New Guidelines from WHO on AEFI Put Children’s Life At Risk

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06 July 2018

Two leading paediatricians in India have urged the World Health Organization (WHO) to urgently revise its manual on classification of Adverse Events Following Immunization (AEFI), warning that the new guidelines put children’s life at risk.

This needs to be done “urgently in the interest of child safety,” Doctors Jacob Puliyel at St Stephen’s Hospital in Delhi, and Pathik Naik of Children Hospital in Surat, say in a report published in the prestigious journal ‘F1000Research’

Under WHO’s revised manual on AEFI, only those adverse reactions observed during clinical trials of a vaccine, should be classified as vaccine related. All new serious adverse reactions including deaths seen during post-marketing of the vaccine should be considered as ‘coincidental’ or ‘unclassifiable’, and the vaccine should not be blamed.

The WHO has also changed the definition of “causal association,” the doctors say. Under the revised guidelines, if there is an alternate explanation for the adverse event, or another factor is involved, causative association with vaccine should not be made.

“In other words, if after vaccination, a child with an underlying congenital heart disease develops cardiac failure, it would not be considered causally related to the vaccine.”

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