Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique

Abstract

The World Health Organisation (WHO) has recently revised how adverse events after immunization (AEFI) are classified. Only reactions that have previously been acknowledged in epidemiological studies to be caused by the vaccine, are classified as a vaccine-product–related-reaction. Deaths observed during post-marketing surveillance are not considered as “consistent with causal association with vaccine”, if there was no statistically significant increase in deaths recorded during the small Phase 3 trials that preceded it. Of course, vaccines that caused deaths in the control-trials stage would not be licensed. After licensure, deaths and all new serious adverse reactions are labelled as ‘coincidental deaths’ or ‘unclassifiable’, and the association with vaccine is not acknowledged. The resulting paradox is evident. The definition of causal association has also been changed. It is now used only if there is “no other factor intervening in the processes.” Therefore, if a child with an underlying congenital heart disease (other factor), develops fever and cardiac decompensation after vaccination, the cardiac failure would not be considered causally related to the vaccine. The Global Advisory Committee on Vaccine Safety has documented many deaths in children with pre-existing heart disease after they were administered the Pentavalent vaccine. The WHO now advises precautions when vaccinating such children and this has reduced the risk of death. Using the new definition of causal association, this relationship would not be acknowledged and lives would be put at risk. In view of the above, it is necessary that the AEFI manual be revaluated and revised urgently. AEFI reporting is said to be for vaccine safety. Child safety (safety of children) rather than vaccine safety (safety for vaccines) needs to be the emphasis.

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“…Others who used the tool (e.g. Puliyel et al) reported similar issues we observed [69]. First, when using the WHO tool, in ICSRs reporting immunization errors the errors are directly assumed causally related to each of the reported AEFI.…”

The coverage of medical injuries in company trial informed consent forms

“…The failure to endorse an obvious link between treatment and a closely related event fits with current World Health Organization advice to investigators in trials to make every effort to avoid linking injuries to vaccines [17][18][19].…”

Adverse events following COVID-19 vaccination among pregnant women attending primary health centers: An active-surveillance study

“…According to the WHO-AEFI scale, causality can be graded as certain, probable, possible, unlikely, unrelated, and unclassifiable. 13 …”