Full FDA Approval=Fake News? EUA simply extended?
(media.greatawakening.win)
Comments (95)
sorted by:
Do people not read or is this intentional?
The EUA is for ages 12-15. The Approval is for 16+ year old. This is a FDA approval for everyone over 16 years old.
Come on guys. You're better than this.
Correct. From the FDA doc:
BLA Approval = FDA Approval
From FDA's site:
https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101
Yep, we already had this discussion in my post that was removed. Who pinned this shit?
OP here; it's not shit, I'm asking the question and crowd sourcing the investigation
Cool it's been debunked. So delete it now...
So delete the top brilliant response along with it?
That would be a waste of a crowd sourcing effort.
So edit the post.
I've been seeing a lot of shit thats been pinned.
Literal shill shit pinned saying trump looked like shit and there's now way he's coming back.
Now this which took a total of 10 mins of fact checking to debunk.
Both in the same week.This place almost as bad as reddit with their garbage. We have to be better...
You haven’t been on Reddit recently then?
Thankfully not. I try not to go around sticking my head in the shit pile
Reddit is liberal/bot echo chamber. You should check it out every once in a while to reset your meter.
Though, I do agree. I’m scratching my head at a lot of pins lately. Are we being subverted by a china mod? Are we misleading glowies who stalk here? What are these mods doing?
Still vaxxing 12-YOs with almost 0 change of getting the coof.
FDA Approval means shit, though it may come back to ruin them when it's proven they blinded the trial participants necessary and much more corruption and criminality.
It’s a hot topic, and pinning it will mean that more people will get the correct information here in the comments.
This
Come on OP, what's with all this facts and research business? Couldn't even give us a fews hours to get emotional?
Not so fast. Please read my post on this thread. BLA does mean full approval. Only parts of the EUA not covered by the BLA remain under the EUA.
This
What is BLA?
Biologics License Application. In other words, full FDA approval.
Biden now calls for US "companies" to mandate the vaccine.
https://greatawakening.win/p/12jwR3jprd/war-of-attrition--they-want-to-e/c/
They want to bar us from having an income.
the White House is exempted.
THIS! 👆
No income=Government control
u/#q4245
Nothing has really changed in that arena. The same exemptions that applied under the EUA also apply under approval. Religious and medical exemptions are available. That is no guarantee a person will keep their job, but we still must fight them on this. EUA or not, no one can be forced to undergo a medical treatment. Our struggle is between the rights of the individual and those supposed rights of the collective - freedom versus the state.
We knew this was coming. That is why I have been advising people to shift their strategies of objecting to the EUA and to develop other reasons for objection because the EUA argument was going to be taken off the table. Anyone that spent time and money in an attempt to fight this on grounds of EUA mandates has had some of the wind taken out their sails. Those cases will become useful for future precedent when they manage to make their way through the system, but it will not be of much help to us in the present struggle. Hang in there Patriots. This is not going to be easy. But we have no choice if we want to survive and save the lives of our children. God bless you all.
😸😸😸
why is this stickied, I and others have posted links from FDA website showing full approval. What are you mods doing?
Right. Same. I’ve been seeing tons of dumbass stickies while quality researched info gets buried.
This was sticked. Mine was deleted.
Full approval for 16+? Or did I misunderstand.
correct that is how I read it.
Question. How do I sticky my own posts? And I do I sticky my own comments at the top of a thread? I know it can be done. Been seeing a lot of that.
I am not aware of a way to sticky your own posts, I thought mods did it.
I had never seen or heard the word Comirnaty until today. What I get from this that it's the European version, approved by Swiss and European regulators, and this is telling us it is the same formulation as Pfizer and can be used interchangeably. Do we just accept and believe that it actually IS the same???
Comirnaty is their brand name for the product - like Bextra, Advil, Humira etc. They applied for the formal name and trademark back in March, it's just that EU trademark regulators accepted it before the US.
If you read the whole thing, one of the changes they must make is the package insert- to include updated refrigeration requirements, expiration dates, full list of ingredients and additional warnings (myocarditis is one of them).
Did you see the ingredient list? Package insert
Additional update: Watch the following video. Karen Kingston has really drilled into some of the ingredients. Can you say graphene oxide? STEW PETERS WITH KAREN KINGSTON - FORMER PFIZER EMPLOYEE CONFIRMS POISON IN COVID 'KILL SHOT
Mmmm. Everyone loves a little PEG in the veins.
Can't wait for the real biochem nerds to break this all down. It is the nanoparticle lipids I am interesting in. Of course they only listed them as lipids and did not include the nano part. We are pretty certain the Pfizer has graphene in it so we will need to track that down and find out where they are hiding it. Sometimes you have to search suppliers of the makers of the ingredients to hit paydirt - they can be several layers removed. But yes, Americans have been primed for years to be sensitive to PEG - food and toothpaste. Been telling patients for years not to use toothpaste and mouthwashes - not just because of the fluoride, but also because of the PEGs. Non aluminum baking soda is still the best choice. Charcoal isn't bad either.
