<div dir="ltr"><div class="gmail_default" style="font-size:large"><br></div><div class="gmail_default" style="font-size:large"><b><span>WHO'S NEW GUIDELINES<span> </span>PUT CHILDREN'S LIFE AT RISK<span></span></span></b>
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New Delhi, 6 July 2018.<span></span></span></p>
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Two leading pediatricians<span> </span>in India have
urged the<span> </span>World Health<span></span></span></p>
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Organization (WHO)<span> </span>to urgently revise
its manual on classification of<span></span></span></p>
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"Adverse Events Following Immunization (AEFI)," warning that the new<span></span></span></p>
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guidelines put children's life at risk.<span></span></span></p>
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This needs to be done "urgently in the interest of child
safety,"<span> </span>doctors<span></span></span></p>
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Jacob Puliyel at St Stephen's Hospital in Delhi, and Pathik Naik of<span> </span>Children<span></span></span></p>
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Hospital in Surat, say in a report published in the prestigious journal<span></span></span></p>
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?F1000Research?<span></span></span></p>
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Under<span> </span>WHO's revised<span> </span>manual on AEFI,<span> </span>only those adverse<span> </span>reactions<span></span></span></p>
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observed during<span> </span>clinical trials of a
vaccine,<span> </span>should be<span> </span>classified as<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt;font-size:12pt;font-family:Cambria"><span>><span> </span>vaccine related.<span> </span>All new serious adverse reactions
including deaths<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt;font-size:12pt;font-family:Cambria"><span>><span> </span>seen during post-marketing of the
vaccine<span> </span>should be considered<span> </span>as<span></span></span></p>
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?coincidental'<span> </span>or ?unclassifiable?, and
the vaccine should not be blamed.<span></span></span></p>
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The WHO has also changed the<span> </span>definition
of<span> </span>"causal association," the<span></span></span></p>
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authors say. Under the revised guidelines,<span>
</span>if there is an alternate<span></span></span></p>
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explanation for the adverse event, or another factor is involved, causative<span></span></span></p>
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association with vaccine should not be made.<span>
</span>"In other words,<span> </span>if after<span></span></span></p>
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vaccination,<span> </span>a child with an underlying
congenital heart disease<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt;font-size:12pt;font-family:Cambria"><span>><span> </span>develops<span>
</span>cardiac failure, it would not be considered causally related<span></span></span></p>
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to the vaccine."<span></span></span></p>
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The revised classification by WHO<span>
</span>"is a major step backward for patient<span></span></span></p>
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safety,"<span></span></span></p>
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the authors say.<span> </span>"This could
embolden vaccine manufacturers to be more<span></span></span></p>
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reckless with regard to adverse reactions," they warn.<span></span></span></p>
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Puliyel and Naik note that the Global Advisory Committee on Vaccine Safety<span></span></span></p>
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has documented many deaths in children with pre-existing heart disease<span></span></span></p>
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after they were administered the pentavalent vaccine (combined diphtheria,<span></span></span></p>
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tetanus, pertussis, Hib, and hepatitis-B vaccine).<span> </span>"Under<span>
</span>WHO's<span> </span>ne w<span></span></span></p>
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definition of causal association, these deaths would not be acknowledged as<span></span></span></p>
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related to<span> </span>vaccination."<span></span></span></p>
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Both Sri Lanka and Vietnam governments withdrew<span>
</span>the pentavalent vaccine<span></span></span></p>
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following the deaths of<span> </span>five children in
Sri Lanka and 12 in Vietnam soon<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt;font-size:12pt;font-family:Cambria"><span>><span> </span>after vaccination.<span> </span>But<span>
</span>WHO investigating teams declared that the<span></span></span></p>
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deaths were ?unlikely? to be related to vaccination, the report says.<span></span></span></p>
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The authors point out that<span> </span>a new study
in India, <span> </span>showed that the<span></span></span></p>
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switch from DPT (diphtheria, tetanus, pertussis)<span> </span>to pentavalent vaccine<span></span></span></p>
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almost doubled the deaths following vaccination. "A large number of these<span></span></span></p>
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deaths could have been avoided had the AEFI manual not been revised."<span></span></span></p>
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According to their<span> </span>report, the
consequence of India adopting WHO's new<span></span></span></p>
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classification<span> </span>can be seen from the
causality assessment of 132 serious<span></span></span></p>
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AEFI cases uploaded on the website of the Ministry of Health and Family<span></span></span></p>
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Welfare.<span> </span>Of the total AEFI cases,<span> </span>54<span>
</span>babies died and 78 survived,<span>
</span>"but<span></span></span></p>
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not even one death was classified as vaccine-related. Nearly all the deaths<span></span></span></p>
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were simply classified as unclassifiable or coincidental."<span></span></span></p>
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Vaccines are drugs used as a preventive measure, given to<span> </span>healthy<span></span></span></p>
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persons.<span> </span>. Adverse events following
immunization<span> </span>must be monitored<span></span></span></p>
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more carefully than other drugs, the authors note. "A credible
immunization<span></span></span></p>
<span style="font-size:12pt;font-family:Cambria">> safety evaluation and monitoring system is
essential.</span></div><div class="gmail_default" style="font-size:large"><span style="font-size:12pt;font-family:Cambria">======</span></div><div class="gmail_default" style="font-size:large"><span style="font-size:12pt;font-family:Cambria"><p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span>It
is disturbing and continues to prevail without any explanation from WHO ! There
seems to be some interest behind this. <span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span>Needs
serious discussion among people and professionals in countries?<span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span>What
is the best way to intervene other than write a letter that may be ignored? <span></span></span></p>
<p class="MsoNormal" style="margin:0in 0in 0.0001pt"><span>Arun
Gupta<span> </span>[Also received notes to this avail
from Mira Shiva and Vandana Prassad].<span></span></span></p>
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