FDA Requests to Take 55 YEARS to Fully Release Vaccine Data: Federal Lawsuit | Facts Matter
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Good evening.
Three days ago, the FDA made an almost unbelievable request to a federal judge.
And in that request, which I have right here, they asked whether they can take 55 full years to release all of the documents pertaining to the approval of the Pfizer vaccine.
Meaning that if this request is actually granted, we'll have to wait until the year 2076 to see all of the documents related to Pfizer's approval.
And then lastly, as all of this is taking place, the U.S. government has just approved a $5 billion purchase deal of Pfizer's new COVID pills.
However, that deal hinges on one question: whether these pills actually get emergency approval from the FDA.
Let's go through it all together.
This is your daily Facts Matter update, and I'm your host, Roman from the Epoch Times.
And actually, I'd like to start with an announcement.
Today is this program's one-year anniversary.
Exactly one year ago, on November 18th of 2020, we started this program to explore what exactly this graph was all about.
And now, a full year later, we're talking about global vaccine mandates.
It's kind of amazing if you think about it.
And if you've been watching this program from the start, well, I would like to give you a heartfelt thank you.
And then also, I would like to give a big shout out to Miss Sabrina, who has been the video editor behind the scenes for the past year.
She is the video magician who makes things like this possible.
Without her, I would just be a guy talking behind a green screen.
So a big shout out to Sabrina.
And now, let's begin today's discussion by talking about Pfizer.
Just three days ago, the FDA went to a federal judge and they asked him to allow them to take 55 full years to release all of the documents in their possession that pertain to the approval of the Pfizer vaccine.
Let me just repeat that.
The FDA went to a federal judge and they asked for permission to withhold the documents in their possession that are related to the approval of the Pfizer vaccine until 55 years from now.
Meaning that if this request is actually granted, the complete set of documents won't see the light of day until the year 2076.
Now I'd like to give you some background on this particular case.
What happened was that several months ago, a medical transparency group called Public Health and Medical Professionals for Transparency, they made a Freedom of Information Act request against the FDA.
And in that request, they essentially wanted the FDA to turn over all of the documents which were related to the authorization of the Pfizer vaccine.
Which you'd think wouldn't take too long given the fact that a typical authorization process takes many years to, However, the FDA approved the Pfizer vaccine only 108 days after it began to be manufactured.
However, as a response, the FDA claimed that it would take too long to release all of these documents at once, and so they wanted to negotiate on some kind of a release schedule.
However, after several months of back and forth, this group of medical doctors and the FDA, they were not able to agree on a schedule, and so this group of doctors filed a lawsuit in federal court against the FDA.
Here's part of the argument that these doctors were making about why this disclosure is important and why it needs to be made in a timely manner.
Quote, It took the FDA precisely 108 days from when Pfizer started producing the records for licensure on May 7, 2021, to when the product was licensed on August 23, 2021.
We assume, as the FDA has stated, that it conducted an intense, robust, thorough, and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure.
The FDA now has an equally important task of making those documents available to the plaintiff in this case and the public at large in at least the same time frame.
Now, just to pause here for a quick moment, essentially, this group of medical doctors are saying that the FDA took only 108 days to conduct their full review, and that all of their documents pertaining to the review process, they should be made public for the sake of transparency.
And then they continue in this statement to say that being transparent is actually a requirement, according to the FDA's own guidelines.
Here's what they wrote, quote, That's according to the Code of Federal Regulations, subsection 601.51.
Now, just to pause here for another quick moment, that particular federal regulation that is cited in that part of the lawsuit, you can find it over on the FDA's website, and it says in part, quote, And then in that same statute,
it lists some of the data that is to be disclosed, including all safety and effectiveness data and information, The list is actually pretty comprehensive if you go down it into the type of information that the FDA should be disclosing to the public immediately after a vaccine is approved.
And I mean, frankly, it's not ambiguous.
I mean, it's right there written in the statute.
However, according to this lawsuit, the FDA has not released a single page of documentation.
Here's in fact what the lawsuit states, quote, Not one page.
Now, as a response to this lawsuit, as we mentioned earlier, the FDA came out and they made a request of this federal judge.
They said, since there are in total more than 329,000 pages of documents that are related to the Pfizer approval, they are proposing to release 500 pages of documents per month.
They claim that at this particular pace, it would allow them time to redact sensitive information that they don't want released to the public.
However, the caveat is that if they release 500 pages per month, if you do the math, it will take the FDA 55 years to fully release all of the records.
Here's, in fact, part of what the FDA wrote in their filing to the court.
Quote, The FDA proposes to process and produce the non-exempt portions of responsive records at a rate of 500 pages per month.
Courts do not waiver from the standard 500 page per month processing rate even when a FOIA request would take years to process.
Now, on that last point, the FDA's argument is generally actually correct.
That 500 page per month rate is fairly standard practice for a FOIA request.