Look up ditetradecylacetamide on DDG. Pubchem and Springer take you to the research, including scholarly papers written about the ability to cross the blood-brain barrier and anaphylactic reactions, and how they're different between the nanolipids, PEG, and sucrose.
The real juicy stuff is digging through the associated patents which leads to the companies involved, partnerships, financial backers, etc. But, I will leave that to those more suited for the task like Karen Kingston and Dr. David Martin. If you have not seen what they have pulled together you are missing out. These patent links are the smoking gun for the plandemic house of cards.
No, not at first glance and not at face value.
No, not at first glance and not at face value.
I'm trying to make sense of this as well.
I believe what the language may in fact be stating is that the EUA is still in use for children 16 years and younger, but full approval granted for everyone else.
Either way, this is NOT the full approval that the MSM will be reporting.
Having to read several paragraphs buried past MSM headlines they do state it’s still EUA for 12-15 yo. Full approval for 16+ Which is weirdly not the headline.
Either way, they are contradicting themselves. Approved for 16+ is not full approval.
An expansion of the EUA was approved to include children’s jab & they gave the bioweapon a new name. The jabs themselves, ALL OF THEM HAVE NOT RECEIVED FULL FDA approval, the satanists and their word salad documents purposefully confuse everyone, especially the retard ‘n’ chief.
Yes clearly not they are misleading headlines.
We’re all 15 years old now
Lol, I identify as a 15 y/o and my pronoun is boy.
🥇 🏆 winner!! 🏆 🥇
Identify as 15 years old.
If a man thinks he’s a woman, and all allowances be made for them, then we are what we think too, and therefore we can say we are 15 years old😀
You are correct. Only certain usage still remains under the EUA. The BLA has given the named product full FDA approval for ages 16 and up.
Did they approve the APPLICATION or did they approve the PRODUCT?
Is this simply just confirmation that the application is now officially in the system and waiting to be formally approved?
Here is the formal approval letter:
https://www.fda.gov/media/151710/download
The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. PREVENTION? That’s rich……
There is some disagreement on what "approved" actually means here. So I thought I would share my findings:
Right from the "FAQ"
https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna
Will the emergency use authorization (EUA) for Pfizer-BioNTech COVID-19 Vaccine remain in effect after the approval?
The EUA will continue to cover adolescents 12 through 15 years of age and the administration of a third dose to certain immunocompromised individuals 12 years of age and older. **Additionally, the EUA will continue to cover the use of the Pfizer-BioNTech COVID‑19 Vaccine in individuals 16 years of age and older until sufficient approved vaccine can be manufactured and distributed. **
From the letters:
https://www.fda.gov/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine#comirnaty (You need to read the letter titled "Letter of Authorization (reissued)" seriously, read it in its entirety.)
**
I honestly think what is happening here is that the FDA is extending/changing the EUA for the shot, while also doing a rebranding to this new name. OR they have "approved" what still remains under an Emergency Use Auth.... I have no idea what that means or the consequences of such.
I think the fake news is then running with it to instill the fear and panic as they tend to do. I'm never taking it, but I am not sure what is going on here.
Please DYOR and don't take what I am showing here as gospel. I could be completely wrong
Thanks for your explanation. What jumped out at me is that there is still an EUA for the old vax until sufficient quantities of new vax are available. Yet there's a push for mandates now. Sounds to me like a 4th booster is on the way.
Yes. That means that whatever particular recipe was in the experimental jabs is anyone's guess. They will use those up first while the public thinks they are approved. What a bunch of slimeballs.
I identify as a 12 year old. That should buy me at least a few months before these monsters push through approval for children.
Sauce: https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
https://www.fda.gov/media/150386/download
https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine
Are those lipid particles held together by graphene oxide?
That is where the biochem nerds are going to find some goodies I am sure. It may all be buried by a couple of layers, but there are some already that have found links to the companies that make the graphene oxide. Karen Kingston has really drilled into this. STEW PETERS WITH KAREN KINGSTON - FORMER PFIZER EMPLOYEE CONFIRMS POISON IN COVID 'KILL SHOT
I guess The White House is also posting fake news?
SMH, frens... we should not be surprised, we saw this coming.
Are there still people here that trust ANY 3 letter government agency to save them?
From The White House Official Facebook Page:
HCQ works. Thank you.
"and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA."
Do not be confused with the language. The EUA will remain in effect for those uses not spelled out in the "approved" BLA. Does the acceptance of a BLA mean full approval? Yes. The BLA is a full FDA approval folks. The EUA would have to be examined for those specific uses not spelled out in the BLA - those uses have extended EUA.
