Vaccines - Associated Dangers - General Observations

Another basic issue that has never been raised in the programming, or evaluation contexts of Official Development Assistance supported mass immunization, is the requirement for effective monitoring and research on potential vaccinal adverse effects.

The issue of vaccine dangers and damage is obviously a rather unpleasant subject that no one really enjoys thinking or talking about. In fact it appears to have been totally ignored in both the planning and execution phases of Canada's International Immunization Programme(CIIP).

Furthermore, the recently completed Qperational Review of CIIP 1986--1991,which according to its sub-title was supposed to address inter alia ". . . lessons learned in the first three years, "failed to even raise the two very fundamental issues of vaccine effectiveness, and vaccine damage.120

In special PHC-EPI research conducted for the CIDA Evaluation Division, the conclusion was reached that the extensive literature written on the subject of immunization, adverse reactions and contra indications, points clearly to the reality that "massive immunization programs carry with them a number of very real risks and hazards.121

According to information recently provided by CIDA's Health and Population Directorate the World Health Organization as of October, 1990 has instituted a policy for "adverse event monitoring" in Developing World Immunization activities. A definitive policy statement on this issue titled Monitoring of Adverse Events Following Immunization, is apparently available as of April 1991. The implications of VMO's recognition of the significance of this issue to the setting of public policy priorities for EPI research, monitoring and evaluation should be apparent.

In order to provide some background on why the WHO is now taking these measures, a few critical observations follow. In recognition of potential vaccine dangers, David Karzon of the Vanderbilt University School of Medicine raises important policy considerations with respect to mass immunization programs in the Editorials section of the New England Journal of Medicine.

. . . there are two compelling reasons for reinspection of the process offormulating and implementing our immunization program: the emergence of new societal considerations and responsibilities; and the need for a fuller public disclosure of the costs of disease prevention . . . we as a society have not recognized and accepted all the costs . . . costs measured not only in dollars spent or saved, but also as adverse biologic reactions.

 

Literally no drug or procedure used in medicine is risk free. Immunizing antigens, originating from complex biological materials or arising as genetically attenuated live agents, have their own peculiar endogenous hazards, Complications . . . are particularly apt to be visible in mass immunization campaigns. . . . The quality of the data base for national decisions is critical because any vaccine recommendation carries such a vast Potentialfor harm or good.122

 

 

It is unfortunate that UNICEF EPI field reports tend to dismiss the concerns raised by "targeted" locals to the issue of vaccine damage, as based on misinformation provided by unreliable local health staff, or the ignorance of fearful mothers, both of whom need re-education.

For instance a recent UNICEF annual project report in discussing EPI stated, "A WHO-UNICEF team found that drop out rates were high because of the fear of side effects as expressed by mothers, (and) misinformation about contraindications . . . as communicated by health workers. . . . As a result, increased attention is being directed toward health education. . . ."123

To say the least, it seems incongruous that this issue is paternalistically ignored as an insignificant concern raised by the misinformed and the ignorant, when Canadian citizens are being alerted by the media that the Canadian Government is expected to announce "disaster relief" to families "of vaccine damaged children."124 This relatively recent report suggests that vaccine damage is likely more pervasive a problem than is generally acknowledged or believed.

In fact, it appears that chronic under-reporting of vaccine-induced morbidity, disability, and mortality appears to be the norm. Probably the most erudite scholar who has thoroughly investigated the issue of vaccine hazards, is Sir Graham Wilson. As Honorary Lecturer in the Department of Bacteriology at the London School of Hygiene and Tropical Medicine, the following observations are excerpted from an earlier lecture series delivered at that school.

The risks attendant in use of vaccines and sera are not as well recognized as they should be. Indeed our knowledge of them is still too small, and the incomplete knowledge we have is not widely disseminated.. a very small proportion [of the actual numbers of vaccine accidents] . . . have been described in the medical literature of the world.

 

 

. . . a large number of accidents--I suspect the majority--have never been reported in print, either through fear of compensation claims, or of giving a weapon to antivaccinationists . . . I have come to the conclusion that no vaccine or antiserum can be regarded as completely safe . . . no vaccine or antiserum that has yet been used has been free from complications or accidents . . . [with respect to assessing the "degree of possible danger" he indicates that] Unless both the numerator and the denominator are known, quantitative assessments may fall wide of the true mark. Moreover, the risk, even for a single vaccine, is not uniform. It varies, among other things, with the immunological status of the population concerned..

 

 

The inherent danger of all vaccination procedures should be a deterrent to their unnecessary or unjustifiable use. Vaccination is far too often employed, especially in the developing countries . . . and should not be used as an [instead] excuse from applying the well tried standard methods for the prevention of infectious disease. Most important is it to realize the potential dangers of mass immunization. In such an operation time does not permit an inquiry into the suitability of each individual subject for vaccination.125

 

 

A strong echo of Wilson's conclusion that vaccine damage is chronically under reported, is found in the official minutes of the 15th session of the US Panel of Review of Bacterial Vaccines and Toxoids with Standards and Potency:

Many physicians are not cognizant of the importance of reporting untoward reactions, or may be unaware of their clinical features. Further, both physicians and manufacturers have been held liable for damage suits by patients who may suffer adverse effects from established vaccines. All of these factors undoubtedly discourage reporting; without some other form of surveillance, definition of the rates and significance of untoward reactions to current and future vaccines cannot be ascertained.126

 

 

H.S. Martland, former Chief Medical Examiner for Essex County New York, describes how the above unawareness actually translates into practice:

Deaths from brain and spinal cord diseases (poliomyelitis, encephalitis, and meningitis) resulting from . . . immunizations sometimes are attributed to other causes, because doctors are not sufficiently alerted to the connection between immunizations and the deaths. . . .127

 

 

Neustadter maintains that the research on vaccine side effects by the pharmaceutical industry remains seriously marginalized due to a significant number of vaccine reactions going unreported, and the fact that it is often difficult to attribute delayed effects with a vaccine. He further suggests that the reason that the medico-pharmaceutical industry has consistently failed to address the unanswered question of the long term effects of vaccines, stems largely from their overriding interest in the active promotion, and rapid marketing of vaccines.

Investigation of their adverse side effects generally remains a non-priority issue, insofar as such efforts may undermine the public's acceptance of their products.128 On the other hand, Snead suggests that when laboratories go public to the media and confirm that "no known problems" exist, this does not mean that scientists have researched to the limits of their knowledge and found no side effects, but rather that no research has actually been done.129

Although there is compelling evidence that vaccine induced damage remains chronically under-reported, it is of interest that B. Bloom of the Albert Einstein College of Medicine, openly admits that there is today an emerging reluctance on the part of medico-pharrnaceutical industry to further develop vaccines, for both the developed and Developing Worlds.

According to Bloom, this reluctance stems from the fact that financial losses due to the "liability" of established vaccines, actually exceed the "profits" derived from them.130 

In this vein, Mendelsohn indicates that vaccine costs have "skyrocketed" as a consequence of multiple jury awards to damaged children. In his words:

As more and more parents begin to recognize the link between vaccines and their child's condition--epilepsy, convulsions, mental retardation, cerebral palsy, Sudden Infant Death, etc.--lawsuits have become commonplace. As drug companies exit the vaccine field, public health authorities worry about vaccine shortages. 131