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New Guidelines from WHO Put Children's Life At
Risk: Paediatricians
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."
The revised classification by WHO "is a major
step backward for patient safety," the authors say, adding, "This
could embolden vaccine manufacturers to be more reckless with regard to adverse
reactions.".
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 new 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 for the
success of immunization programmes."
Adverse reaction and deaths may not show up as
significantly increased in small safety studies. However, records of all deaths
and serious adverse events following vaccinations should be maintained and
periodically reviewed for safety signals.
According to the authors, WHO's new AEFI
classification scheme "that allows for an outright denial of any new
causative association with vaccination" could fall foul of Article 2 of
the European Convention on Human Rights. Adverse reaction and deaths may not
show up as significantly increased in small safety studies. However, records of
all deaths and serious adverse events following vaccinations should be
maintained and periodically reviewed for safety signals.
"Paradoxically, the AEFI algorithm is said to be
for vaccine safety," says Puliyel. "Perhaps we need a scheme for
public safety rather than vaccine safety."
Di atas adalah merujuk kepada
kesan langsung atau kesan serta merta apabila vaksin diberikan kepada kanak
kanak. Bagaimana dengan kesan jangka panjang vaksin kepada kesihatan kanak
kanak ? Adakah vaksin boleh menyebabkan penyakit kanser atau merosakkan organ dalaman
kanak kanak untuk jangka panjang ? Pihak mana yang membuat kajian untuk perkara
ini?
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