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<\/a><\/p>\nBy Robert F. Kennedy, Jr.<\/p>\n
Vaccine scientists and the public health community cautiously and occasionally will admit that vaccines can cause adverse reactions just like \u201cany other medication or biological product<\/a>.\u201d Although experts are less willing to openly disclose the fact that adverse reactions can and do include death, one has only to look at reports to the U.S. Vaccine Adverse Event Reporting System (VAERS) to see that mortality is a possible outcome. From 1990 through 2010, for example, VAERS received 1,881 reports of infant deaths following vaccination, representing \u00a04.8% of the adverse events<\/a>reported for infants over the 20-year period. Moreover,\u00a0analysts<\/a>acknowledge that VAERS, as a passive surveillance system, is subject to substantial underreporting. A federal government\u00a0report<\/a>\u00a0from 2010 affirms that VAERS captures only about 1% of vaccine adverse reports.<\/p>\n On the international frontier, the public health community\u2014with the World Health Organization (WHO) in the vanguard\u2014previously used a\u00a0six-category framework<\/a>\u00a0to investigate and categorize serious adverse events following immunization (AEFI), including death. Guided by this tool, public health teams examined temporal criteria and possible alternative explanations to determine whether the relationship of an AEFI to vaccine administration was \u201cvery likely\/certain,\u201d \u201cprobable,\u201d \u201cpossible,\u201d \u201cunlikely,\u201d \u201cunrelated,\u201d or \u201cunclassifiable.\u201d<\/p>\n In\u00a02013<\/a>, the WHO\u2019s Global Advisory Committee on Vaccine Safety discarded the prior tool, ostensibly because users \u201csometimes [found it] difficult to differentiate between \u2018probable,\u2019 \u2018possible,\u2019 and \u2018unlikely\u2019 categories.\u201d The WHO enlisted vaccine experts to develop a \u201csimpler\u201d algorithm that would be more readily \u201capplicable\u201d to vaccines. The resulting\u00a0four-category system<\/a>now invites public health teams to classify an AEFI as either \u201cconsistent,\u201d \u201cinconsistent,\u201d or \u201cindeterminate\u201d with a vaccine-related causal association or as \u201cunclassifiable.\u201d Despite the patina of logic suggested by the use of an algorithm, \u201cthe final outcome of the case investigation\u00a0depends on the personal judgment of the assessor<\/em>\u201d [emphasis added], especially (according to the tool\u2019s proponents<\/a>) when the process \u201cyields answers that are both consistent and inconsistent with a causal association to immunization.\u201d<\/p>\n In a 2017\u00a0letter<\/a>\u00a0in the\u00a0Indian Journal of Medical Ethics<\/em>, Drs. Jacob Puliyel (an India-based pediatrician and member of India\u2019s National Technical Advisory Group on Immunization) and Anant Phadke (an executive member of the All India Drug Action Network) raise important questions about the revised tool. They describe an Orwellian Catch-22 situation wherein it is nearly impossible to categorize post-vaccine deaths as vaccine-related. This is because the revised algorithm does not allow users to classify an AEFI as \u201cconsistent with causal association with vaccine\u201d\u00a0unless<\/em>\u00a0there is evidence showing that the vaccine caused a statistically significant increase in deaths during Phase III clinical trials.\u00a0By definition<\/a>, however, any vaccine not found to \u201cretain safety\u201d in Phase III trials cannot proceed to Phase IV (licensure and post-marketing surveillance). The\u00a0result<\/a>\u00a0of the algorithm\u2019s convoluted requirements is that any deaths that occur post-licensure become \u201ccoincidental\u201d or \u201cunclassifiable.\u201d<\/p>\n Drs. Puliyel and Phadke\u00a0describe what happened in India<\/a>\u00a0when the country\u2019s National AEFI committee assessed 132 serious AEFI cases reported between 2012 and 2016, including\u00a054 infant deaths<\/a>\u00a0that followed administration of a pentavalent all-in-one vaccine intended to protect recipients against diphtheria, tetanus, pertussis, hepatitis B, and\u00a0Haemophilus influenzae<\/em>\u00a0type b infections. For babies who survived hospitalization, the committee classified three-fifths (47\/78) of the AEFI as causally related to vaccines (with 47% of the incidents viewed as \u201cproduct-related\u201d and 13% as \u201cerror-related\u201d), but they rated nearly all (52\/54) of the deaths as either coincidental (54%) or unclassifiable (43%) despite mounting\u00a0evidence<\/a>\u00a0that pentavalent and hexavalent vaccines are increasing the risk of sudden unexpected death in infants.<\/p>\n The absurdity and negligence inherent in the ultimately subjective WHO checklist have not escaped the attention of others in India and beyond. In a series of\u00a0comments<\/a>\u00a0published in the journal\u00a0Vaccine<\/em>\u00a0in response to the 2013 publication of the revised tool, commenters issued the following scathing remarks:<\/p>\n Unfortunately, many\u00a0vaccine proponents<\/a>\u00a0appear to be more concerned with forestalling \u201cmisconceptions\u201d and \u201cerroneous conclusions about cause and effect\u201d than they are about preventing and identifying adverse events following vaccination. The result,\u00a0as Dr. Puliyel argues<\/a>, is that doctors who \u201cna\u00efvely\u201d accept biased reports on vaccine safety \u201care losing the trust of the public and in the process\u2026endangering public health.\u201d<\/p>\n<\/p>\n\n