However, the medical doctors in this case, they are making the argument that for one, people across the country are at risk of losing their jobs, losing their livelihoods, as well as losing some of their rights to the vaccine mandates that have sprung up after the approval of the Pfizer vaccine.
And so in this extraordinary circumstance, the plaintiffs are arguing that Americans should have transparent access to the full breadth of documents which led to the Pfizer vaccines getting its approval, even if that proves inconvenient to the FDA. Here's in fact what the plaintiffs in the case, who are again these medical doctors, here's what they wrote as a part of their argument.
Quote, Certainly not on an issue this important.
And then secondly, the plaintiffs in the case, who are again this group of medical doctors, they make the case that since the FDA was able to handle an extremely complex task of approving a vaccine in just 108 days, when again that normally takes many years, therefore they argue that likewise there should be no reason that the FDA can't review all of the documents within that same time span, within 108 days.
Here's what they wrote, quote, this 180 day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer's COVID-19 vaccine.
The FDA is an organization comprised of more than 18,000 people with a budget of six billion dollars.
It has itself said that there is nothing more important than the licensure of this vaccine and being transparent about this vaccine.
Therefore, we respectfully request that the court enter an order requiring the FDA to produce all documents and data submitted by Pfizer on a rolling basis such that all of it shall be produced on or before March 3rd, 2022, which is 108 days from today.
Now, thus far, these arguments have just been submitted to the court, and the judge in the case, the federal judge that's presiding over this lawsuit, has yet to make a ruling.
Also, we here at the Epoch Times, we did reach out to the FDA for comment on this particular case, but we have yet to hear back.
Perhaps they are too busy going through the documents as we speak.
However, the lawyer who is representing the doctors in this case, he did come out with a statement, and here's part of what he said.
The FDA's promise of transparency is, to put it mildly, a pile of illusions.
It took the FDA precisely 108 days from when Pfizer started producing the record for licensure to when the FDA licensed the Pfizer vaccine.
Taking the FDA at its word, it conducted an intense, robust, thorough, and complete review and analysis of those documents in order to assure that the Pfizer vaccine was safe and effective for licensure.
While it can conduct that intense review of Pfizer's documents in 108 days, it now asks for over 20,000 days to make these documents available to the public.
Now, if you'd like to read more about this particular case, I will throw a link to both the PDF of this lawsuit as well as an article that goes through all the details into the description box below this video for you to check out.
And I will also throw a link to a cryotherapy chamber in case you need to freeze yourself in order to read these documents when they are finally released in the year 2076.
And all I ask in return is that you take a quick moment to smash, smash, smash that like button for the YouTube algorithm.
And now, before we move on over and continue our discussion of Pfizer, specifically about how they just secured a $5 billion contract with the U.S. government for their new COVID pills, I would like to take a quick moment and introduce our sponsor for today's episode, and I will do so from the sound booth.
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And now, Roman in the studio, back to you.
And now let's move on over and talk about the COVID pills.
According to U.S. government officials, just yesterday, Pfizer has reached a $5 billion purchase agreement with the U.S. government over their newly created COVID-19 pills.
The total deal is that the federal government will pay $5.3 billion for 10 million courses of the COVID pill treatment, which, if you do the math, it turns out to be $529 per course.
And according to Pfizer, the specific price of this course is due to, quote, high committed volume of treatment courses being purchased through 2022.
With the implication of that statement being that this treatment is inexpensive.
Now, this whole deal is actually still contingent on whether or not the FDA grants emergency use authorization to Pfizer's COVID pill, which for your reference is officially known as Paxlovid.
And also for your reference, this particular treatment has not yet been improved anywhere in the world.
However, just two days ago, Pfizer did submit an application for emergency clearance with the FDA. And among the documents that they submitted, they had this interim analysis right here, which suggests that the pill reduces the risk of both hospitalization as well as death in COVID patients.
Here's in fact how Pfizer's CEO described this new treatment.
It is encouraging to see a growing understanding of the valuable role that oral investigational therapies may play in combating COVID-19.
And we look forward to continuing discussions with governments around the world to help ensure broad access for people everywhere.
Now, we here at the Epoch Times, we did reach out to the FDA for comment on this COVID pill.
However, they declined to answer any questions regarding the Pfizer submission.
They wouldn't say whether they are going to clear the pill or not.
Although a spokesperson for the FDA did get back to us, they responded with this sort of generic statement.
All right, so there was actually something that I wanted to point out, and it has to do with a question that one of the readers of the Epoch Times posted on the side of the article that was talking about these new COVID pills.
And so, one of the top comments on the comment section was from a woman named Michelle Wolf, and here's what she wrote, quote, Now, those are actually two pretty good questions.
And as I mentioned earlier, we did reach out to the FDA for comment on everything that was happening, but they declined to give us an answer.
However, in regards to the first question, the question about the emergency use authorization when something else is already available, this new pill, it actually looks like it is a therapy for COVID patients, sort of like the monoclonal antibodies are.