A company receiving a BLA for their product can introduce the now named product into interstate commerce and market it for its approved uses. A BLA also has no defined end date — assuming no significant problems emerge, the product can stay on the market indefinitely. Isn't that a joke? EUAs are time sensitive and have expiration dates. Full approval means it can be prescribed also for off label use. Just what they need - more ways to poison people. In short order, this move will eliminate the competition trying to apply for EUAs of their own inoculations. Gee, who stands to benefit? The remaining players on the EUA field at the moment are also applying for BLAs and we should start seeing those rolling out in the next several months.
The bottom line is that this is not an extended EUA, but indeed a politically and financially motivated full FDA approval. We will see if it has the desired effect that they were hoping for - to get those waiting on the sidelines to roll up their sleeves and get the clot shot.
Fuck these corrupt, gaslighting motherfuckers
So it looks like the FDA approved a new name for the vaccine and it remains under EUA. They were just creating a document the Biden admin could use and lie about a full approval? I will have to read more in depth later. Gotta run
Just remember the past logic failure in medicine which was used (This is important example: 1) People who had medical problems for which testing revealed no cause (i.e. agent orange) were then labeled by doctors as having psychiatric problems and prescribed drugs, which then created more medical issues which were then explained away as a exacerbation of psychiatric issues. The faulty logic was that an absence of explanation by current testing presumed a psychiatric origin. The doctors then made the complete jump to labeling the patient as having psychiatric problem when logically they could NOT make this assumption because medical tests DO NOT HAVE CAPABILITY of figuring out All medical conditions. And the only truthful conclusion doctors could truthfully make is that a patient's unexplained medical condition could be psychological OR MEDICAL. So, when the government now starts giving any clear or confusing rationale for mandating the death shot, SCREW 'EM.
Unstick please
Camirnitay sounds like a retarded way of saying community.
Language is confusing, CommiesRNaughty is full fda approved for 16 and older. The unbranded Pfizer-Biontech extends eua (same drug, different name, need to use up doses in the field), and the new branded CommiesRNaughty gets eua to jab 12 year olds.
EUA is for 12-15 year old kids. This post is fake news.
So can they now be sued for all the deaths and harm it's going to cause?
Very misleading. So no full approval. An extension for the 'authorised' Pfizer, addition of Covirnaty and update of expiration date. For the 'authorised' Pfizer. Losers.
Here's FDA's own statement. Read the first two paragraphs. It's fully authorized for use in people 16+ and is ALSO EUA'd for 12-15 yr old children.
"Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.
FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S."
FDA Evaluation of Safety and Effectiveness Data for Approval for 16 Years of Age and Older The first EUA, issued Dec. 11, for the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older was based on safety and effectiveness data from a randomized, controlled, blinded ongoing clinical trial of thousands of individuals.
To support the FDA’s approval decision today, the FDA reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.
Specifically, in the FDA’s review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.
Additionally, the FDA conducted a rigorous evaluation of the post-authorization safety surveillance data pertaining to myocarditis and pericarditis following administration of the Pfizer-BioNTech COVID-19 Vaccine and has determined that the data demonstrate increased risks, particularly within the seven days following the second dose. The observed risk is higher among males under 40 years of age compared to females and older males. The observed risk is highest in males 12 through 17 years of age. Available data from short-term follow-up suggest that most individuals have had resolution of symptoms. However, some individuals required intensive care support. Information is not yet available about potential long-term health outcomes. The Comirnaty Prescribing Information includes a warning about these risks.
Ongoing Safety Monitoring The FDA and Centers for Disease Control and Prevention have monitoring systems in place to ensure that any safety concerns continue to be identified and evaluated in a timely manner. In addition, the FDA is requiring the company to conduct postmarketing studies to further assess the risks of myocarditis and pericarditis following vaccination with Comirnaty. These studies will include an evaluation of long-term outcomes among individuals who develop myocarditis following vaccination with Comirnaty. In addition, although not FDA requirements, the company has committed to additional post-marketing safety studies, including conducting a pregnancy registry study to evaluate pregnancy and infant outcomes after receipt of Comirnaty during pregnancy.
The FDA granted this application Priority Review. The approval was granted to BioNTech Manufacturing GmbH."
Here's the relevant bit, posted earlier
https://greatawakening.win/p/12jwR2bzJB/full-fda-approvalfake-news-eua-s/
All still EUA. BLA not full approval either.
Full-on gobbledygook. ComirNaty has been placed on the same schedule as Pfizer still under EUA.
So fucked, your forced to take shit that could very well kill you, the govt is paying for it and if you get fucked up you are on your own and get to foot the financial damages. Fucking clown world.
The EUA only remains in effect for uses not spelled out in the BLA - such as for children.