Tag Archives: WHO

WHO new Vaccine Adverse Reaction Guidelines (2018) Hides ADR’s post vaccination

 

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.

READ SOURCE ABSTRACT

 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  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.” (END)

 Jacob Puliyel MD MRCP M Phil

puliyel@gmail.com

Phone 0091 9868035091

REVISED Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique [version 2; referees: 2 approved]

OPEN PEER REVIEWREFEREE STATUS

The World Health Organisation (WHO) has recently revised how adverse events after immunization (AEFI) are classified. Only reactions that have previously been acknowledged in epidemiological studies to be caused by the vaccine are classified as a vaccine-product–related-reaction. Deaths observed during post-marketing surveillance are not considered as ‘consistent with causal association with vaccine’, if there was no statistically significant increase in deaths recorded during the small Phase 3 trials that preceded it. Of course, vaccines  noted to have caused a significant increase in deaths in the control-trials stage would probably not be licensed. After licensure, deaths and all new serious adverse reactions are labelled as ‘coincidental deaths/events’ or ‘unclassifiable’, and the association with vaccine is not acknowledged. The resulting paradox is evident. VLA Comment: INTERESTING POINT IN PINK
The definition of causal association has also been changed. It is now used only if there is ‘no other factor intervening in the processes’. Therefore, if a child with an underlying congenital heart disease (other factor), develops fever and cardiac decompensation after vaccination, the cardiac failure would not be considered causally related to the vaccine. 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. The WHO now advises precautions when vaccinating such children. This has reduced the risk of death. Using the new definition of causal association, this relationship would not be acknowledged and lives would be put at risk. In view of the above, it is necessary that the AEFI manual be revaluated and revised urgently. AEFI reporting is said to be for vaccine safety. Child safety (safety of children) rather than vaccine safety (safety for vaccines) needs to be the emphasis.

 

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Brazil: Babies born with shrunken brains after pregnant mother receives new TDaP

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WHO “Safety of Immunization During Pregnancy Report 2014

PDF Global Advisory Committee on Vaccine Safety

 

Compare the above Report from WHO to this:

This “shrunken brain” issue in newborns was just suddenly in Brazil as if someone flipped a switch, and the only way that could really happen is via the sudden arrival of a new brain destroying TDAP vaccine, which all pregnant Latin American women are strongly encouraged to get before week 22 of pregnancy. This perfectly matches the probable arrival of the real culprit – a tainted TDaP vaccine, which if administered in May (when this virus supposedly arrived) would be causing precisely the shrunken newborn baby brain problems Brazilians are having now, right on schedule.

Read more…

WHO Report Author changes “probable carcinogen” to “Glyphosate is definitely genotoxic

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RE: International death knoll about Monsanto’s Round Up and GMO agriculture

Glyphosate is “definitely genotoxic”, says Prof Chris Portier, a co-author of the report by the World Health Organization’s cancer agency, which classed glyphosate as a probable carcinogen. 

Prof Christopher Portier, one of the co-authors of the recent report by the World Health Organization’s International Agency for Research on Cancer (IARC), which determined that glyphosate is a “probable” carcinogen, said at a scientific briefing today, “Glyphosate is definitely genotoxic. There is no doubt in my mind.”

“Genotoxic” means it damages DNA. At a briefing, Dr Robin Mesnage of the Department of Medical and Molecular Genetics at Kings College in London presented data showing Roundup is 1,000 times more toxic than glyphosate alone!  Read more…

WHO hires International Food & Beverage Alliance (Pepsi, Coca Cola) to market VACCINES

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To overcome worldwide resistance to vaccines, the UN’s World Health Organization (WHO) enlisted the marketing advice of the International Food and Beverage Alliance, whose 11 members comprise the world’s most successful marketers, among them The Coca Cola Company, Pepsico and McDonalds. WHO liked what it heard and, in a major report released last fall, decided to accept the food and beverage industry’s recommendations: forget facts, sell vaccines the way Coca-Cola is sold, on the basis of emotion.  Read more…