In a 2017 letter in the Indian Journal of Medical Ethics, Drs. Jacob Puliyel (an India-based pediatrician and member of India’s 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 “consistent with causal association with vaccine” unless there is evidence showing that the vaccine caused a statistically significant increase in deaths during Phase III clinical trials. By definition, however, any vaccine not found to “retain safety” in Phase III trials cannot proceed to Phase IV (licensure and post-marketing surveillance). The result of the algorithm’s convoluted requirements is that any deaths that occur post-licensure become “coincidental” or “unclassifiable.”
Drs. Puliyel and Phadke describe what happened in India when the country’s National AEFI committee assessed 132 serious AEFI cases reported between 2012 and 2016, including 54 infant deaths that followed administration of a pentavalent all-in-one vaccine intended to protect recipients against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type 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 “product-related” and 13% as “error-related”), but they rated nearly all (52/54) of the deaths as either coincidental (54%) or unclassifiable (43%) despite mounting evidence that pentavalent and hexavalent vaccines are increasing the risk of sudden unexpected death in infants.
…doctors who “naïvely” accept biased reports on vaccine safety “are losing the trust of the public and in the process…endangering public health.”
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 comments published in the journal Vaccine in response to the 2013 publication of the revised tool, commenters issued the following scathing remarks:
- “Even if a healthy child dies within minutes following vaccination and there is no alternate explanation for the AEFI, even then the powers that be could easily declare that death as coincidental and not due to the vaccine, thanks to the new AEFI. This is dangerous ‘science’.”
- “Amongst the 20 items of their checklist, no less than 15 (75%) are devoted to refute a vaccine-induced causality [emphasis in original]…. After all and as the authors confess with an astonishing ingenuousness, the main point is to ‘maintain public confidence in immunization programs.’”
- “People understand that there are no true coincidences—only events that have been made to appear to be coincidental by either a genuine lack of understand[ing] of the overall facts leading to the ‘coincidence’ reported or by the deliberate suppression of the facts, including when…AEFIs that result in death are made to ‘disappear.’”
- “It seems that huge business in [the] vaccine industry is affecting [the] science of vaccines and we are developing various ways to promote the business at the cost of human lives. …Going for a less sensitive tool for safety concerns is not only illogical but risky for the children of the world.”
Unfortunately, many vaccine proponents appear to be more concerned with forestalling “misconceptions” and “erroneous conclusions about cause and effect” than they are about preventing and identifying adverse events following vaccination. The result, as Dr. Puliyel argues, is that doctors who “naïvely” accept biased reports on vaccine safety “are losing the trust of the public and in the process…endangering public health.”
Read the entire article at the World Mercury Project.