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Tuesday, August 24, 2021

Children’s Health Defense criticism of the FDA's vaccine approval...

Friends,


FDA Grants Full Approval of Pfizer Vaccine, Critics Blast Agency for Lack of Data, Scientific Debate
(Thanks to Dianne Irving and others for cluing me in on this. Highlights mine.)

Critics said it was concerning that full approval was based on only six months’ worth of data — despite clinical trials designed for two years — and that there was no public discussion of the data.
by Megan Redshaw

Critics accuse FDA of ‘unprecedented, naked power grab’

...

According to an article published Aug. 20 in the BMJ (N.B. BMJ is the "global healthcare knowledge provider with a vision for a healthier world. We share knowledge and expertise to improve healthcare outcomes."), transparency advocates have criticized the FDA decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval — an important mechanism used to scrutinize data.

Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”

But in a statement to The BMJ, the FDA said it did not believe a meeting was necessary ahead of the expected full FDA approval.

An FDA spokesperson said the agency held numerous meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) related to COVID vaccines in 2020, and did not believe a meeting was needed related to this biologics license application for Pfizer.

[AnP note: Oh, great. Rush it all through, discontinue the placebo "control" group utterly necessary in any sort of "science" experiment, and then drop public advisory committee hearings. THIS is "science"?]

According to the BMJ, companies typically apply for full approval after a longer period has elapsed so that more data are available for review.

Kim Witczak, a drug safety advocate who serves as a consumer representative on the FDA’s Psychopharmacologic Drugs Advisory Committee, said the decision removed an important mechanism for scrutinizing the data.

“These public meetings are imperative in building trust and confidence especially when the vaccines came to market at lightning speed under emergency use authorization,” said Witczak. Wticzak was one of 27 experts who launched a citizen’s petition demanding the FDA “slow down and get the science right” before approving COVID vaccines.

“The public deserves a transparent process, especially as the call for boosters and mandates are rapidly increasing,” Wticzak said. “These meetings offer a platform where questions can be raised, problems tackled and data scrutinised in advance of an approval.”

Witczak said it’s concerning that full approval is based on only six months’ worth of data — despite clinical trials designed for two years — and there’s no control group after Pfizer offered the product to placebo participants before the trials were completed.

“They know they can’t win this argument on the science and that’s why they had to abolish the public process and independent oversight,” said Children’s Health Defense Chairman Robert F. Kennedy Jr. “They believe themselves so powerful now that they are stripping off all pretenses that this is about public health, and are baldly revealing the corruption.”

Kennedy told The Defender:

“This is a sinister scheme for mandating a badly flawed vaccine that has already made history with record deaths and injuries, that neither prevents disease nor transmission, and does not improve mortality. Pfizer’s most recent six-month data show that while the jab prevents some COVID deaths, it causes more heart attacks yielding a net loss of life.”

Diana Zuckerman, president of the National Center for Health Research, told The BMJ it’s obvious the FDA has no intention of hearing anyone else’s opinion, and says making decisions behind closed doors can feed vaccine hesitancy.

AnP again: I encourage everyone to read the full Children's Health Defense criticism.

And remember: whatever anyone, ANYONE tells you, THIS is our reality:
We now even have the specter of people needing critical or life-saving surgery being told they must submit to becoming fully vaccinated before they will be accommodated.

The powers-that-be care so much about our health they are basically telling us to “eff off” and die unless we agree to be vaccinated. One gets the distinct impression that our rulers would love to deport all of us MAGA-wearing unvaccinated types and replace us with refugees from anyplace that has no history or concept of individual liberty and the rule of law.         

The elites are telling us what we can and can’t do, where we are not allowed to go and that we likely can't have gainful employment. What are they afraid of?  Either the vaccinations work and they are protected or they don’t and they are lying.  I am sick and damn tired of the fulminations of those who purport to care yet use this pandemic to put their knees on the throats of those with whom they disagree. You do not shun people, ban them from public spaces, mock them as idiots, deny them gainful employment – and life-saving surgery – out of concern for their well-being.
[Ron: This last sentence needs shouted from the rooftops.]
Plainly put, these frauds are conducting the biggest hoax, power play and act of evil in human history, all while attempting to cloak themselves in virtue-signaling glory. Sound vaguely familiar?

An Préachán
PS The Children's Health Organization is Robert F. Kennedy's group, and mainstream critics will just call it an anti-vax nut house, but after more than a year researching Covid and since January, the history of vaccines, I can honestly say that if even half of what I've found out about vaccines is true, no one would want ANY vaccine. (Edward Jenner was supposed to have saved the world from smallpox in the later 1700s but England's worst outbreak was in the vaccine-mandated 1840s, and so on.) But on top of that, of course, the Covid "vaccines" don't even fit the definition of "vaccine".  
https://childrenshealthdefense.org/ 


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