PHM-Exch> WHO'S NEW GUIDELINES PUT CHILDREN'S LIFE AT RISK

[Claudio Schuftan]

*WHO'S NEW GUIDELINES  PUT CHILDREN'S LIFE AT RISK*

> New Delhi, 6 July 2018.



> Two leading pediatricians  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

> authors 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."



> The revised classification by WHO  "is a major step backward for patient

> safety,"

>

> the authors say.  "This could embolden vaccine manufacturers to be more

> reckless with regard to adverse reactions," they warn.

>

> Puliyel and Naik note that 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 (combined diphtheria,

> tetanus, pertussis, Hib, and hepatitis-B vaccine).    "Under  WHO's  ne w

> definition of causal association, these deaths would not be acknowledged
as

> related to  vaccination."

>

> Both Sri Lanka and Vietnam governments withdrew  the pentavalent vaccine

> following the deaths of  five children in Sri Lanka and 12 in Vietnam soon

>   after vaccination.  But  WHO investigating teams declared that the

> deaths were ?unlikely? to be related to vaccination, the report says.

>

> The authors point out that  a new study in India,    showed that the

> switch from DPT (diphtheria, tetanus, pertussis)  to pentavalent vaccine

> almost doubled the deaths following vaccination. "A large number of these

> deaths could have been avoided had the AEFI manual not been revised."

>

> According to their  report, the consequence of India adopting WHO's new

> classification   can be seen from the causality assessment of 132 serious

> AEFI cases uploaded on the website of the Ministry of Health and Family

> Welfare.  Of the total AEFI cases,  54   babies died and 78 survived,
"but

> not even one death was classified as vaccine-related. Nearly all the
deaths

> were simply classified as unclassifiable or coincidental."

>

> Vaccines are drugs used as a preventive measure, given to   healthy

> persons.  . Adverse events following immunization   must be monitored

> more carefully than other drugs, the authors note. "A credible
immunization
> safety evaluation and monitoring system is essential.
======

It is disturbing and continues to prevail without any explanation from WHO
! There seems to be some interest behind this.

Needs serious discussion among people and professionals in countries?

What is the best way to intervene other than write a letter that may be
ignored?

Arun Gupta  [Also received notes to this avail from Mira Shiva and Vandana
Prassad].
-------------- next part --------------
An HTML attachment was scrubbed...
URL: <http://phm.phmovement.org/pipermail/phm-exchange-phmovement.org/attachments/20180709/b0b79789/attachment.html>