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How Pfizer Manipulated COVID Vaccine Trial Protocols To Obtain Emergency FDA Authorisation For Children
greatgameindia.com/ ^ | July 5, 2021 | GreatGameIndia

Posted on 08/08/2021 9:45:39 AM PDT by ransomnote

Analysis and comparison of the review document submitted by Pfizer to the US Food and Drug Administration, on the basis of which the FDA gave the green light to expand the emergency permit for vaccination also for children aged 12-15 (1), as opposed to the study protocol in children (2, 3), reveal concerning findings, including violations of the protocol established by Pfizer itself, and no less serious, designing the trial protocol in a way that will allow the company to present as positive findings as possible in terms of vaccine safety in children.

According to the review document submitted by Pfizer to the FDA, four of the 1,131 children in the study arm who received Pfizer-BioNTech COVID-19 Vaccine suffered from serious adverse events (“SAEs”) – that is, events in which at least one criterion was met: caused death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or congenital anomaly/birth defect.

Of these four children, three had such severe depression that they were hospitalized shortly after vaccination (in the first 7 days after the first dose, in the second only one day after the second dose, and in the third 15 days after the first dose, respectively).

Violation of protocol conditions – How did children with a psychiatric diagnosis get to be included in the study?

According to the review document submitted by Pfizer to the FDA, four of the 1,131 children in the study arm who received Pfizer-BioNTech COVID-19 Vaccine suffered from serious adverse events (“SAEs”) – that is, events in which at least one criterion was met: caused death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, or congenital anomaly/birth defect.

Of these four children, three had such severe depression that they were hospitalized shortly after vaccination (in the first 7 days after the first dose, in the second only one day after the second dose, and in the third 15 days after the first dose, respectively).How Pfizer Manipulated Trial Protocols To Obtain Emergency FDA Authorisation Of COVID Vaccines For Children

The consequence of this finding is extremely worrying, as it means that one in every 350-400 children who are vaccinated might suffer from severe depression and need hospitalization.

To reassure us, Pfizer notes in its review document that in fact, all three children had a pre-existing diagnosis of anxiety and depression. Moreover, they explain – all three actually reported a selective serotonin reuptake inhibitor (SSRI) that began within 1-2 months prior to vaccination.

“Worsening suicidal ideas with initial SSRI treatment in adolescents”, they explain, “is a recognized risk and provides a reasonable alternative explanation for depression exacerbation in these BNT162b2 recipients”.

So here you go – why blame the vaccine, when there is a perfectly reasonable and logical alternative explanation for the exacerbation of their depression?

MORE AT LINK


TOPICS: Miscellaneous
KEYWORDS: newnarrativesource

1 posted on 08/08/2021 9:45:39 AM PDT by ransomnote
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To: ransomnote

The vaccine industry is pure evil and fraudulent

https://phoreveryoung.wordpress.com/2015/05/14/the-worst-cover-up-in-the-history-of-the-world-vaccinations-are-monkey-business/

1800- 1920

-

1798 General vaccine programs against cowpox instituted in the US.

1801 First widespread experimentation with vaccines begins.

1802 The British government gives Edward Jenner £10,000 for continued experimentation with ‘smallpox vaccine.’ The paradigm that vaccines provide ‘lifetime immunity’ is abandoned, and the concept of ‘re-vaccination’ is sanctioned.

1822 The British government advances Edward Jenner another £20,000 for ‘smallpox vaccine’ experimentation. Jenner suppresses reports which indicate his concept is causing more death than saving lives.

1844 Fredrich Loeffler isolated the diphtheria bacillus from the throats of patients.

1881 Sternberg in his own lab isolated the pneumococcus

1882 Robert Koch isolates the tubercle bacillus

1883 Robert Koch isolates the cholera bacillus.

1883 Max Von Pettenkofer suggested that Koch’s bacteria were only one of the many factors in the causation of cholera. He prepared test tubes thick with lethal cholera bacteria and he and several of his students drank them down with no side affects.

1888 Bacteriological Institute opens in Paris for experimentation with animals and production of vaccines and sera. Other institutes open around the world modeled after the Paris Institute.

1888 Bacteriological Institute in Odessa, Russia tries its hand at a vaccine for anthrax. Over 4500 sheep are vaccinated; 3,700 of them die from the vaccination.

1909 New York Press, January 26, 1909 publishes a report by W.B. Clark which states, ‘cancer was practically unknown until cowpox vaccination began to be introduced. I have seen 200 cases of cancer, and I never saw a case of cancer in an un-vaccinated person.’ Scientific evidence begins to mount that where human lymph is employed in a vaccine, syphilis, leprosy and TB soon follow. Where calf lymph is employed in the creation of a vaccine, TB and cancer soon follow. (Cancer and Vaccination by Esculapius).

