25

The very fact that in this UNICEF project--as in many others--EPI is implemented over a period of years in the midst of a whole series of other natural and basal socioeconomic improvement measures, each having their own critical impact on any population's health status (including epidemicity levels) suggests that EPI could actually be playing a negligible or even a negative role, and no one would really know the difference.

According to the recently completed comprehensive Program Evaluation of the Canadian International Immunization Program--Phase 1, this poses a situation in which the relative impact of expanded immunization programs on mortality levels in the Developing World remain largely unsubstantiated. To quote: "at present it appears that there is no conclusive evidence on the impact of immunization on child mortality from all causes . . . It may be that EPI's effect is merely to bring about "replacement mortality," whereby children . . . succumb to other diseases instead. The uncertainty over the impacts of EPI remain a major question in PHC programming."26

In a similar vein, Debabar Banerji, Chairman of the Centre of Social Medicine and Community Health at Jawaharlal Nehru University raises serious concerns with the UNICEF sponsored Universal Childhood Immunization program in his own nation. He suggests that:

If we turn to the epidemiological analysis of UCI-90 in India, we are astonished to learn that such a gigantic program has been launched without having even the most basic data on infectious diseases . . . Then how will it be possible to determine the cost-effectiveness of the program? Actually, there ought to have been much more detailed analysis. . . . 

For example, with regard to disease levels and factors, he urges that very basic questions should have been addressed before implementing UCI, such as: . . . how different are the rates in different parts of the country and what are the ecological, cultural, social and other factors which affect the rates--through influencing the balance between the host, the parasite [i.e., virus or microbe] and the environment. Information should have been provided on what are the trends in the epidemiological behaviour of the different diseases over a time period, what should be the epidemiological strategy for intervention in the natural histories of the diseases, and so on. Paying scant attention to such critical epidemiological considerations, the crusaders of UCI-90 have opted in favor of saturation spraying with "silver bullets " [vaccines]. Over and above this, there are also the important questions of efficacy of the vaccines. . .

Administratively, the exponents of UCI-90 seem to indulge in collective amnesia to wish the bitter experiences of major vertical [top down] programs like the mass BCG Campaign, the National Malaria Eradication Program, and the three [national] efforts at eradication of smallpox . . . Also actively shunned are the many lessons from the failures of vertical programs for trachoma, leprosy, filariasis, cholera, and sexually transmitted diseases." 27

 

INCOMPLETE STATISTICAL REPORTING

Selectively slanted and incomplete reporting of the true statistical picture is not an infrequent problem in the promotive oriented reporting on EPI impact data. For example, the following Tables B and C, were based on data presented in Section 4.3 "Expanded Programme of Immunization," in UNICEF's Fourth Progress Report CUC/CIDA Development of Basic Services for Children in Thailand, covering the period January--December, 1988.

The following comment is made with respect to the expansion of the measles vaccination program, ". . . the immunization coverage for measles has increased from 6 percent in 1984 to 63 percent in 1988, leading to a reduction in measles prevalence from 93.7/100,000 in 1984 to 37.1/100,000 in 1986."

What the report fails to indicate though is that although the 1986 inununization coverage of 44% had increased
by 1987 to 60%, the measles infection rate in the same period actually MORE THEN DOUBLED,
with an increase from 37.1 to 87.1 per 100,000.

It is also noteworthy that the culminating maximum immunization coverage of 63% achieved in 1988, correlates with a 1988 infection report rate of 59.1 /100,000--which in fact poses higher level of measles infection than the 1982 reported infection rate of 57.1 /100,000, which was a time when measles immunization was not being provided in Thailand.

(The higher per capita infection rate--after five years of expanding coverage--obviously reflects very negatively on the assumed efficacy of the vaccine, and may have been deliberately obfuscated in the reporting. No evidence was seen to suggest that the post-immunization increases in disease rates were attributable to case reporting improvements.)

THE DEVELOPMENTAL IMPLICATIONS OF UCI/EPI

In his own words, the Universal Childhood Immunization initiative, constitutes the efforts of ruling interests in Donor nations:

. . . to hit out at the very core of the philosophy of primary health care by imposing technocentric vertical programs against a few diseases in the name of saving children . . .This movement not only tends to fragment a health care system and take it away from a wider ecological, intersectoral, and integrated approach, but it also actively hinders community self-reliance and seriously erodes the democratic rights of the people to participate in decisions which so vitally concern them. This is perhaps the most malignant facet of the present efforts to impose specialized . . . programs from outside, using social marketing techniques to sell them." 29

 

Researchers like Rifkin and Walt maintain that interventions such as EPI, are essentially based on the (now fading) view that human health is dependent upon and arises from a force of elite professionals who hold privileged knowledge--coupled with corresponding power and control--to effect their disbursal of technocentrically contrived benefits, to relatively ignorant and passive recipients.30 It goes without saying that any programmed encouragement of this mind set--despite the very best of intentions--constitutes an inimical force to those principles and processes whereby intelligent self-development, and informed self-care can prevail.

In reference to the developmental implications of UCI/EPI, medical sociologist L.J. Chetelat notes that:

Health professionals, by taking and promoting easily executed interventions, such as immunization, create a demand for these programs and raise expectations which are seldom realized.. SPHC by identifying specific techniques (such as EPI) and strongly supporting them, diverts attention and resources from the process of development, to highlighting specific programs with exaggerated and often unpredictable outcomes. In reality, technocratic and "instant" successes, put into danger the long slow process that leads to sustained improvements. They are creating a climate of short-term expediency, rather than long term change.31