The FDA Did Not “APPROVE” The Pfizer Vaccine, They AUTHORIZED it For Use. EUA = Emergency Use Authorization
As has been stated before. Words, deployed like weapons, create our reality. The language forms our perception. This is spelling. Language spoken or written. Incantations. ( words that are believed to have a “magical effect”.)
This is real world magic. The words used(employed, stated, written) give you beliefs (that which you think to be true) If you don’t understand that concept yet… then seriously you are as thick as a brick! It’s so in your face. It’s in plain sight
Advertising. Propaganda. Weasel wording. Memes. All these methods of manipulation using language to implant/control your thoughts and ideas. This is casting a spell. As in ancient times, except for now in this our modern world the manipulation is done through the mass media. So it affects larger numbers of people. Hence our present day pandemic of fear.
The FDA didn’t ‘approve’ Pfizer’s COVID-19 vaccine. Here’s why
“Yet none of this was enough for the vaccine to win official FDA approval. What it got instead was a more limited emergency use authorization.
Blame it on the pandemic.”
(A pandemic was declared… words were stated and or written- the spelling was done)
“During a public health emergency, it’s imperative to develop new medicines and vaccines as quickly as possible.”
Alternative criteria is used.. and the drug, injection or medicine is not the biggest factor in the decision making
“So the agency uses an alternative evaluation process that’s designed to vet things more quickly than the usual FDA approval regimen. If a drug or vaccine passes muster, it’s granted an emergency use authorization, or EUA.
An EUA can be used on a brand-new medical product or on an existing one that has already been approved for another purpose. They’re not limited to vaccines — under the right circumstances, an EUA can be granted to anything used to “diagnose, treat, or prevent serious or life-threatening diseases or conditions,” the FDA explains.
What are those conditions?
For starters, the country needs to be in an official, specific kind of public health emergency. Secretary of Health and Human Services Alex Azar declared that the coronavirus triggered a nationwide public health emergency that began on Jan. 27, but that declaration doesn’t count because it was issued under the Public Health Service Act.”
First: An official declaration kicked off the public health emergency which was necessary for an emergency use authorization- Declaration- a formal or explicit statement or announcement.
“The legislation that matters is the Federal Food, Drug and Cosmetic Act, a law passed in 1938 that empowered the FDA to regulate medications, among other things. Azar issued a public health emergency under this law that was effective as of Feb. 4.
Another important condition for issuing an EUA is that “there are no adequate, approved, and available alternatives” to the product being authorized. That’s certainly the case with vaccines against COVID-19, a disease that only came on the scene at the end of 2019″
Second, no adequate or approved and available alternative. What’s the criteria for it being decided there was no adequate or approved alternative? Was it because it was claimed to be “novel”. Corona viruses are hardly novel. Been known about for decades and decades and affect humans, cats, minks, etc., Was there really no adequate or available alternative? Really? Vitamin D and Zinc looked adequate. As did other cheaper alternatives.
“An experimental vaccine being considered for emergency use authorization still must be tested in multiple rounds of clinical trials. In Phase 1, the candidate vaccine is given to a small number of healthy people at gradually increasing doses to make sure it’s safe and well-tolerated. A Phase 1 trial might provide some preliminary information about ideal dosages as well.
Next comes a Phase 2 study, which involves more volunteers testing various doses. At this point, the study will branch out to include people with a variety of health conditions, not just those who are in great shape. This is also when a vaccine is first compared head-to-head against a placebo.
If no safety issues crop up, things proceed to Phase 3. Thousands of study volunteers from a variety of backgrounds are randomly assigned to receive either the vaccine or the placebo. This type of study helps researchers measure the effect of the vaccine. For instance, in Phase 3 trials of the Pfizer-BioNTech vaccine, eight of the 17,411 people who were given the vaccine wound up becoming sick with COVID-19, compared with 162 of the 17,511 who got the placebo. Using that and other data, researchers determined that the vaccine was 95% effective at preventing COVID-19.
To be considered for an EAU, a Phase 3 vaccine trial should include “well over 3,000” participants, and at least half of them should be tracked for at least two months after receiving their final dose“
Third consideration over 3000 participants tracked for at least two months after receiving their final dose. This is it for a vaccine that will doled out to billions! Seems inadequate. Massively insufficient and fudged data is acceptable for emergency use authorization.
“Once sufficient data are in hand, the FDA can decide whether emergency use authorization is warranted. Doctors and scientists on the agency’s staff pore over the study results. So do the independent scientists and health experts on the agency’s Vaccines and Related Biological Products Advisory Committee.
In the case of a vaccine, authorization can be granted if “the known and potential benefits outweigh the known and potential risks,” the FDA says.”
Fourth: Authorization can be granted if “the known and potential benefits”outweigh the risks All data for this decision provided by the companies making the vaccines, of course. Can you say “conflict of interest”?
“The agency also assesses the company’s ability to consistently produce high-quality doses of its vaccine.”
Fifth– Can the manufacturer produce high quality vaccines? Are the companies going to say, state or report that they can’t?
“Granting emergency use authorization isn’t the end of the story. Once an authorized vaccine goes out to the public, its manufacturer must keep track of any serious side effects that befall those who take it, especially adverse events that result in hospitalization or even death.”
Sixth: the population at large are the test subjects as the experiment goes public
“The FDA, the Centers for Disease Control and Prevention and other government agencies will do their own safety monitoring as well. If the FDA ever determines that the benefits of the vaccine no longer outweigh the harms, the emergency use authorization can be revoked.
An EUA can last only as long as a public health emergency is in effect. But scientists anticipate that the coronavirus will continue to circulate in humans even after the COVID-19 pandemic ends. In that case, vaccine makers that want to keep their products on the market will need to have regular FDA approval — and to get it, they’ll need to keep their Phase 3 clinical trials going.And that’s probably what they’ll do.
The FDA said it expects vaccine makers who receive emergency use authorizations to “continue to collect placebo-controlled data in any ongoing trials for as long as feasible” so they can apply for regular approval“
I’ve already read suggestions that it would be cruel to continue the placebo studies- I expect they will not continue- in the name of ‘fighting’ this scourge.
* Added Sunday December 13/20. Note the absence of animals studies prior to the human testing for this vaccine?
Updated: I stand corrected Gwen has brought to my attention 1 Pfizer animal study which was not peer reviewed and was not to be published in the media
bioRxiv is receiving many new papers on coronavirus SARS-CoV-2. A reminder: these are preliminary reports that have not been peer-reviewed. They should not be regarded as conclusive, guide clinical practice/health-related behavior, or be reported in news media as established information.
Therefore it’s pretty safe to maintain there was no peer reviewed verifiable/established animal studies. Which might be why there has been so little information in this regard?