1911 The head of French Public Health for the French Army said that germs alone were ‘powerless to create an epidemic.’

1912 First whooping cough (Pertussis) vaccine created by two French bacteriologists, Jules Bordet and Octave Gengou, who wanted to use it in Tunisia. After they grew Pertussis bacteria in large pots, they killed it with heat, mixed it with formaldehyde (used to embalm bodies) and injected it into children.

“Vaccinations, Not a Virus, Is Responsible for Spanish Flu – 1918”

– Dr. Robert O. Young
The pH Miracle Living Center
http://www.phmiracleliving.com

1933 a British science team to identify the first filterable bacteria in man, yet propaganda says that the virus of Spanish flu killed millions of civilians and soldiers during the pandemic from 1918 to 1920.

Many would have us believe that all those American soldiers who died from non-combatant causes died from Spanish flu. However, U.S. Army records show that seven men died after being vaccinated.

A report from U.S. Secretary of War Henry L Stimson, the deaths were not only verified but also there had been 63 deaths and 28,585 cases of hepatitis reported as a direct result of yellow fever vaccination during only six months of the war. Plus, the yellow fever vaccination was only one of the 14 to 25 shots given to recruits.

1911 vaccinations became a requirement in the U.S. Army. Cases of typhoid and vaccinial diseases increased rapidly, according to Army records.

1917 The death rate from typhoid reached the highest point in the history of the U.S. Army after America entered the war.

In 1917, 19,608 men were admitted into army hospitals due to anti typhoid inoculation and vaccinia, according to a report of the Surgeon-General of the U.S. Army; and this doesn’t take into account others whose symptoms were attributed to other causes. The army doctors knew all these cases of disease and death were due to vaccination and were honest enough to admit it in their medical reports. Army doctors tried to suppress the symptoms of typhoid with a stronger vaccine, however it caused a worse form of typhoid, paratyphoid. They then concocted an even stronger vaccine to suppress the previous one and created an even worse disease–Spanish flu.

After the war, this was one of the vaccines used to protect a panic-stricken world from the soldiers returning from WWI battle fronts infected with dangerous diseases.

The rest is history.

1918 Great influenza epidemic attributed to widespread use of vaccines that killed up to 100 million people.

1921 BCG tuberculosis vaccine developed.

1922 A study by Samuel Torrey Orton connects emotional disturbance with neurological problems. This insight was lost after World War II when psychology, psychiatry and psychoanalysis became popular, breaking the connection. The emotional disturbances caused by vaccines then became financial fodder for the new psych-industries. With the causes suppressed, a new industry was born.


2 posted on 08/08/2021 10:28:00 AM PDT by Truthoverpower (Arizona !!!! Now the TRUMP TRAIN is getting back on TRACK ! TRUTH! FREEDOM ! LIBERTY! )
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To: ransomnote

Vaccine manufacturers not following their own protocols to get govt clearance (pronounced- No Liability).

Hell, has any established protocol been followed in the last 2 years? This is the most screwed up pandemic in history because we haven’t done anything in the established way of doing things? What could go wrong? I mean exactly how FUBAR does it have to get for you folks??


3 posted on 08/08/2021 12:05:29 PM PDT by Delta 21 (Get off your ass and earn it !)
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To: ransomnote
DISCLAIMER: Just because the globalist depopulation oligarchs war-gamed a global coronavirus pandemic lockdown so they could force experimental “vaccines” with an unprecedented number of catastrophic adverse reactions upon every human being on the planet to combat a weaponized virus they paid the Chinese Communist Party's Wuhan Lab to create and release into the wild does NOT mean anything nefarious is afoot.® 🤡
4 posted on 08/08/2021 12:07:50 PM PDT by E. Pluribus Unum ("Communism is not love. Communism is a hammer which we use to crush the enemy." ― Mao Zedong)
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To: ransomnote

“The consequence of this finding is extremely worrying, as it means that one in every 350-400 children who are vaccinated might suffer from severe depression and need hospitalization.”

No, it doesn’t. Talk about twisted logic. It’s quite a stretch to come to that conclusion when the 3 were -already- taking SSRIs for clinical depression prior to getting the vaccine. And likely continued in the exact same environment (lockdown/noschool/familydeaths) that fostered that clinical depression before the vaccine.

Additionally, the article claims the fourth subject received a vaccine but the fourth subject is clearly listed under ‘placebo’ and had appendicitis. Good grief


5 posted on 08/08/2021 3:33:17 PM PDT by blueplum ("...this moment is your moment: it belongs to you... " President Donald J. Trump, Jan 20, 2017) )
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