Hasta la Pasta Italia Accepts Parental Proof of Vaccination Status
Autism’s Tag, You’re It

WHO's New Guidelines Put Children's Health At Risk

Indian infantNew Delhi
Jacob Puliyel MD MRCP M Phil

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  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

[This press release has been written with help from an experienced science reporter]

 

 

 

The article can be accessed here.

 https://f1000research.com/articles/7-243/v2

 

How to cite: Puliyel J and Naik P. Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique. F1000Research2018, 7:243 (doi: 10.12688/f1000research.13694.2)

Comments

cia parker

A friend sent me that article about the baby teeth and autism. It's only marginally relevant. For one thing, until 2002 the hep-B vaccine at birth had a lot of mercury, and susceptible babies stored it and reacted with many neurological deficits (like my daughter, born in 2000). How do they propose to separate mercury from baby vaccines and mercury from prenatal sources?

I have described here how my mother reacted to the mercury-laden diphtheria vaccine when she was four. She was a susceptible, and stored much of it, handing it down to me and my brother. Yes, mercury can be given to fetuses by the mother. We both reacted with encephalitis to our first DPT at three months old, also mercury-laden, but it may be that we would not have been as severely affected with Asperger's as we would have been had we not accumulated mercury from our mercury-laden mother. And then my nephew and my daughter reacted to vaccines as well, he with Asperger's more severe than ours, and my daughter with autism the most severe of any of us. Again, mercury in the vaccines, but added to the mercury stored in our brains pre-natally from vaccines the mother had received. It doesn't acquit vaccines in any way.

Angus Files

Spot on Wendy exactly correct.

This one from America not a care in the world and backed by the WHO..

When big pharma breaks the law, prosecute the CEO

"Reporters circled, and the finance committee of the US Senate investigated, forcing GSK to hand over internal documents."

https://www.newscientist.com/article/mg20827826-900-when-big-pharma-breaks-the-law-prosecute-the-ceo/

Pharma For Prison

MMR RIP

Wendy Stephen

Two vaccines in particular jump to mind when reading this, Pandemrix and Pluserix. Both turned out to be highly problematic and were removed from use in the UK because of serious adverse events which were not detected at the outset in the epidemiological studies or in the feedback from clinical trials.

Back in the eighties, Pluserix MMR containing the Urabe mumps strain was trialled in Scotland commencing in May 1987, seventeen months before it was launched nationally in October 1988. Feedback from the trial did not highlight a risk of aseptic mumps meningitis in the post vaccination period. However, after only eleven months of marketing the Committee on Safety of Medicines reported on ten cases of aseptic meningitis, a figure which continued rising until the authorities were forced to stop using the vaccine in 1992 because of an unacceptably high risk of aseptic meningitis in recipient children.

The risk identified was not entirely new since the vaccine had previously been removed from use in Canada where authorities questioned a link between the vaccine and aseptic meningitis evidencing the fact that some aspects of the Scottish clinical trial, (perhaps the size of the cohort), was not sufficiently robust, and the side effect was not detected.

The situation with Pandemrix, a vaccine introduced at the height of the swine flu pandemic in 2009 was similar, in that it too, went on to be associated with a very serious adverse event, primarily in children ie. narcolepsy. Numerous trials and studies did not detect this problem. It too was removed from use and there are a number of legal actions currently pending in the UK.

Both products highlight the need for continued high level post marketing surveillance after the launch of a vaccine on to the market. Both evidence the fact that not all serious adverse reactions, later accepted as having been caused by the vaccine, are detected and quantified in pre marketing trials and studies at the outset.

In 2015, Lopalco and DeStefano in their paper highlighted the importance of continued post licensure monitoring of vaccines when they are used in what they described as, “real world settings”.

“While pre-licensure activities form the foundation for the development of effective and safe vaccines, post-licensure monitoring and assessment, are necessary to assure that vaccines are effective and safe when translated in real world settings.” (1)

The 2002 report by the MMR Vaccine Group in Scotland recognised the limitations of clinical trials.

