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World Health
Organization’s New Lax Vaccine Safety Policy Leads to More Child Deaths by
Vaccines
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by Brian Shilhavy
Editor, Health Impact News
Editor, Health Impact News
Two leading pediatricians in India have
published a critique of the World Health Organization’s (WHO) newly
revised manual on the classification of Adverse Events Following Immunization.
The doctors claim that the new guidelines are
too lax, resulting in more children dying from adverse reactions to vaccines,
with no accountability for the vaccine manufacturers to produce safer vaccines.
In the U.S., pharmaceutical companies
manufacturing vaccines cannot be sued due to faulty vaccines, which allows them
to put as many vaccines into the market as they want, with no repercussions if
the vaccine proves to be faulty or have a high injury and death rate. Victims
must sue the U.S. government and top DOJ attorneys who protect the drug
companies. (See quarterly
reports from the DOJ on vaccine injuries and deaths here.)
This move by the WHO may very well be an
attempt to protect drug companies manufacturing vaccines by preventing lawsuits
in the rest of the world for faulty vaccines.
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.”
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