So in theory, it wouldn't compete with the authorization for the Pfizer vaccine as it now stands.
That, at least in my opinion, is the situation as it relates to that.
The second question, in regards to the Comirnaty vaccine not actually being used here in the States, here in America, well, as far as I can tell, that is actually the case.
She is correct about that.
In fact, just a few weeks ago, we published this report here, which found that even though the Comirnaty Pfizer vaccine has been authorized by the FDA, the vaccines that are being used in America right now They don't have the Comirnaty label on them, meaning that the vaccines that are being used in America, they are the Pfizer vaccines, but they do not have the Comirnaty label.
They are the Pfizer biotech vaccines, the same ones that were used under the emergency use authorization, meaning that even after the emergency use authorization became the full authorization, the vaccines are still the same.
They're not the Comirnaty labeled vaccine.
So we actually conducted that earlier study, the one that I just showed you up on screen, by reaching out to the officials in 19 different states, and we also reached out to the pharmacies in places like New York, California, and Missouri, and they all confirmed to us that they were using the Pfizer vaccines without the Comirnaty label.
Now, we also did reach out to a spokesperson for Pfizer in order to, you know, see what was going on and get confirmation.
And they did actually confirm to us in an email saying that there are no doses of Comirnaty in the United States as of when they sent us that email, which was on October the 12th, 2021.
However, it is worth noting that the FDA's statement, the approval statement, when they approved the vaccine, the Pfizer vaccine, that approval statement did say that the Comirnaty vaccine, which is the official trade name, it had the same ingredients and it could be used interchangeably During the emergency use authorization phase of the vaccine rollout, You had the Pfizer-BioNTech vaccine, right?
So that was what was being rolled out to the different states.
However, after the approval came through, the approval was specifically for the Comirnaty-labeled Pfizer vaccine.
However, even after the approval, what is still being used across America is not the vaccine with the Comirnaty label, but is instead this earlier vaccine with the Pfizer-BioNTech label.
However, again, according to the official statement, these two differently labeled Pfizer vaccines, they are in theory actually the same.
They have the same ingredients.
In fact, here is what the Pfizer spokesperson emailed to us in a statement, quote, the FDA approved Comirnaty and the emergency use authorized Pfizer biotech COVID-19 vaccine have the same formulation and according to the FDA labeling can be used interchangeably to provide the COVID-19 vaccination series.
However, it is worth noting that the lawyers who are representing Americans across the country who are challenging the vaccine mandates that have sprung up, they are making the argument that the lack of availability of the Comirnaty vaccine, which is the official vaccine that has been authorized, It actually means that the vaccine mandates that have sprung up are unlawful.
Here's in fact what Mr.
Matthew Staver, who is the chairman of the Liberty Council, which is a Christian legal group, here's what he told us here at the Epoch Times.
Under the emergency use authorization, everyone has an option to accept or refuse the product.
And that means every person, military and civilian.
And so this is critical.
All of the mandates from the military to the civilian population are violating federal law.
So he's basically saying, That under emergency use authorization, people had the option to not accept taking the vaccine.
However, after it was officially approved, some people, like those, for instance, in the military, they no longer have that option.
But since the vaccine that is being used is labeled officially as that previously emergency use authorized vaccine, he is saying that they are breaking the law.
And he further went on to say that the situation would be different if the Comirnaty vaccine was available, but since it's not, well, here's exactly what he said, quote, You cannot interchange Biotech's Comirnaty with Pfizer's shot from a legal standpoint.
They are legally distinct.
Now again, this particular report was published back in October, so about a month ago, and I'm not sure whether the situation has actually changed or not since then, whether the Comirnaty vaccine is now being used.
We should actually do a follow-up report on that.
Regardless, until then, if you would like to read more about the details of these two different labeled Pfizer vaccines that are being used here in America, I'll throw a link in the description box below and then I'll go back into the studio and discuss the rest.
If you'd like to read more about this new COVID pill or the new deal that was just struck with the federal government, I'll throw all that into the description box below this video for you to check out.
And again, I'll ask in return is that if you haven't already, take a quick moment to smash, smash, smash that like button for the YouTube algorithm.
And now, since you've completed this episode of Facts Matter, I would highly recommend that you go on over to Epic TV and check out an awesome episode of Wide Angle, where Brandon explores the question of what would happen to this world if China decides to attack Taiwan.
Here's a trailer for that episode.
100% less serious about invasion.
And as their country has got wealthier, they've had more resources to invest in a military that has significant capabilities that can potentially deter the United States.
Would and should America defend Taiwan if the CCP invades?
Marine space in Japan certainly could be there within 24 hours.
If you want to check out that full episode as well as all the other phenomenal content over on Epic TV, I'll throw a link to it.
It'll be right there at the very top of the description box.
I hope you click on it.
I hope you check it out.
I hope you subscribe.
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And then, until next time, I'm your host, Roman from the Epic Times.