“Before a product is marketed, experience of its safety and efficacy is limited to its use in clinical trials. The conditions under which patients are studied pre-marketing do not necessarily reflect the way the medicine will be used in hospital or in general practice once it is marketed. Consequently, there is a continued need for vigilance to detect adverse effects that become apparent after marketing and when the medicine is more widely used among a greater variety of patients.”(2)

Against that backdrop, one has to wonder where any party would garner support for only adverse events detected in clinical trials to be classified as vaccine related. History points to the fact that only after a vaccine is marketed is it possible to determine some types of adverse reactions. The public are entirely reliant on the various bodies charged with monitoring vaccine safety to address all aspects of vaccine usage not merely the data generated in trials and studies which are often financed and conducted by the industry.

The Scottish report outlined how a number of clinical trials which supported licensure of the MMR vaccine were controlled and financed by the industry.

“In accordance with the principles of good clinical practice, the majority of clinical trials that supported licensure of these five MMR vaccines, similarly to other medicinal products, were sponsored by the company, were conducted by investigators experienced in the field, and were monitored by company personnel.” (2)


Article 2 of the European Convention on Human Rights, charges States parties with ….

(1) A duty to protect people against the risk of harm from the activities of public authorities (3)

With regards to vaccine safety monitoring, that duty surely extends to identifying all potential vaccine associated events in both clinical trials and in the post marketing surveillance.

UNICEF’s Convention of the Rights of the Child, Article 36, protects children from any activity which might harm them.


Article 36 (Other forms of exploitation): Children should be protected from any activity that takes advantage of them or could harm their welfare and development.(4)


Failure to collate and monitor post marketing data in respect of vaccine adverse events allowing for the early detection of a safety issue and subsequent remedial action, thereby ensuring that the child is not exposed to a risk, would surely fall foul of Article 36

Given that the WHO endorses vaccination but acknowledge on their website that there is no “perfect” vaccine which is entirely safe for everyone,(5) surely they, more than any other party, would be recommending a system of vaccine safety monitoring which rather than disregard adverse events from the post marketing period as “vaccine related,” is mindful of what occurred with Pluserix and Pandemrix, advocating for the inclusion of all adverse events to be viewed as potentially vaccine related, irrespective of which phase of vaccine usage identifies a problem.


(1) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4596394/

(2) http://www.gov.scot/Publications/2002/04/14619/3783

(3) https://justice.org.uk/article-2/

(4) A summary of the rights under the Convention on the Rights of the Child UNICEF

(5) http://www.who.int/vaccine_safety/initiative/detection/AEFI/en/

Hans Litten

https://www.infowars.com/?s=del%20bigtree


The FDA have approved a new HepB vaccine after 14 deaths in the trials !!!

Laura Hayes

goTrump,

Thank you for succinctly stating the ugly truth that so few are willing to see or admit.

Someone

@Laura Hayes and others.
I was reading a New York Times article this morning about baby teeth findings linked to autism. The author is dr perri klass. There were 54 comments, some very interesting, but I found the ones related to vaccines very harshly dismissive. Since these may have a wide readership, perhaps some a of a readers would care to comment, especially in reply to "soundly debunked" type statements.

Barry

The WHO is certainly a part of the Global Elite, who want to have their share of “ruling the world” with the use of vaccines,

and it is much simpler than loading people onto railroad cars.
******

I'd call that a bulls-eye.

The only thing I would add, is that part of the vaccine plan is to disable our immune systems just enough... that although death is guaranteed, is usually doesn't happen right away.

It may take decades for that autoimmune disorder to kill you. During which time you become a guaranteed customer to one or more pharmaceutical drugs.

Pam

Hans,
Thank you for the link regarding Mrs Shine's comments.

