Share:

" />
Published On: Mon, Jul 10th, 2017

Experts urge WHO to urgently revise its post-vaccination philosophy

nsnbc : Two leading doctors and experts in immunization from India have urged the World Health Organization (WHO) to urgently revise its methodology to classify adverse events following immunization. (AEFI).

Research Sqeeze

Research Sqeeze

Dr. Jacob Puliyel, a pediatrician and member of the National Technical Advisory Group on Immunization, and Anant Phadke, an executive member of the All India Drug Action Network argue that WHO’s methodology does not address children’s safety. Doctors Puliyel and Phadke styled an urgent letter to the WHO, published in the Indian Journal of Medical Ethics, on July 4, 2017, are stressing that they are :

“…Concerned about the changes effected by the WHO to the assessment methodology of adverse events following immunization (AEFI), which, according to Puliyel and Phadke, make it almost impossible to classify adverse events (deaths in this case) noticed for the first time in phase IV post-marketing surveillance, as “consistent causal association to immunization” (full letter HERE)

The authors stress that the WHO’s new classification of  AEFI, in essence, implies that no death can result from  vaccination and, if any death does occur, it is  only coincidental and not due to the vaccine.

One of the major, and potentially dangerous flaws with the methodology is, according to Puliyel and Phadke, that only reactions that have been previously acknowledged in epidemiological studies   can be considered as vaccine related in the new scheme.

All deaths   seen in   large post marketing phase are simply labeled as coincidental   or unclassifiable deaths. They can therefore not be classified as vaccine related if the vaccine had not caused a statistically significant increase in deaths in the small Phase 3 trials.

In their letter, published in the prestigious Indian Journal of Medical Ethics, Puliyel and Phadke have expressed their concerns over this new classification system. “By simply denying deaths, the new AEFI classification is liable to miss the safety signals and therefore potential dangers with new vaccines.”

The authors note that Sri Lanka suspended the use of a pentavalent vaccine after five deaths within four months after its introduction in January 2008 and, in 2013 and Viet Nam shelved the  pentavalent vaccine   because it had been associated with 12  deaths.  However, in both cases, the WHO teams which investigated the deaths declared they were ‘unlikely’ to be related to the vaccines used.

The authors point out that the consequences of using the new classification are illustrated starkly in the causality assessment of 132 serious AEFI cases uploaded on the website of the Ministry of Health and Family Welfare in India.

78 of these babies survived and 54 died. Among those who survived, the causality assessment shows nearly 50%, were reactions to the vaccine.  On the other hand not even one death was classified as vaccine related.  96% deaths were simply classified as unclassifiable or coincidental.

“The resulting paradox is evident,” Puliyel and Phadke point out. “If a child is admitted to hospital with intractable convulsions after vaccination, if it survives, the reaction could be classified as vaccine-product–related, but if it dies it will be classified as ‘coincidental death’”.

WHO has redefined ‘cause and effect’ in AEFI. According to the revised AEFI

Manual, the term ‘causal association’ refers to “a cause and effect relationship between causative factor and a disease with no other factor intervening in the processes”. This would mean that AEFI in children with an underlying heart disease who may develop symptoms of cardiac de-compensation after vaccination (due to a vaccine-caused elevation in temperature or stress from a local reaction at the site of vaccination), would not be considered causally related to the vaccine although vaccination contributed to cardiac failure in this specific situation.

This is of particular concern since the Global Advisory Committee on Vaccine safety documented that a large number deaths in children after receiving Pentavalent vaccine were those with some pre-existing heart disease, the authors say.  “The new definition of ‘cause and effect’ is potentially harmful to children with underlying diseases as it removes the impetus to provide them special care during immunization,” the authors note.

“In view of the above, it is necessary that the WHO’s  AEFI manual be reevaluated and revised urgently” the authors said  pointing out that AEFI reporting is meant to ensure that vaccines given to children are safe. “Safety of children (child safety) rather that safety for vaccines (vaccine safety) needs to be the emphasis,” the authors point out.  “Also many ambiguities in evaluating AEFI under the new classification scheme erode confidence in the scheme’s ability to evaluate rare adverse events and act decisively to protect children.”

CH/L – nsnbc 10.07.2017

About the Author

- nsnbc international is a daily, international online newspaper, established in 2013. nsnbc international is independent from corporate, state or foundation funding and non-partisan. nsnbc occasionally republishes selected articles from other media. Republication of articles does not imply that we agree with media's editorial policy. nsnbc international is free to read and free to subscribe to. We appreciate and depend on modest donations from our regular readers; such as the equivalent of the price of one print newspaper per month.

Leave a comment

XHTML: You can use these html tags: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>