The following is a link to take action from Autism Action Network

http://capwiz.com/a-champ/issues/alert/?alertid=80495626&queueid=11714045011

New White House staffer's wife attacked for telling truth. Corporate media denies autism epidemic and vaccine safety issues.
Please take action to send a message to the White House & let the President know that you too share Darla Shine's concern about the catastrophic rise in the number of people with autism, now 1 in 36 American children. And that you too are concerned about vaccine safety & want to see real action taken by the administration to protect our children from vaccine injury, and stem the exponential growth of the autism epidemic.

go Trump

The WHO is certainly a part of the Global Elite, who want to have their share of “ruling the world” with the use of vaccines,

and it is much simpler than loading people onto railroad cars.

Jeannette Bishop

Thank you, Drs. Puliyel and Naik!

Sam hall

Brave lady Mrs shine

Angus Files

Hans,

Telling the truth has become evil and punishable,what a lady.

Pharma For Prison

MMR RIP

Hans Litten

https://www.washingtonpost.com/amphtml/news/politics/wp/2018/07/06/white-house-officials-wife-tweeted-about-n-word-anti-vaxx-conspiracies-from-now-deleted-account-report/?noredirect=on

Shine also tweeted stories that put forth debunked information about the danger of vaccines at least a dozen times, Mediaite reported. Any link between autism and vaccines has been disproved by various studies over the years.

“Biggest national security threat is autism!” she wrote in a tweet that tagged Trump, according to the Huffington Post. “How can we run a country when half of all boys will be autistic by 2050?”

“1 out of 10 black boys has autism,” she wrote in another tweet.

Angus Files

Brave brave people of principal.

Pharma For Prison

MMR RIP

Laura Hayes

A perfect example that the evil doers, which most certainly includes the World “Health” Organization, are feeling so confident in their positions of power that they can openly put forth their evil deeds with absolutely no fear of repercussions.

As proof that those at the WHO are operating without any fear of reprisal or any potential accountability for what are blatant evil actions, NO world leader has spoken out in outrage! NO human rights group has spoken out, either! Doctors and their Pharma-funded trade industry groups remain silent, minus a few heroes, such as the authors of this article.

Clearly, the immoral people in positions of power can state plain as day that they will not only permit the disabling and killing of babies and children via vaccination, but they will endorse and ensure it. And with rare exception, the populace accepts this evil and atrocious behavior!

In my 2016 WAPF presentation, I devoted a chunk of time to reviewing the 5-day “safety” study for Merck’s Recombivax Hep B Vaccine, which did not include a control group, and which included only 147 carefully-selected subjects. The AEFI for the 5-day “study” period were terrible enough for a newborn to endure that the vaccine should never have been approved, and the AEFI reported post-marketing were horrific, yet the vaccine has never been recalled and prohibited.

Here is the link to watch/read the segment on Hep B:

http://www.ageofautism.com/2016/12/vaccines-what-is-there-to-be-pro-about-laura-hayes-to-weston-a-price-foundation-conference.html

I ended the section with these questions:

“For any of you here today who allowed this vaccine for your child, were you told about all of these potential side effects your child might experience, and possibly have to live with for the rest of their life? Were you told that there was no control group used when studying its effects in those aged 0 up to 10 years? Were you told that only 147 subjects in this age group were studied during clinical trials? Were you told the post-vaccination surveillance time period was only 5 days? Were you even told how your child could contract hepatitis B, and the extreme unlikelihood that that would happen during their infancy, toddlerhood, and childhood? If not, was your doctor practicing ethical medicine? Should he be liability-free when administering this vaccine to his patients? If he weren’t liability-free, would he be administering it?”

A heartfelt thank you to Drs. Puliyel and Naik for their ethical and caring behavior, for their boldness and courage to speak out, and for their dedicated persistence to continue exposing that which must be stopped.

White Rose

Let Puliyel and Naik be an example to the rest of you spineless doctors all around the world.

bob moffit

""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."

Ah yes .. what is needed is another "scheme for public safety" .. rather than a "scheme for vaccine safety".

WHO's "Ministry of Health and Family Welfare" reminds me of Orwell's "Ministry of Truth" .. where "war is peace" and "love is hate".

Amazing .. science is now reduced to the reliability stand of a "scheme".

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